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1.
Langenbecks Arch Surg ; 409(1): 50, 2024 Feb 02.
Article in English | MEDLINE | ID: mdl-38305912

ABSTRACT

BACKGROUND: Aim of the current study was to present the results of the implementation phase of a robotic liver surgery program and to assess the validity of the IWATE difficulty score in predicting difficulty and postoperative complications in robotic liver surgery. METHODS: Based on the prospective database of the Interdisciplinary Robotic Center of Ulm University Hospital, the first 100 robotic liver surgeries were identified and analyzed. Perioperative parameters (duration of surgery and blood loss) and postoperative parameters including morbidity, mortality, and length of hospital stay were assessed and the results were compared between different IWATE difficulty categories. RESULTS: From November 2020 until January 2023, 100 robotic liver surgeries were performed (41 female, 59 male; median age 60.6 years, median BMI 25.9 kg/m2). Median duration of surgery was 180 min (IQR: 128.7), and median blood loss was 300 ml (IQR: 550). Ninety-day mortality was 2%, and overall morbidity was 21%, with major complications occurring in 13% of patients (≥ grade 3 according to Clavien/Dindo). A clinically relevant postoperative biliary leakage was observed in 3 patients. Posthepatectomy liver failure occurred in 7% (4 Grade A, 3 Grade B). Duration of surgery (p < 0.001), blood loss (p < 0.001), CCI (p = 0.004), overall morbidity (p = 0.004), and length of hospital stay (p < 0.001) were significantly increased in the IWATE 'expert' category compared to lower categories. DISCUSSION: Robotic surgery offers a minimally invasive approach for liver surgery with favorable clinical outcomes, even in the implementation phase. In the current study the IWATE difficulty score had the ability to predict both difficulty of surgery as well as postoperative outcomes when assessing the complexity of robotic liver surgery. Therefore, the role of the IWATE score in predicting these outcomes highlights its importance as a tool in surgical planning and decision-making.


Subject(s)
Laparoscopy , Liver Neoplasms , Robotic Surgical Procedures , Robotics , Humans , Male , Female , Middle Aged , Robotic Surgical Procedures/adverse effects , Robotic Surgical Procedures/methods , Laparoscopy/methods , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Liver , Retrospective Studies , Length of Stay , Hepatectomy/adverse effects , Hepatectomy/methods
2.
Trials ; 24(1): 363, 2023 May 30.
Article in English | MEDLINE | ID: mdl-37254179

ABSTRACT

BACKGROUND: Pancreatic ductal carcinoma (PDAC) is the fourth most frequent cause of cancer-related death in the Western world, and its incidence is rising. In patients that undergo curative resection, local recurrence (LR) is frequent. A recently described surgical technique of extended pancreatoduodenectomy (PD) termed the TRIANGLE operation has been proposed as a promising approach to reduce LR and improve disease-free survival in PDAC patients. METHODS: The TRIANGLE trial is a multicentre confirmatory randomised controlled superiority trial with two parallel study groups. A total of 270 patients with suspected or histologically confirmed pancreatic head cancer scheduled for PD will be included in the trial and randomly assigned to the intervention group (extended PD defined as Inoue level 3 dissection along the superior mesenteric and celiac artery as well as removal of all soft tissue in the so-called triangle between the celiac artery, the SMA and the mesenterico-portal axis) or the control group (conventional PD with lymphadenectomy and removal of soft tissue according to current guidelines). The primary endpoint of the trial will be the disease-free survival of patients. Other perioperative outcomes as well as oncological parameters and patient-reported outcomes will be analysed as secondary outcomes. DISCUSSION: Despite multimodal treatment, LR remains high and disease-free survival is limited following PD for PDAC. The TRIANGLE operation could address these shortcomings of conventional PD as indicated in several retrospective studies. However, this technique could be associated with more adverse events for patients including intractable diarrhoea. The TRIANGLE trial will close the evidence gap as well as offer a risk-benefit assessment of this more radical approach to PD. TRIAL REGISTRATION: German Clinical Trials Register DRKS00030576 (UTN U1111-1243-4412) 19th December 2022.


Subject(s)
Carcinoma, Pancreatic Ductal , Head and Neck Neoplasms , Pancreatic Neoplasms , Humans , Pancreaticoduodenectomy/adverse effects , Pancreaticoduodenectomy/methods , Retrospective Studies , Pancreas/surgery , Carcinoma, Pancreatic Ductal/surgery , Head and Neck Neoplasms/surgery , Randomized Controlled Trials as Topic , Multicenter Studies as Topic , Pancreatic Neoplasms
3.
Med Image Anal ; 86: 102770, 2023 05.
Article in English | MEDLINE | ID: mdl-36889206

ABSTRACT

PURPOSE: Surgical workflow and skill analysis are key technologies for the next generation of cognitive surgical assistance systems. These systems could increase the safety of the operation through context-sensitive warnings and semi-autonomous robotic assistance or improve training of surgeons via data-driven feedback. In surgical workflow analysis up to 91% average precision has been reported for phase recognition on an open data single-center video dataset. In this work we investigated the generalizability of phase recognition algorithms in a multicenter setting including more difficult recognition tasks such as surgical action and surgical skill. METHODS: To achieve this goal, a dataset with 33 laparoscopic cholecystectomy videos from three surgical centers with a total operation time of 22 h was created. Labels included framewise annotation of seven surgical phases with 250 phase transitions, 5514 occurences of four surgical actions, 6980 occurences of 21 surgical instruments from seven instrument categories and 495 skill classifications in five skill dimensions. The dataset was used in the 2019 international Endoscopic Vision challenge, sub-challenge for surgical workflow and skill analysis. Here, 12 research teams trained and submitted their machine learning algorithms for recognition of phase, action, instrument and/or skill assessment. RESULTS: F1-scores were achieved for phase recognition between 23.9% and 67.7% (n = 9 teams), for instrument presence detection between 38.5% and 63.8% (n = 8 teams), but for action recognition only between 21.8% and 23.3% (n = 5 teams). The average absolute error for skill assessment was 0.78 (n = 1 team). CONCLUSION: Surgical workflow and skill analysis are promising technologies to support the surgical team, but there is still room for improvement, as shown by our comparison of machine learning algorithms. This novel HeiChole benchmark can be used for comparable evaluation and validation of future work. In future studies, it is of utmost importance to create more open, high-quality datasets in order to allow the development of artificial intelligence and cognitive robotics in surgery.


Subject(s)
Artificial Intelligence , Benchmarking , Humans , Workflow , Algorithms , Machine Learning
4.
Trials ; 24(1): 76, 2023 Feb 01.
Article in English | MEDLINE | ID: mdl-36726155

ABSTRACT

BACKGROUND: Incisional hernia is a frequent complication following loop ileostomy reversal. Incisional hernias are associated with morbidity, loss of health-related quality of life and costs and warrant the investigation of prophylactic measures. Prophylactic mesh implantation at the time of surgical stoma reversal has shown to be a promising and safe method to prevent incisional hernias in this setting. However, the efficacy of this method has not yet been investigated in a large multicentre randomised-controlled trial (RCT) with adequate external validity. The P.E.L.I.O.N. trial will evaluate the efficacy of prophylactic mesh reinforcement after loop ileostomy closure in decreasing the rate of incisional hernia versus standard closure alone. METHODS: P.E.L.I.O.N. is a multicentre, patient- and observer-blind RCT. Patients undergoing loop ileostomy closure will undergo intraoperative 1:1 randomisation into either abdominal wall closure with a continuous slowly absorbable suture in small-stitch technique without mesh reinforcement (control group) or abdominal wall closure with an additional reinforcement with a retromuscular non-absorbable, macro-pore (pore size ≥ 1000 µm or effective porosity >0%) light-weight monofilament or mixed structure mesh. A total of 304 patients (152 per group) will need to be randomised in the study. Based on inclusion and exclusion criteria, 1,014 patients are expected to be screened for eligibility in order to recruit the necessary number of patients. The primary endpoint will be the frequency of incision hernias within 24 months according to the European Hernia Society definition. Secondary endpoints will be the frequency of surgical site occurrences (including surgical site infections, wound seromas and hematomas, and enterocutaneous fistulas), postoperative pain, the number of revision surgeries and health-related quality of life. Safety will be assessed by measuring postoperative complications ≥ grade 3 according to the Dindo-Clavien classification. DISCUSSION: Depending on the results of the P.E.L.I.O.N. trial, prophylactic mesh implantation could become the new standard for loop ileostomy reversal. TRIAL REGISTRATION: DRKS00027921, U1111-1273-4657.


Subject(s)
Abdominal Wound Closure Techniques , Incisional Hernia , Surgical Stomas , Humans , Incisional Hernia/etiology , Incisional Hernia/prevention & control , Ileostomy/adverse effects , Surgical Mesh/adverse effects , Incidence , Abdominal Wound Closure Techniques/adverse effects
5.
J Interprof Care ; 36(4): 552-559, 2022.
Article in English | MEDLINE | ID: mdl-35297739

ABSTRACT

Interprofessional training wards (IPTW) are a form of interprofessional education enabling trainees of different healthcare professions to work together in teams. Concerns about patient safety are a major barrier to the implementation of IPTWs. The objective of this retrospective study was to analyze patient relevant clinical outcomes on Germany's first IPTW (Heidelberger Interprofessionelle Ausbildungsstation; HIPSTA) in the Department of Surgery at University Hospital Heidelberg in comparison to a conventional surgical ward (CSW). The setting is a large tertiary care center with a focus on major oncological surgery. The endpoints were postoperative complications according to the Dindo-Clavien Classification and a set of patient-safety outcomes. In total, 232 patients treated on HIPSTA were retrospectively compared with 465 patients on a CSW. Baseline characteristics were comparable between groups. No significant difference between rate or severity of overall postoperative complications was observed. In-hospital mortality did not significantly differ between groups. However, the mean length of hospital stay was significantly shorter on HIPSTA. Furthermore, HIPSTA patients had less frequent reoperations. Patient safety in surgical IPTW was not compromised in comparison to a CSW, and there were some areas where significantly better outcomes were identified.


Subject(s)
Interprofessional Relations , Patient Safety , Hospitals , Humans , Patient Care Team , Postoperative Complications/epidemiology , Retrospective Studies
6.
Dis Esophagus ; 35(7)2022 Jul 12.
Article in English | MEDLINE | ID: mdl-35178557

ABSTRACT

BACKGROUND: Delayed gastric emptying (DGE) occurs in up to 40% of patients after esophageal resection and prolongs recovery and hospital stay. Surgically pyloroplasty does not effectively prevent DGE. Recently published methods include injection of botulinum toxin (botox) in the pylorus and mechanical interventions as preoperative endoscopic dilatation of the pylorus. The aim of this study was to investigate the efficacy of those methods with respect to the newly published Consensus definition of DGE. METHODS: A systematic literature search using CENTRAL, Medline, and Web of Science was performed to identify studies that described pre- or intraoperative botox injection or mechanical stretching methods of the pylorus in patients undergoing esophageal resection. Frequency of DGE, anastomotic leakage rates, and length of hospital stay were analyzed. Outcome data were pooled as odd's ratio (OR) or mean difference using a random-effects model. Risk of bias was assessed using the Robins-I tool for non-randomized trials. RESULTS: Out of 391 articles seven retrospective studies described patients that underwent preventive botulinum toxin injection and four studies described preventive mechanical stretching of the pylorus. DGE was not affected by injection of botox (OR 0.87, 95% confidence interval [CI] 0.37-2.03, P = 0.75), whereas mechanical stretching resulted in significant reduction of DGE (OR 0.26, 95% CI 0.14-0.5, P < 0.0001). CONCLUSION: Mechanical stretching of the pylorus, but not injection of botox reduces DGE after esophageal cancer resection. A newly developed consensus definition should be used before the conduction of a large-scale randomized-controlled trial.


Subject(s)
Botulinum Toxins, Type A , Esophageal Neoplasms , Gastroparesis , Esophageal Neoplasms/surgery , Gastric Emptying , Gastroparesis/etiology , Gastroparesis/prevention & control , Humans , Postoperative Complications/prevention & control , Pylorus/surgery , Retrospective Studies
7.
HPB (Oxford) ; 24(3): 332-341, 2022 03.
Article in English | MEDLINE | ID: mdl-34294523

ABSTRACT

BACKGROUND: Surgical resection is the mainstay of potential cure for patients with pancreatic cancer, however, local recurrence is frequent. Previously, we have described an extended resection technique for pancreatoduodenectomy aiming at a radical resection of the nerve and lymphatic tissue between celiac artery, superior mesenteric artery and mesenteric-portal axis (TRIANGLE operation). Until now, data on postoperative outcome have not been reported, yet. METHODS: Patients who underwent either partial (PD) or total pancreatoduodenectomy (TP) applying the TRIANGLE procedure were identified. These cohorts were compared to matched historic cohorts with standard resections. RESULTS: Overall, 330 patients were analysed (PDTRIANGLE and PDSTANDARD, each n = 108; TPTRIANGLE and TPSTANDARD, each n = 57). More lymph nodes were harvested in TRIANGLE compared to standard resection (PD: 27.5 (21-35) versus 31.5 (24-40); P = 0.0187, TP: 33 (28-49) versus 44 (29-53); P = 0.3174) and the rate of tumour positive resections margins, R1(direct), dropped. Duration of operation was significantly longer and blood loss higher. Postoperative mortality and complications did not differ significantly. CONCLUSION: Pancreatoduodenectomy according to the TRIANGLE protocol can be performed without increased morbidity and mortality at a high-volume centre. Long-term survival and quality of life need to be investigated in prospective clinical trials with adequate sample size.


Subject(s)
Pancreatic Neoplasms , Quality of Life , Humans , Pancreas/surgery , Pancreatic Neoplasms/pathology , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy/adverse effects , Pancreaticoduodenectomy/methods , Prospective Studies
8.
Qual Life Res ; 30(9): 2429-2466, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34283381

ABSTRACT

PURPOSE: Patient-reported outcomes including health-related quality of life (HRQoL) are important oncological outcome measures. The validation of HRQoL instruments for patients with hepatocellular and cholangiocellular carcinoma is lacking. Furthermore, studies comparing different treatment options in respect to HRQoL are sparse. The objective of the systematic review and meta-analysis was, therefore, to identify all available HRQoL tools regarding primary liver cancer, to assess the methodological quality of these HRQoL instruments and to compare surgical, interventional and medical treatments with regard to HRQoL. METHODS: A systematic literature search was conducted in MEDLINE, the Cochrane library, PsycINFO, CINAHL and EMBASE. The methodological quality of all identified HRQoL instruments was performed according to the COnsensus-based Standards for the selection of health status Measurements INstruments (COSMIN) standard. Consequently, the quality of reporting of HRQoL data was assessed. Finally, wherever possible HRQoL data were extracted and quantitative analyses were performed. RESULTS: A total of 124 studies using 29 different HRQoL instruments were identified. After the methodological assessment, only 10 instruments fulfilled the psychometric criteria and could be included in subsequent analyses. However, quality of reporting of HRQoL data was insufficient, precluding meta-analyses for 9 instruments. CONCLUSION: Using a standardized methodological assessment, specific HRQoL instruments are recommended for use in patients with hepatocellular and cholangiocellular carcinoma. HRQoL data of patients undergoing treatment of primary liver cancers are sparse and reporting falls short of published standards. Meaningful comparison of established treatment options with regard to HRQoL was impossible indicating the need for future research.


Subject(s)
Liver Neoplasms , Quality of Life , Health Status , Humans , Liver Neoplasms/therapy , Patient Reported Outcome Measures , Psychometrics , Quality of Life/psychology
9.
J Gastrointest Surg ; 25(10): 2600-2609, 2021 10.
Article in English | MEDLINE | ID: mdl-33511544

ABSTRACT

BACKGROUND: Patients undergoing relaparotomy are generally underrepresented in trials, despite how common the procedure is in clinical practice. The aim of this trial was to determine standard of care and gain evidence of intra- and postoperative outcomes for patients undergoing relaparotomy compared to primary laparotomy. METHODS: In this single-center controlled clinical trial, adult patients scheduled for elective abdominal surgery via relaparotomy or primary laparotomy were consecutively screened for eligibility. The perioperative course was monitored prospectively in five study visits during hospital stay and one study visit 1 year after surgery. Intraoperative standards, short and long-term outcomes were statistically explored at a level of significance of 5%. RESULTS: A total of 131 patients with relaparotomy and 50 patients with primary laparotomy were analyzed. In the relaparotomy group, the access to the abdomen took longer (23.5 min vs. 8.8 min; p = < 0.001) and the peritoneal adhesion index was higher (10.8 vs. 0.4; p = < 0.001). Inadvertent enterotomies were more frequent in the relaparotomy group (relaparotomy 0.3 versus primary laparotomy: 0.0; p = 0.002). The overall comprehensive complication index and rates of surgical site infection and wound dehiscence with evisceration were not different between the two groups. At long-term follow-up, rates of incisional hernia did not differ (relaparotomy: n = 12/104 (11.5%); primary laparotomy: n = 7/35 (20.0%); p = 0.208). DISCUSSION: In this first prospective comparison of relaparotomy with primary laparotomy, inadvertent enterotomies were more frequent in the relaparotomy group. However, contrary to previous retrospective studies, the risk of complications and incisional hernias was not increased compared to primary laparotomy. TRIAL REGISTRATION: Deutsches Register Klinischer Studien ( www.germanctr.de ): DRKS00013001.


Subject(s)
Incisional Hernia , Laparotomy , Abdomen/surgery , Adult , Humans , Laparotomy/adverse effects , Prospective Studies , Standard of Care
10.
Langenbecks Arch Surg ; 405(4): 427-434, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32504207

ABSTRACT

BACKGROUND: Patients undergoing relaparotomy are generally underrepresented in clinical trials, despite how common the procedure is in clinical practice. Specifically, techniques for re-do abdominal wall closure have never been evaluated in a randomised-controlled trial. The aim of this trial was to identify the optimal abdominal wall closure technique in patients undergoing relaparotomy. METHODS: In this monocentric, randomised feasibility trial, patients scheduled for elective relaparotomy were randomised to abdominal wall closure with either the small stitches technique, using Monomax® 2-0, or the large stitches technique, using PDS II® 1 loop. Patients' postoperative courses were followed for 1 year after the index operation. Effectiveness and safety outcomes were compared at a level of significance of 5% between the two techniques. RESULTS: A total of 100 out of 131 patients (76.3%) were evenly randomised to the small stitches and large stitches groups. The time for abdominal wall closure did not differ between the two techniques (small stitches 27.5 ± 9.5 min versus large stitches 25.3 ± 12.4 min; p = 0.334). The overall comprehensive complication index was 14.4 ± 15.5 in the small stitches group and 19.9 ± 23.4 in the large stitches group (p = 0.168). Specifically, rates of surgical site infection (small stitches 30.0% versus large stitches 36.0%; p = 0.524) and burst abdomen (small stitches 4.0% versus large stitches 0.0%; p = 0.495) did not differ. After 1 year, incisional hernia rate was 7.5% in the small stitches group and 10.0% in the large stitches group (p > 0.999). DISCUSSION: Both abdominal wall closure techniques investigated in this trial were feasible in relaparotomy patients. This exploratory trial revealed no noticeable difference in the effectiveness or safety of the small stitches technique with Monomax® 2-0 versus the large stitches technique with PDS II® 1 loop. Therefore, surgeons should stay with their preferred suture technique in relaparotomy patients. TRIAL REGISTRATION: Deutsches Register Klinischer Studien ( www.germanctr.de ): DRKS00013001.


Subject(s)
Abdominal Wound Closure Techniques/adverse effects , Laparotomy/adverse effects , Postoperative Complications/epidemiology , Suture Techniques/adverse effects , Aged , Feasibility Studies , Female , Humans , Male , Middle Aged , Reoperation/adverse effects , Sutures , Treatment Outcome
11.
J Gastrointest Surg ; 24(6): 1375-1385, 2020 06.
Article in English | MEDLINE | ID: mdl-31228083

ABSTRACT

BACKGROUND: Physical exercise prehabilitation has been proposed to improve postoperative outcomes in patients undergoing major abdominal surgery. The aim of this systematic review was to investigate the effect of preoperative exercise training compared with standard care on postoperative outcomes in major abdominal surgery. METHODS: Randomized controlled trials (RCT) comparing prehabilitation with standard care were identified by a systematic literature search of MEDLINE and CENTRAL. Qualitative and quantitative analyses of perioperative outcome data were conducted. Meta-analyses were performed wherever possible and meaningful. RESULTS: A total of eight trials including 442 patients met the inclusion criteria. These trials investigated the effect of prehabilitation in patient cohorts undergoing major liver, colorectal, gastroesophageal, and general abdominal surgery. Quantitative analyses of all included trials showed a significant reduction in postoperative pulmonary complications (OR 0.37; 0.20 to 0.67; p = 0.001) as well as in postoperative overall morbidity (OR 0.52; 0.30 to 0.88; p = 0.01) in the prehabilitation group compared with standard care. The length of hospital stay showed no significant differences between the groups (MD - 0.58; - 1.28 to 0.13; p = 0.11). Risk of bias and methodological quality varied substantially among the trials, most of which were small single-center studies. CONCLUSION: Prehabilitation including a physical exercise intervention may lead to a reduction of postoperative pulmonary complications as well as less overall morbidity compared with standard care in patients undergoing major abdominal surgery. Further, well-designed RCT are needed to evaluate these potential positive effects in more detail and to identify suitable target populations. PROTOCOL REGISTRATION: PROSPERO 2017 CRD42017080366.


Subject(s)
Preoperative Care , Preoperative Exercise , Abdomen/surgery , Exercise , Humans , Length of Stay , Postoperative Complications/etiology , Postoperative Complications/prevention & control
12.
Trials ; 20(1): 738, 2019 Dec 16.
Article in English | MEDLINE | ID: mdl-31842966

ABSTRACT

BACKGROUND: Incisional hernias are among the most frequent complications following abdominal surgery and cause substantial morbidity, impaired health-related quality of life and costs. Despite improvements in abdominal wall closure techniques, the risk for developing an incisional hernia is reported to be between 10 and 30% following midline laparotomies. There have been two recent innovations with promising results to reduce hernia risks, namely the small stitches technique and the placement of a prophylactic mesh. So far, these two techniques have not been evaluated in combination. METHODS: The HULC trial is a multicentre, randomized controlled, observer- and patient-blinded surgical effectiveness trial with two parallel study groups. A total of 812 patients scheduled for elective abdominal surgery via a midline laparotomy will be randomized in 12 centres after informed consent. Patients will be randomly assigned to the control group receiving closure of the midline incision with a slowly absorbable monofilament suture in the small stitches technique or to the intervention group, who will receive a small stitches closure followed by augmentation with a light-weight polypropylene mesh in the onlay technique. The primary endpoint will be the occurrence of incisional hernias, as defined by the European Hernia Society, within 24 months after surgery. Further perioperative parameters, as well as patient-reported outcomes, will be analysed as secondary outcomes. DISCUSSION: The HULC trial will address the yet unanswered question of whether a combination of small stitched fascial closure and onlay mesh augmentation after elective midline laparotomies reduces the risk of incisional hernias. The HULC trial marks the logical and innovative next step in the development of a safe abdominal closure technique. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00017517. Registered on 24th June 2019.


Subject(s)
Abdominal Wound Closure Techniques/instrumentation , Hernia, Abdominal/prevention & control , Incisional Hernia/prevention & control , Surgical Mesh , Suture Techniques/instrumentation , Abdominal Wound Closure Techniques/adverse effects , Double-Blind Method , Germany , Hernia, Abdominal/diagnosis , Hernia, Abdominal/etiology , Humans , Incisional Hernia/diagnosis , Incisional Hernia/etiology , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , Suture Techniques/adverse effects , Time Factors , Treatment Outcome
13.
Langenbecks Arch Surg ; 404(3): 273-284, 2019 May.
Article in English | MEDLINE | ID: mdl-30824993

ABSTRACT

RATIONALE: Blinding reduces performance and detection bias in randomized controlled trials (RCT). There is evidence that lack of blinding leads to overestimation of treatment effects in pharmacological trials. Since surgical trials use interventions with a physical component, blinding is often complicated. The aim of this study was to analyze, in general and abdominal surgery RCT, the status of blinding, the potential for blinding, and the influence of blinding on outcomes. METHODS: A systematic search of the literature in CENTRAL, MEDLINE, and Web of Science was conducted to identify RCT with a surgical intervention, starting in 1996, the year when the first CONSORT statement was published. Information on general study characteristics and blinding methods was extracted. The presence or absence of blinding of the study contributors-patients, surgeons, data collectors, outcome assessors, and data analysts-was analyzed. The association of blinding with the trial outcome was investigated for every study contributor. RESULTS: Out of 29,119 articles, 378 RCT were included in the analysis. These investigated a total of 62,522 patients, of whom 15,025 were blinded (24.0%). Contributors could have been blinded in far more trials, as the potential for blinding measures ranged from 69% for outcome assessors to 98% for data analysts. If blinding of surgeons would have been possible but had not been performed, this was associated with more significant trial outcomes (OR 13.670; 95% CI 1.308 to 142.840; p = 0.0289). DISCUSSION: The potential of blinding, an important quality measure in surgical RCT, has not been exhausted. This study summarizes the existing evidence on blinding in surgical trials and gives evidence-based recommendations for the use of blinding in future surgical trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2015:CRD42015026837.


Subject(s)
Abdomen/surgery , Randomized Controlled Trials as Topic/standards , Research Design/standards , Surgical Procedures, Operative , Double-Blind Method , Humans , Single-Blind Method
14.
Langenbecks Arch Surg ; 404(1): 103-113, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30607534

ABSTRACT

PURPOSE: The aim of this systematic review and meta-analysis was to compare the oncological and perioperative outcomes of transhiatally extended gastrectomy (TEG) and thoracoabdominal esophagectomy (TAE) for therapy of adenocarcinomas of the esophagogastric junction (AEG) with focus on AEG type II, as the optimal approach for these tumors is still unclear. METHODS: MEDLINE, EMBASE, and the Cochrane Library (CENTRAL) were searched until July 24, 2018. Studies comparing TAE and TEG for surgical treatment of AEG type tumors have been included. Patient's baseline and perioperative data have been extracted and meta-analyses have been conducted for the outcomes: number of dissected lymph nodes, R0-resection rate, anastomotic leak rate, postoperative morbidity, and 30-day mortality. RESULTS: Of 6709 articles identified, 8 studies have been included for further analysis. One thousand thirty-four patients underwent TAE, and 1177 patients TEG. No differences were found between the approaches in regard to number of dissected lymph nodes (MD - 0.96; 95% CI - 3.07 to 1.15; p = 0.37), R0-resection rates (OR 0.97; 95% CI 0.57 to 1.63; p = 0.90), anastomotic leak rates (OR 1.13; 95% CI 0.69 to 1.86; p = 0.63), and 30-day mortality (OR 1.53; 95% CI 0.90 to 2.61; p = 0.11). However, a higher rate of postoperative morbidity was found after TAE (OR 1.55; 95% CI 1.12 to 2.14; p = 0.008). CONCLUSIONS: The optimal approach to surgical therapy of AEG II still remains unclear. This study identified a significantly higher rate of postoperative morbidity after TAE at comparable surgical outcomes. Due to major limitations concerning the quality of included studies, current data strongly mandates a properly designed randomized controlled trial to identify the optimal surgical approach for AEG type II tumors.


Subject(s)
Adenocarcinoma/surgery , Esophageal Neoplasms/surgery , Esophagectomy/methods , Esophagogastric Junction , Gastrectomy/methods , Postoperative Complications/epidemiology , Adenocarcinoma/mortality , Adenocarcinoma/pathology , Esophageal Neoplasms/mortality , Esophageal Neoplasms/pathology , Esophagectomy/adverse effects , Gastrectomy/adverse effects , Humans
15.
J Gastrointest Surg ; 22(8): 1418-1433, 2018 08.
Article in English | MEDLINE | ID: mdl-29589264

ABSTRACT

BACKGROUND: While several trials have compared laparoscopic to open surgery for colon cancer showing similar oncological results, oncological quality of laparoscopic versus open rectal resection is not well investigated. METHODS: A systematic literature search for randomized controlled trials was conducted in MEDLINE, the Cochrane Library, and Embase. Qualitative and quantitative meta-analyses of short-term (rate of complete resections, number of harvested lymph nodes, circumferential resection margin positivity) and long-term (recurrence, disease-free and overall survival) oncologic results were conducted. RESULTS: Fourteen randomized controlled trials were identified including 3528 patients. Patients in the open resection group had significantly more complete resections (OR 0.70; 95% CI 0.51-0.97; p = 0.03) and a higher number of resected lymph nodes (mean difference - 0.92; 95% CI - 1.08 to 0.75; p < 0.001). No differences were detected in the frequency of positive circumferential resection margins (OR 0.82; 95% CI 0.62-1.10; p = 0.18). Furthermore, no significant differences of long-term oncologic outcome parameters after 5 years including locoregional recurrence (OR 0.95; 95% CI 0.44-2.05; p = 0.89), disease-free survival (OR 1.16; 95% CI 0.84-1.58; p = 0.36), and overall survival (OR 1.04; 95% CI 0.76-1.41; p = 0.82) were found. Most trials exhibited a relevant risk of bias and several studies provided no information on the surgical expertise of the participating surgeons. CONCLUSION: Differences in oncologic outcome between laparoscopic and open rectal surgery for rectal cancer were detected for the complete resection rate and the number of resected lymph nodes in favor of the open approach. No statistically significant differences were found in oncologic long-term outcome parameters.


Subject(s)
Digestive System Surgical Procedures/methods , Laparoscopy , Neoplasm Recurrence, Local , Rectal Neoplasms/surgery , Disease-Free Survival , Humans , Lymph Node Excision , Neoplasm Recurrence, Local/pathology , Randomized Controlled Trials as Topic , Rectal Neoplasms/pathology , Survival Rate , Time Factors , Treatment Outcome
16.
Gastric Cancer ; 21(2): 303-314, 2018 Mar.
Article in English | MEDLINE | ID: mdl-28685209

ABSTRACT

BACKGROUND: The optimal surgical approach for adenocarcinoma directly at the esophagogastric junction (AEG II) is still under debate. This study aims to evaluate the differences between right thoracoabdominal esophagectomy (TAE) (Ivor-Lewis operation) and transhiatal extended gastrectomy (THG) for AEG II. METHODS: From a prospective database, 242 patients with AEG II (TAE, n = 56; THG, n = 186) were included and analyzed according to characteristics and perioperative morbidity and mortality and overall survival (chi-square, Mann-Whitney U, log-rank, Cox regression). RESULTS: Groups were comparable at baseline with exception of age. Patients older than 70 years were more frequently resected by THG (p = 0.003). No differences in perioperative morbidity (p = 0.197) and mortality (p = 0.711) were observed, including anastomotic leakages (p = 0.625) and pulmonary complications (p = 0.494). There was no significant difference in R0 resection (p = 0.719) and number of resected lymph nodes (p = 0.202). Overall median survival was 38.4 months. Survival after TAE was significantly longer than after THG (median OS not reached versus 33.6 months, p = 0.02). Multivariate analysis revealed pN-category (p < 0.001) and type of surgery (p = 0.017) as independent prognostic factors. The type of surgery was confirmed as prognostic factor in locally advanced AEG II (cT 3/4 or cN1), but not in cT1/2 and cN0 patients. CONCLUSIONS: Our single-center experience suggests that patients with (locally advanced) AEG II tumors may benefit from TAE compared to THG. For further evaluation, a randomized trial would be necessary.


Subject(s)
Adenocarcinoma/surgery , Esophagectomy/methods , Esophagogastric Junction/surgery , Gastrectomy/methods , Adenocarcinoma/mortality , Adult , Aged , Esophageal Neoplasms/mortality , Esophageal Neoplasms/surgery , Esophagectomy/mortality , Female , Gastrectomy/mortality , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Proportional Hazards Models , Stomach Neoplasms/mortality , Stomach Neoplasms/surgery
17.
World J Surg ; 41(11): 2746-2757, 2017 11.
Article in English | MEDLINE | ID: mdl-28634842

ABSTRACT

BACKGROUND: Adrenalectomy can be performed via open and various minimally invasive approaches. The aim of this systematic review was to summarize the current evidence on surgical techniques of adrenalectomy. METHODS: Systematic literature searches (MEDLINE, EMBASE, Web of Science, Cochrane Library) were conducted to identify randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing at least two surgical procedures for adrenalectomy. Statistical analyses were performed, and meta-analyses were conducted. Furthermore, an indirect comparison of RCTs and a network meta-analysis of CCTs were carried out for each outcome. RESULTS: Twenty-six trials (1710 patients) were included. Postoperative complication rates did not show differences for open and minimally invasive techniques. Operation time was significantly shorter for open adrenalectomy than for the robotic approach (p < 0.001). No differences were found between laparoscopic and robotic approaches. Network meta-analysis showed open adrenalectomy to be the fastest technique. Blood loss was significantly reduced in the robotic arm compared with open and laparoscopic adrenalectomy (p = 0.01). Length of hospital stay (LOS) was significantly lower after conventional laparoscopy than open adrenalectomy in CCTs (p < 0.001). Furthermore, both retroperitoneoscopic (p < 0.001) and robotic access (p < 0.001) led to another significant reduction of LOS compared with conventional laparoscopy. This difference was not consistent in RCTs. Network meta-analysis revealed the lowest LOS after retroperitoneoscopic adrenalectomy. CONCLUSION: Minimally invasive adrenalectomy is safe and should be preferred over open adrenalectomy due to shorter LOS, lower blood loss, and equivalent complication rates. The retroperitoneoscopic access features the shortest LOS and operating time. Further high-quality RCTs are warranted, especially to compare the posterior retroperitoneoscopic and the transperitoneal robotic approach.


Subject(s)
Adrenalectomy/methods , Laparoscopy , Robotic Surgical Procedures , Adrenalectomy/adverse effects , Blood Loss, Surgical , Humans , Laparoscopy/adverse effects , Laparoscopy/methods , Length of Stay , Network Meta-Analysis , Operative Time , Randomized Controlled Trials as Topic , Robotic Surgical Procedures/adverse effects , Robotic Surgical Procedures/methods
18.
J Gastrointest Surg ; 21(9): 1523-1532, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28439770

ABSTRACT

BACKGROUND: Anastomotic leakage is one of the most severe complications following esophageal resection. Among other strategies, gastric ischemic preconditioning has been proposed to improve anastomotic integrity. The aim of this systematic review is to investigate whether gastric preconditioning has influence on peri- or postoperative outcomes after esophageal resection. METHODS: A systematic literature search was performed to identify studies comparing gastric preconditioning with non-preconditioned patients for any indication of esophageal resection. Random-effects meta-analyses were conducted for main outcomes. RESULTS: Gastric preconditioning did not reduce anastomotic leakages (OR 0.76; 95%-CI 0.51 to 1.13; p = 0.18), anastomotic strictures (OR 1.10; 95%-CI 0.58 to 2.10; p = 0.76;), major complications (OR 1.14; 95%-CI 0.60 to 2.14; p = 0.69), or in-hospital mortality (OR 0.62; 95%-CI 0.28 to 1.40; p = 0.25). However, preconditioning reduced the rate of severe leaks requiring reoperation (OR 0.20; 95%-CI 0.08 to 0.53; p = 0.001). Increasing the period between preconditioning and esophageal resection over 2 weeks did not reduce anastomotic leakage compared to shorter waiting times (OR 0.65; 95%-CI 0.38 to 1.13; p = 0.13). CONCLUSION: With current evidence, gastric preconditioning does not seem to reduce overall rates of anastomotic leakage after esophageal resection but seems to reduce severity of leakages.


Subject(s)
Anastomotic Leak/etiology , Esophageal Neoplasms/surgery , Esophagectomy/adverse effects , Esophagus/surgery , Ischemic Preconditioning , Stomach/blood supply , Anastomosis, Surgical/adverse effects , Anastomotic Leak/surgery , Hospital Mortality , Humans , Reoperation , Stomach/surgery
19.
Transpl Int ; 30(6): 543-555, 2017 Jun.
Article in English | MEDLINE | ID: mdl-28295643

ABSTRACT

Lymphocele formation after kidney transplantation is a frequent complication which causes pain, secondary graft loss, rehospitalizations and reoperations. Therefore, prophylaxis of lymphocele formation is of utmost importance. To assess the effectiveness of peritoneal fenestration in renal transplantation to prevent lymphocele development. A systematic literature search was conducted combined with hand-searches on lymphocele prevention following renal transplantation using peritoneal fenestration. A qualitative and quantitative analysis of included trials was conducted. We identified three trials including 414 patients and 437 transplantations which studied peritoneal fenestration. Only one randomized controlled trial was identified. Critical appraisal uncovered a number of methodological flaws, predominantly in the nonrandomized studies. Most importantly endpoint definitions varied among trials, selection bias was high and interventions and follow-up were not standardized. Meta-analysis of the included trials showed a significant reduction of clinically symptomatic lymphoceles (OR: 0.23, 95% CI: 0.09-0.64, P = 0.005) and overall postoperative fluid collections (OR: 0.49, 95% CI: 0.28-0.88, P = 0.02) without a significant increase in other surgical complications. Although peritoneal fenestration is a promising technique to reduce lymphocele formation, only few studies have investigated this technique so far. Given the low methodological quality of included trials, more studies are necessary to evaluate the effectiveness and the risks and benefits of this technique.


Subject(s)
Kidney Transplantation/adverse effects , Lymphocele/prevention & control , Peritoneum/surgery , Postoperative Complications/prevention & control , Clinical Trials as Topic , Drainage/methods , Humans , Kidney Transplantation/methods , Laparoscopy/methods , Lymphocele/etiology , Lymphocele/therapy , Postoperative Complications/etiology , Postoperative Complications/therapy , Treatment Outcome
20.
Ann Med Surg (Lond) ; 7: 87-91, 2016 May.
Article in English | MEDLINE | ID: mdl-27144004

ABSTRACT

INTRODUCTION: Esophageal foreign bodies are an important and serious cause of morbidity and mortality in both children and adults. Due to the possibility of serious complications, i.e. perforation, necrosis, mediastinitis, and fistulation, rapid and accurate diagnostic measures with subsequent therapy are necessary. CASE REPORT: We are reporting a case of a 55-year-old, mentally impaired patient that has swallowed a foreign body, which subsequently became lodged in his esophagus. Due to the fact that endoscopic removal was not possible and there was a high risk of complications such as esophageal perforation or mediastinitis in this case, we performed cervical esophagotomy and successfully extracted the foreign body. The patient showed an uneventful postoperative process and could be discharged on Day 11 after the operation. COMPREHENSIVE REVIEW: Furthermore, we performed a systematic review of the literature to identify all studies that described a surgical approach through esophagotomy in cases of foreign body ingestion and found 11 publications describing the cases of 29 patients. These studies reported an overall complication rate of 17.2% and a mortality rate of 0%. CONCLUSION: Our findings suggest that esophagotomy could be a viable approach for the extraction of foreign bodies especially in some cases when endoscopic removal was not successful and the risk of esophageal perforation is high.

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