Postoperative drainage management and wound complications following resection of lower limb soft tissue tumors: a retrospective cohort study.

PURPOSE: Postoperative wound complications are common in patients undergoing resection of lower extremity soft tissue tumors. Postoperative drainage therapy ensures adequate wound healing but may delay or complicate it. The aim of this study is to evaluate the incidence of postoperative wound complications and delayed or prolonged drainage treatment and to propose a standardized definition and severity grading of complex postoperative courses. METHODS: A monocentric retrospective analysis of 80 patients who had undergone primary resection of lower extremity soft tissue tumors was performed. A new classification was developed, which takes into account postoperative drainage characteristics and wound complications. Based on this classification, risk factors and the prognostic value of daily drainage volumes were evaluated. RESULTS: According to this new definition, regular postoperative course grade 0 (no wound complication and timely drainage removal) occurred in 26 patients (32.5%), grade A (minor wound complications or delayed drainage removal) in 12 (15.0%), grade B (major wound complication or prolonged drainage therapy) in 31 (38.8%), and grade C (reoperation) in 11 (13.7%) patients. Tumor-specific characteristics, such as tumor size (p = 0.0004), proximal tumor location (p = 0.0484), and tumor depth (p = 0.0138) were identified as risk factors for complex postoperative courses (grades B and C). Drainage volume on postoperative day 4 was a suitable predictor for complex courses (cutoff of 70 ml/d). CONCLUSION: The proposed definition incorporates wound complications and drainage management while also being clinically relevant and easy to apply. It may serve as a standardized endpoint for assessing the postoperative course after resection of lower extremity soft tissue tumors.

Flexible endoscopy is enough diagnostic prior to loop ileostomy reversal.

PURPOSE: This study investigates whether contrast enema (CE) and flexible endoscopy (FE) should be performed routinely after low anterior resection (LAR) before ileostomy reversal. Additionally, the impact of previous anastomotic leakage (AL) on diagnostic test accuracy (DTA) was assessed. METHODS: This is a retrospective analysis of prospectively collected tertiary care data of two centers. Consecutive rectal cancer patients undergoing LAR with loop ileostomy formation were included. Before ileostomy reversal, all patients were assessed by CE and FE. DTA of FE and CE for asymptomatic AL in patients who had previously suffered from clinically relevant AL (group 1) compared with those without apparent AL after LAR (group 0) were assessed separately. RESULTS: Two hundred ninety-three patients were included in the analysis, 86 in group 1 and 207 in group 0. Overall sensitivity for detection of asymptomatic AL was 76% (FE) and 60% (CE). Specificity was 100% for both tests. DTA of FE was equal or superior to CE in all subgroups. Prevalence of asymptomatic AL at the time of testing was 1.4% in group 0 and 25.6% in group 1. CONCLUSION: Flexible endoscopy is the more accurate diagnostic test for the detection of asymptomatic anastomotic leaks prior to ileostomy reversal. Contrast enema showed no gain of information. In the group without complications after the initial rectal resection, 104 must be tested to find one leak prior to reversal. In those patients, routine diagnostic testing additional to digital rectal examination may be questioned.

Incisional hernia rate after ileostomy closure in lateral pararectal stoma versus transrectal stoma placement: follow-up of the randomized PATRASTOM trial.

AIM: Because damage to the rectus abdominis muscle during ileostomy placement and reversal might be a risk factor for the development of stoma-site incisional hernia (SSIH), we hypothesized that positioning of the stoma lateral to the rectus abdominis muscle might prevent SSIH. METHOD: To investigate whether a lateral pararectal stoma position lowers the incidence of SSIH in comparison with a transrectal position, a follow-up study of the PATRASTOM trial, which had randomized stoma placement (lateral pararectal versus transrectal), was conducted. All former participants were invited simultaneously for a follow-up visit in September 2016, 2 years after database closure of the PATRASTOM trial. For patients who were not able to attend the follow-up, the electronic chart as well as MRI/CT scans were reviewed with regard to the presence of SSIH. RESULTS: Follow-up - either clinical or radiological - was available for 47 of the 60 PATRASTOM participants. The median duration of follow-up was 3.4 years (interquartile range 3.0-4.1 years). SSIH occurred in 3 of 23 patients (13.0%) in the lateral pararectal group compared with 7 of 24 patients (29.2%) in the transrectal group (P = 0.287). Four of the 10 patients diagnosed with SSIH had already undergone or were scheduled for hernia repair. Of the patient and procedure characteristics which may have an impact on the development of incisional hernia none was a significant risk factor for SSIH. CONCLUSION: In the present follow-up study, no difference in the incidence of SSIH was found between lateral pararectal and transrectal stoma construction in an elective setting.

Laparoscopic ventral pouch pexy with acellular dermal matrix (ADM)-a novel technique for the treatment of full-thickness pouch prolapse after restorative proctocolectomy and j-pouch.

PURPOSE: Ileal pouch prolapse is a rare complication after j-pouch formation with an incidence of about 0.3%. However, if a pouch prolapse occurs, it can be a debilitating complication for the patient. Full-thickness pouch prolapse usually warrants surgical repair as reported by Sagar and Pemberton (Br J Surg 99(4):454-468, 2012) and Sherman et al. (Inflamm Bowel Dis 20(9):1678-1685, 2014). This report presents our first experience with laparoscopic ventral pouch pexy with acellular dermal matrix (ADM). METHODS: With the patient in the French position, four trocars were positioned: a camera port at the level of the umbilicus, two 5-mm trocars in the right lower quadrant, and a third 5-mm trocar in the left lower quadrant. The j-pouch was mobilized ventrally and laterally to the level of the sphincter. A 4 × 16-cm piece of ADM (EPIFLEX®, POLYTECH Health & Aesthetics, Dieburg, Germany) was sutured to the levators on both sides and to the ventral pouch directly cranial of the sphincter. In the next step, the ADM was attached to the promontory. Subsequently, further sutures were placed to attach the pouch to the ADM. Finally, the ADM was sewn to the cranial vaginal pole. RESULTS: Operating time was 249 min. The postoperative course was uneventful except for a higher stool frequency which could be managed conservatively. The patient was discharged on POD 9. At the latest follow-up (12 months after surgery), the patient was still symptom free without any sign of recurrence. CONCLUSIONS: Laparoscopic ventral pouch pexy with ADM performed by a surgeon experienced in laparoscopic pouch surgery is a safe and effective treatment option in patients with pouch prolapse.

Hereditary angioedema with a mutation in the plasminogen gene.

BACKGROUND: Hereditary angioedema (HAE) with normal C1-INH (HAEnCI) may be linked to specific mutations in the coagulation factor 12 (FXII) gene (HAE-FXII) or functional mutations in other genes that are still unknown. We sought to identify and characterize a hitherto unknown type of HAE with normal C1-INH and without mutation in the F12 gene. METHODS: The study comprised analysis of whole-exome sequencing, Sanger sequencing, and clinical data of patients. RESULTS: We detected a mutation in the plasminogen (PLG) gene in patients with HAEnCI. The mutation c.988A>G was located in exon 9 leading to the missense mutation p.Lys330Glu (K330E) in the kringle 3 domain of the PLG protein. The mutation was identified by next-generation sequencing in 14 patients with HAEnCI belonging to 4 of 7 families. Family studies revealed that this type of HAE was transmitted as an autosomal dominant trait. The PLG gene mutation was present in all studied symptomatic patients and was also found in 9 of 38 index patients from 38 further families with HAEnCI. Most patients had swelling of face/lips (78.3%) and tongue (78.3%). A total of 331 of all 3.795 tongue swellings (8.7%) were associated with dyspnea, voice changes, and imminent asphyxiation. Two women died by asphyxiation due to a tongue swelling. CONCLUSIONS: Hereditary angioedema with a mutation in the PLG gene is a novel type of HAE. It is associated with a high risk of tongue swellings.

[Quality indicators for colon cancer surgery : Evidence-based development of a set of indicators for the outcome quality]. / Qualitätsindikatoren für die onkologische Kolonchirurgie : Evidenzbasierte Entwicklung eines Indikatorensets für die Ergebnisqualität.

BACKGROUND: Quality assessment in surgery is gaining in importance. Although sporadic recommendations for quality indicators (QI) in oncological colon surgery can be found in the literature, these are usually not systematically derived from a solid evidence base. Moreover, reference ranges for QI are unknown. OBJECTIVE: The aim of this initiative was the development of evidence-based QI for oncological colon resections by an expert panel invited by the German Society of General and Visceral Surgery (DGAV). Reference ranges from the literature and reference values from the Study, Documentation, and Quality Center (StuDoQ)|Colon Cancer Register were compared in order to deduce recommendations which are tailored to the German healthcare system. RESULTS: Based on the most recent scientific evidence and agreed by expert consensus, five QI for oncological colon surgery were defined and evaluated according to the QUALIFY tool. Mortality, MTL30 (mortality, transfer to another acute care hospital, or length of stay ≥30 days), anastomotic leakage requiring reintervention, surgical site infections necessitating reopening of the wound and ≥12 lymph nodes in the specimen qualified as QI owing to their relevance, scientific nature, and practicability. Based on the results of the systematic literature search and the statistical analysis of the StuDoQ|Colon Cancer Register, preliminary reference values are proposed for each QI. CONCLUSION: The presented set of QI seems appropriate for quality assessment of oncological colon surgery in the context of the German healthcare system. The validity of the QI and the reference values must be reviewed within the framework of their implementation. The StuDoQ|Colon Cancer Register provides a suitable infrastructure for collecting clinical data for quality assessment and risk adjustment.

Preoperative hypoalbuminemia is an independent risk factor for increased high-grade morbidity after elective rectal cancer resection.

PURPOSE: This study investigated the association of preoperative hypoalbuminemia and postoperative complications after elective resection for rectal cancer. METHODS: From September 2009 to December 2014, all patients who underwent elective rectal resection for adenocarcinoma of the rectum were identified using a prospective colorectal cancer database. Hypoalbuminemia was defined as a serum albumin < 35 g/L. Characteristics and outcomes of hypoalbuminemic patients were compared to those of patients with normal albumin levels. Potential risk factors for postoperative major morbidity, defined as Clavien-Dindo ≥ grade 3, were analyzed by both univariate and multivariate analyses. RESULTS: Three hundred seventy patients met the inclusion criteria. Hypoalbuminemic patients (67/370 (18%)) were significantly older and had more advanced tumor stages and more comorbidities (more ASA III, higher percentage of diabetics). Furthermore, they were more likely to undergo abdominoperineal resection instead of low anterior resection and less likely to be operated laparoscopically. On univariate analysis, a higher BMI, advanced tumor stages, diabetes, open procedures, pre- and postoperative hypoalbuminemia, a higher decrease in albumin (∆ preop-postop), and conversion were significantly associated with postoperative high-grade morbidity. On multivariate analysis, diabetes, advanced tumor stages, a higher decrease in the albumin level, as well as preoperative hypoalbuminemia turned out to be independent risk factors for postoperative high-grade morbidity. CONCLUSIONS: Hypoalbuminemia is an independent risk factor for postoperative high-grade morbidity. As a low-cost and easy accessible test, serum albumin should be used as a prognostic tool to detect patients at risk for adverse outcomes after resection for rectal cancer.

[MTL30 as surrogate parameter for quality of surgically treated diseases : Establishment based on the StuDoQ register of the German Society for General and Visceral Surgery]. / MTL30 als Surrogatparameter der Behandlungsqualität chirurgischer Erkrankungen : Etablierung anhand der StuDoQ-Register der Deutschen Gesellschaft für Allgemein- und Viszeralchirurgie.

From a sociopolitical aspect there is increasing interest in the quality of healthcare. In this context valid, reproducible, comparable and risk-adjustable markers that are easily identified have become crucial for consistent documentation of quality. We recommend MTL30 (mortality, transfer, length of stay) as one of these markers to consistently measure the quality of large visceral surgical interventions. The MTL30 subsumes a number of known markers that may help to predict postoperative complications. The MTL30 is considered to be fulfilled when a patient on the 30th day following surgery, a) has died b) is still in the hospital or c) has been transferred to another acute care hospital. The evaluation of the StuDoQ register of the German Society for General and Visceral Surgery (DGAV) shows that MTL30 occurs significantly more often than any of the individual parameters. The correlation between MTL30 and other patient-specific risk factors, e.g. American Society of Anesthesiologists classification (ASA), age, etc. enables a risk adjustment.

[The technique of restorative proctocolectomy with ileal J­pouch : Standards and controversies]. / Technik der Proktokolektomie mit ileoanalem Pouch : Standards und Kontroverses.

BACKGROUND: Restorative proctocolectomy (RPC) is the standard of care in the case of medically refractory disease and in neoplasia in ulcerative colitis (UC). OBJECTIVES: This review aims at providing an overview of the current evidence on standards, innovations, and controversies with regard to the surgical technique of RPC. RESULTS: RPC is the standard of care in the surgical management of UC refractory to medical treatment and in neoplasia. Due to its simplicity and good functional outcomes, the J­pouch is the most used pouch design. RPC is usually performed as a two-stage procedure. In the presence of risk factors, a three-stage procedure should be performed. The technically more demanding mucosectomy and hand sewn anastomosis does not seem to result in a better oncologic outcome than stapled anastomosis. Functional results appear marginally better after stapled anastomosis, but the rectal cuff should not exceed 2 cm in this reconstruction. The laparoscopic approach is at least as good as the open approach. For the new, innovative surgical approaches such as robotics and transanal surgery, only feasibility but no advantages have yet been demonstrated. CONCLUSION: The evidence in regard to controversial points remains limited.

Resection enterostomy versus Hartmann's procedure for emergency colonic resections.

BACKGROUND: If a primary anastomosis is considered too risky after emergency colon resection either a resection enterostomy or an end stoma with closure of the distal bowel (Hartmann's procedure) is possible. This study analyzes the rate of restoration of intestinal continuity and other surgical outcomes after resection enterostomy placement versus Hartmann's procedure for emergency colon resections. METHODS: All patients who underwent emergency colorectal resections between August 2009 and June 2014 at the University Medical Center Mannheim were reviewed in regard to therapeutic approach, rate of restoration of bowel continuity, and surgical morbidity after the primary operation and after reversal surgery. RESULTS: Fifty-five patients in whom both studied interventions would have been technically feasible were further analyzed. The rate of revisional surgery was significantly higher in the resection enterostomy cohort after the primary operation. There were no significant differences regarding morbidity, mortality, and the rate of restoration of intestinal continuity. Overall, bowel continuity could be restored in 63% (29/46) of the surviving patients. The median time of surgery of the initial as well as of the reversal surgery was significantly longer in the Hartmann's group. Five of 13 patients underwent protective ileostomy placement in the Hartmann's group at the time of the reversal (vs. none in the resection enterostomy group). CONCLUSIONS: The bowel continuity can be restored in the majority of patients after emergency colonic resection. Conclusive evidence which surgical option should be preferred when a primary anastomosis is considered too risky-Hartmann's procedure or resection enterostomy-is still lacking.

Treatment for hereditary angioedema with normal C1-INH and specific mutations in the F12 gene (HAE-FXII).

Hereditary angioedema with normal C1 esterase inhibitor and mutations in the F12 gene (HAE-FXII) is associated with skin swellings, abdominal pain attacks, and the risk of asphyxiation due to upper airway obstruction. It occurs nearly exclusively in women. We report our experience treating HAE-FXII with discontinuation of potential trigger factors and drug therapies. The study included 72 patients with HAE-FXII. Potential triggers included estrogen-containing oral contraceptives (eOC), hormonal replacement therapy, or angiotensin-converting enzyme inhibitors. Drug treatment comprised plasma-derived C1 inhibitor (pdC1-INH) for acute swelling attacks and progestins, tranexamic acid, and danazol for the prevention of attacks. Discontinuation of eOC was effective in 25 (89.3%) of 28 women and led to a reduction in the number of attacks (about 90%). After ending hormonal replacement therapy, three of eight women became symptom-free. Three women with exacerbation of HAE-FXII during intake of quinapril or enalapril had no further HAE-FXII attacks after discontinuation of those drugs. Eleven women were treated with pdC1-INH for 143 facial attacks. The duration of the treated facial attacks (mean: 26.6 h; SD: 10.1 h) was significantly shorter than that of the previous 88 untreated facial attacks in the same women (mean: 64.1 h; SD: 28.0 h; P < 0.01). The mean reduction in attack frequency was 99.8% under progestins after discontinuing eOC (16 women), 93.8% under tranexamic acid (four women), and 100% under danazol (three women). For patients with HAE-FXII, various treatment options are available which completely or at least partially reduce the number or duration of attacks.

Abdominoperineal resection and perineal wound healing in recurrent, persistent, or primary anal carcinoma.

PURPOSE: Chemoradiotherapy is the standard treatment for squamous cell anal cancer. Salvage abdominoperineal resection (APR) is usually reserved for patients presenting with recurrent or persistent disease. Aim of our study was to review the outcomes of salvage surgery and perineal wound healing with or without a vertical rectus abdominis myocutaneous (VRAM) flap in a single institution over a 6-year period. METHODS: Data of all patients with biopsy-proven squamous cell anal cancer treated with chemoradiation at the University Medical Center Mannheim were recorded prospectively. Medical records of all patients who underwent salvage surgery for anal carcinoma between June 2008 and June 2014 were reviewed with regard to surgical and oncological outcomes. RESULTS: One hundred twenty-four patients received chemoradiation with a 5-year overall survival of 79 %. Seventeen patients required (salvage) APR for recurrent (n = 8), persistent (n = 7), or primary anal carcinoma (n = 2). Median overall survival was 33.4 months. Median duration until completion of perineal wound healing was shorter in the VRAM group (17 vs. 24.5 weeks; p = 0.0541). CONCLUSIONS: Salvage APR has a reasonable chance of long-time survival. Perineal reconstruction with a VRAM flap may reduce the duration until completion of perineal wound healing.

A pilot single-centre randomized trial assessing the safety and efficacy of lateral pararectus abdominis compared with transrectus abdominis muscle stoma placement in patients with temporary loop ileostomies: the PATRASTOM trial.

AIM: Transrectal stoma placement is considered the standard technique for positioning a stoma. A prospective series using a novel method of lateral pararectal stoma placement recently revealed a remarkably low stoma herniation rate. A randomized trial was conducted to compare the lateral pararectal with the transrectal stoma position with regard to parastomal herniation, stoma-related morbidity and quality of life. METHOD: Adult patients undergoing elective placement of a temporary loop ileostomy were eligible for inclusion. Patients were intra-operatively randomized to undergo either a lateral pararectal or a transrectal ileostomy. The primary end-point was the rate of parastomal herniation. Secondary end-points included other stoma-related complications and quality of life. Sample size calculation resulted in 54 patients having to be analysed to detect a difference of parastomal herniation of 30% with an 80% power and a 5% significance level. The trial was registered with the German Clinical Trials Register (registration number DRKS00003534). RESULTS: Between April 2012 and April 2014, 30 patients were randomized to each group. The incidence of parastomal herniation did not differ between the lateral pararectal (5 of 27) and the transrectal group (4 of 29; P = 0.725). There was also no significant difference regarding other stoma-related complications and the EORTC quality of life scales C30 and CR29. CONCLUSION: The incidence of parastomal herniation and other stoma-related complications did not differ between the groups. However, due to the limited sample size a small difference in favour of one of the two stoma placement techniques cannot be entirely ruled out.

Hereditary angioedema with normal C1-INH with versus without specific F12 gene mutations.

BACKGROUND: Hereditary angioedema with normal C1-INH may be linked to specific mutations in the coagulation factor 12 (FXII) gene (HAE-FXII) or mutations in genes that are still unknown (HAE-unknown). To assess the differences in transmission and inheritance, clinical features, and laboratory parameters between patients with HAE-FXII and HAE-unknown. METHODS: Sixty-nine patients with HAE-FXII from 23 unrelated families and 196 patients with HAE-unknown from 65 unrelated families were studied. RESULTS: Both HAE-FXII and HAE-unknown are inherited as autosomal-dominant traits with incomplete penetrance. The male to female ratio was 1 : 68 in HAE-FXII and 1 : 6.3 in HAE-unknown. The maternal to paternal transmission ratio was 35 : 14 for HAE-FXII and 109 : 12 for HAE-unknown. Mean age at onset of clinical symptoms was 20.3 years in patients with HAE-FXII and 29.6 years in patients with HAE-unknown. The incidence of asphyxiation due to angioedema was similar for HAE-FXII and HAE-unknown. Oral contraceptives and pregnancies had a significantly higher impact on HAE-FXII than on HAE-unknown. Slightly decreased C1-INH activity and C4 concentration were observed in more patients with HAE-FXII than HAE-unknown. Tests for FXI and FXII activity, plasminogen activator inhibitor 1, and activated partial thromboplastin time showed variability but no significant differences between the groups. No abnormalities were found for C1-INH protein, C1q, alpha2-macroglobulin, antithrombin III, and angiotensin-converting enzyme. In families with HAE-FXII, the number of female offspring with F12 mutations was significantly increased and that of male offspring was significantly decreased. CONCLUSIONS: HAE-FXII and HAE-unknown differ in various respects, including gender distribution, genetics, symptoms, and estrogen impact.

Suicidality and its relationship with depression, alcohol disorders and childhood experiences of violence: results from the ESEMeD study.

BACKGROUND: Suicidality constitutes a major health concern in many countries. The aim of the present paper was to analyse 10 of its risk factors and their interdependence. METHODS: Data on suicidality, mental disorders and experience of childhood violence was collected from 8796 respondents in the European Study of the Epidemiology of Mental Disorders (ESEMeD). The CIDI was used to assess mental disorders. Individuals were randomly divided into two subgroups. In one, a Graphical Markov model to predict suicidality was constructed, in the second, predictors were cross-validated. RESULTS: Lifetime suicidality was predicted mainly by lifetime depression and early experiences of violence, with a pseudo R-square of 12.8%. In addition, alcohol disorders predicted suicidality, but played a minor role compared with the other risk factors in this sample. CONCLUSION: In addition to depression, early experience of violence constitutes an important risk factor of suicidality. LIMITATIONS: This is a cross-sectional and retrospective study assessing risk factors for suicidality, not for suicide itself.