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1.
Dis Colon Rectum ; 61(2): 172-178, 2018 Feb.
Article in English | MEDLINE | ID: mdl-29337771

ABSTRACT

BACKGROUND: The management of the rectal wall defect after local excision of rectal neoplasms remains controversial, and the existing data are equivocal. OBJECTIVE: This study aimed to determine the effect of open versus closed defects on postoperative outcomes after local excision of rectal neoplasms. DESIGN: Data from 3 institutions were analyzed. Propensity score matching was performed in one-to-one fashion to create a balanced cohort comparing open and closed defects. SETTINGS: This study was conducted at high-volume specialist referral hospitals. PATIENTS: Adult patients undergoing local excision via transanal endoscopic surgery from 2004 to 2016 were included. Patients were assigned to open- and closed-defect groups, and further stratified by full- or partial-thickness excision. INTERVENTION: Closure of the rectal wall defect was performed at the surgeon's discretion. MAIN OUTCOME MEASURES: The primary outcome measured was the incidence of 30-day complications. RESULTS: A total of 991 patients were eligible (593 full-thickness excision with 114 open and 479 closed, and 398 partial-thickness excision with 263 open and 135 closed). After matching, balanced cohorts consisting of 220 patients with full-thickness excision and 210 patients with partial-thickness excision were created. Operative time was similar for open and closed defects for both full-and partial-thickness excision. The incidence of 30-day complications was similar for open and closed defects after full- (15% vs. 12%, p = 0.432) and partial-thickness excision (7% vs 5%, p = 0.552). The total number of complications was also similar after full- or partial-thickness excision. Patients undergoing full-thickness excision with open defects had a higher incidence of clinically significant bleeding complications (9% vs 3%, p = 0.045). LIMITATIONS: Data were obtained from 3 institutions with different equipment and perioperative management over a long time period. CONCLUSIONS: There was no difference in overall complications between open and closed defects for patients undergoing local excision of rectal neoplasms, but there may be more bleeding complications in open defects after full-thickness excision. A selective approach to defect closure may be appropriate. See Video Abstract at http://links.lww.com/DCR/A470.


Subject(s)
Rectal Neoplasms/surgery , Rectum/abnormalities , Rectum/surgery , Transanal Endoscopic Surgery/methods , Aged , Female , Humans , Incidence , Male , Margins of Excision , Middle Aged , Minimally Invasive Surgical Procedures/adverse effects , Minimally Invasive Surgical Procedures/methods , Operative Time , Postoperative Complications/epidemiology , Propensity Score , Rectal Neoplasms/epidemiology , Rectal Neoplasms/pathology , Rectum/pathology , Transanal Endoscopic Microsurgery/adverse effects , Transanal Endoscopic Microsurgery/methods , Treatment Outcome , Wound Closure Techniques
2.
Dis Colon Rectum ; 60(9): 928-935, 2017 Sep.
Article in English | MEDLINE | ID: mdl-28796731

ABSTRACT

BACKGROUND: There are no data comparing the quality of local excision of rectal neoplasms using transanal endoscopic microsurgery and transanal minimally invasive surgery. OBJECTIVE: The purpose of this study was to compare the incidence of tumor fragmentation and positive margins for patients undergoing local excision of benign and malignant rectal neoplasms using transanal endoscopic microsurgery versus transanal minimally invasive surgery. DESIGN: This was a multi-institutional cohort study using coarsened exact matching. SETTINGS: The study was conducted at high-volume tertiary institutions with specialist colorectal surgeons. PATIENTS: Patients undergoing full-thickness local excision for benign and malignant rectal neoplasms were included. INTERVENTIONS: Transanal endoscopic microsurgery and transanal minimally invasive surgery were the included interventions. MAIN OUTCOME MEASURES: The incidence of poor quality excision (composite measure including tumor fragmentation and/or positive resection margin) was measured. RESULTS: The matched cohort consisted of 428 patients (247 with transanal endoscopic microsurgery and 181 with transanal minimally invasive surgery). Transanal minimally invasive surgery was associated with shorter operative time and length of stay. Poor quality excision was similar (8% vs 11%; p = 0.233). There were also no differences in peritoneal violation (3% vs 3%; p = 0.965) and postoperative complications (11% vs 9%; p = 0.477). Cumulative 5-year disease-free survival for patients undergoing transanal endoscopic microsurgery was 80% compared with 78% for patients undergoing transanal minimally invasive surgery (log rank p = 0.824). The incidence of local recurrence for patients with malignancy who did not undergo immediate salvage surgery was 7% (8/117) for transanal endoscopic microsurgery and 7% (7/94) for transanal minimally invasive surgery (p = 0.864). LIMITATIONS: All of the procedures were also performed at high-volume referral centers by specialist colorectal surgeons with slightly differing perioperative practices and different time periods. CONCLUSIONS: High-quality local excision for benign and rectal neoplasms can be equally achieved using transanal endoscopic microsurgery or transanal minimally invasive surgery. The choice of operating platform for local excisions of rectal neoplasms should be based on surgeon preference, availability, and cost. See Video Abstract at http://links.lww.com/DCR/A382.


Subject(s)
Anal Canal/surgery , Margins of Excision , Neoplasm, Residual , Rectal Neoplasms , Transanal Endoscopic Microsurgery , Aged , Anal Canal/pathology , Cohort Studies , Disease-Free Survival , Female , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Minimally Invasive Surgical Procedures/adverse effects , Minimally Invasive Surgical Procedures/methods , Minimally Invasive Surgical Procedures/standards , Neoplasm Staging , Neoplasm, Residual/etiology , Neoplasm, Residual/prevention & control , Operative Time , Outcome and Process Assessment, Health Care , Quality Assurance, Health Care , Rectal Neoplasms/epidemiology , Rectal Neoplasms/pathology , Rectal Neoplasms/surgery , Transanal Endoscopic Microsurgery/adverse effects , Transanal Endoscopic Microsurgery/methods , Transanal Endoscopic Microsurgery/standards , United Kingdom/epidemiology
3.
Ann Surg ; 265(6): 1141-1145, 2017 06.
Article in English | MEDLINE | ID: mdl-27257737

ABSTRACT

OBJECTIVE: To determine the nature and frequency of distorted presentation or "spin" (ie, specific reporting strategies which highlight that the experimental treatment is beneficial, despite a statistically nonsignificant difference for the primary outcome, or distract the reader from statistically nonsignificant results) in published reports of randomized controlled trials (RCTs) with statistically nonsignificant results for primary outcomes in surgical journals. BACKGROUND: Multiple reports have suggested that interpretation of RCT results in medical journals can be distorted by authors of published reports. METHODS: Using a defined search strategy, RCTs with clearly nonsignificant results for the primary outcome (P > 0.05) form 10 high-impact factor surgical journals (Annals of Surgery, Journal of Neurology, Neurosurgery and Psychiatry, Journal of Heart and Lung Transplantation, American Journal of Transplantation, British Journal of Surgery, Journal of Bone and Joint Surgery, Journal of the American College of Surgeons, Endoscopy, Archives of Surgery, and Liver transplantation), published between July 2013 to July 2015, were identified. Two reviewers independently appraised each selected article using a validated, standardized data abstraction form. RESULTS: In all, 110 eligible RCTs with nonsignificant primary outcomes were appraised. The title was reported with spin in 8 (7%) articles. Forty-four (40%) included abstracts and 39 (35%) main texts were classified as having spin in at least 1 section. The level of spin was high in 16 (14%) abstract and 19 (19%) main-text "Conclusions" sections. Twenty-five articles (23%) recommended the intervention of interest despite a nonsignificant primary outcome. There was no relationship between trial funding source, use of statistician and article section, and the presence of spin. CONCLUSIONS: In RCTs with statistically nonsignificant primary outcomes published in surgical journals, the reporting and interpretation of findings was frequently inconsistent with the results.


Subject(s)
Data Interpretation, Statistical , General Surgery , Publishing/statistics & numerical data , Randomized Controlled Trials as Topic/statistics & numerical data , Humans , Journal Impact Factor , Periodicals as Topic
4.
Dis Colon Rectum ; 59(4): 340-50, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26953993

ABSTRACT

BACKGROUND: Transanal mesorectal resection has been developed to facilitate minimally invasive proctectomy for rectal cancer. OBJECTIVE: The purpose of this study was to evaluate the evidence regarding technical parameters, oncological outcomes, morbidity, and mortality after transanal mesorectal resection. DATA SOURCES: The Cochrane Library, PubMed, and MEDLINE databases were reviewed. STUDY SELECTION: Systematic review of the literature from January 2005 to September 2015 was used for study selection. INTERVENTION: Intervention included transanal mesorectal resection for rectal cancer. MAIN OUTCOME MEASURES: Technical parameters, histological outcomes, morbidity, and mortality were the outcomes measured. RESULTS: Fifteen predominately retrospective studies involving 449 patients were included (mean age, 64.3 years; 64.1% men). Different platforms were used. The operative mortality rate was 0.4% and the cumulative morbidity rate 35.5%. Circumferential resection margins were clear in 98%, and the resected mesorectum was grade III in 87% of patients. Median follow-up was 14.7 months. There were 4 local recurrences (1.5%) and 12 patients (5.6%) with metastatic disease. No study followed patients long enough to report on 5-year overall and disease-free survival rates. Functional outcome was only reported in 3 studies. LIMITATIONS: A low number of procedures were performed by expert early adopters. There are no comparative or randomized data included in this study and inconsistent reporting of outcome variables. CONCLUSIONS: Transanal mesorectal resection for rectal cancer may enhance negative circumferential margin rates with a reasonable safety profile. Contemporary randomized, controlled studies are required before there can be universal recommendation.


Subject(s)
Rectal Neoplasms/surgery , Rectum/surgery , Transanal Endoscopic Surgery , Disease-Free Survival , Humans , Treatment Outcome
5.
Eur J Gastroenterol Hepatol ; 26(12): 1408-14, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25244412

ABSTRACT

OBJECTIVES: National Institute for Health and Clinical Excellence (NICE) guidelines were introduced in the UK to ensure that patients with high-risk symptoms of colorectal cancer were reviewed promptly. We assessed the proportion of patients referred to our department's nurse-led 2-week wait (2WW) clinic with high-risk symptoms or signs that met these guidelines and the rate of colorectal cancer pickup. PATIENTS AND METHODS: Patients were identified from a prospectively maintained logbook of 2WW referrals over a 1-year period (1 January 2008-31 December 2008). Computerized notes were reviewed to obtain the following information: referral symptoms or signs and the proportion of patients diagnosed with colorectal cancer. RESULTS: A total of 720 patients were seen in the 2WW clinic over this period. Only 356/720 (49.4%) met the referral criteria. The overall pickup rate of colorectal cancer was 52/720 (7.2%) and was not found to be significantly higher in patients meeting guidelines compared with those who did not exhibit these features (7.6 vs. 6.9%; P=0.771). Over the 5-year follow-up period, no patients discharged from the 2WW pathway subsequently re-presented with colorectal cancer. CONCLUSION: Over half of the referrals did not meet the NICE criteria, suggesting that the system is being used as a rapid access route to investigation. Despite this, there is no significant difference in the pickup rate of colorectal cancer in patients with or without high-risk features. Nurse-led 2WW clinics with subsequent investigation appear to be effective in both the identification and exclusion of colorectal cancer.


Subject(s)
Colorectal Neoplasms/diagnosis , Early Detection of Cancer , Tertiary Care Centers , Waiting Lists , Adult , Aged , Aged, 80 and over , Barium Sulfate , Colonoscopy , Colorectal Neoplasms/epidemiology , Contrast Media , Early Detection of Cancer/methods , Early Detection of Cancer/standards , England/epidemiology , Female , Guideline Adherence , Humans , Male , Middle Aged , Practice Guidelines as Topic , Practice Patterns, Physicians' , Predictive Value of Tests , Program Evaluation , Referral and Consultation , Retrospective Studies , Risk Assessment , Risk Factors , Sigmoidoscopy , Tertiary Care Centers/standards , Time Factors , Tomography, X-Ray Computed , Young Adult
6.
Ann Surg ; 259(1): 193-6, 2014 Jan.
Article in English | MEDLINE | ID: mdl-23732270

ABSTRACT

OBJECTIVE: To determine the proportion of registered trials published in the surgical literature, to compare, in registered trials, the primary outcomes registered with those published and to determine whether outcome-reporting bias favored significant primary outcomes. BACKGROUND: Trial protocol registration before patient enrolment for randomized controlled trials (RCTs) is a perquisite for many journals in attempt to decrease publication and selective reporting bias. Analysis of the medical literature demonstrates poor registration rates with discrepancies between reported and registered primary outcomes. This has not been evaluated in contemporary surgical journals. METHODS: RCTs were identified for 2009 and 2010 from 10 high-impact factor surgical journals. One investigator identified all RCTs and extracted primary and secondary outcomes, dates of commencement and completion of study, funding source, and trial registration number. Trial registers were searched using the trial registration number for primary and secondary outcomes, dates of commencement and completion of study, and date of registration. Trial registration rates and registration adequacy were recorded. Register and published primary outcomes were then compared. RESULTS: A total of 246 papers were analyzed, among which 86 (34.9%) were not registered and 52 (21%) were inadequately registered. Of the 108 adequately registered trials, 32 (29%) had a discrepancy between the published primary outcome and that registered in trial register. In the 24 published studies where it was possible to assess, the discrepancy favored a statistically significant primary outcome in 22 (91.7%) whereas in 2 (8.3%) the discrepancy produced a statistically insignificant result. CONCLUSIONS: Less than half of all RCTs published in general surgical journals were adequately registered, and approximately 30% had discrepancies in the registered and published primary outcome with 90% of those assessable favoring a statistically positive result.


Subject(s)
Publishing/standards , Randomized Controlled Trials as Topic/standards , General Surgery , Publication Bias , Registries/standards
7.
J Med Case Rep ; 2: 179, 2008 May 27.
Article in English | MEDLINE | ID: mdl-18505563

ABSTRACT

INTRODUCTION: This report describes a rare complication of colonoscopy and reviews the literature with regard to other rare causes of acute abdominal presentations following colonoscopy. CASE PRESENTATION: After a therapeutic colonoscopy a 60-year-old woman developed an acute abdomen. At laparotomy she was discovered to have small bowel obstruction secondary to incarceration through a congenital band adhesion. CONCLUSION: Although there is no practical way in which such rare complications can be predicted, this case report emphasises the wide array of pathologies that can result in acute abdominal symptoms following colonoscopy.

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