Methodological and ethical quality of randomized controlled clinical trials in gastrointestinal surgery.

BACKGROUND: The randomized controlled trial (RCT) is the gold standard tool used to evaluate therapeutic interventions. Methodological and ethical aspects should be adequately reported to enable readers to make informed and justified judgments regarding the validity of a trial and the treatment effectiveness. OBJECTIVE: The aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in gastrointestinal surgery and to assess the relationship between these two qualities. STUDY DESIGN: All of the articles chosen for review reported on phase III randomized controlled gastrointestinal surgical trials were published in 12 international journals during 2006 and 2007. The eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. The methodological quality was evaluated using the Jadad scale, and the ethical quality was evaluated using the Berdeu score. RESULTS: The mean Jadad score was 9.7 ± 1.78. The methodological quality was insufficient in 64 RCTs (37.4 %; Jadad score <9). The mean Berdeu score was 0.36 ± 0.08. The journal impact factor, number of randomized patients, and number of centers correlated with the outcome of the Jadad score, and the journal impact factor, industry funding, and year in which the trial began correlated with the outcome of the Berdeu score. Informed consent from patients was not obtained in 7 % (n = 12) of the RCTs, and research ethics committee approval was not mentioned in 14.6 % (n = 25) of the RCTs. CONCLUSIONS: The reporting of gastrointestinal surgery RCTs is less than optimal. In our study, the trials of higher methodological quality were more likely to provide information about their ethical aspects. These results suggest the need for more attention to be paid to the conduct of clinical research and the reporting of ethical aspects. The appropriation of the ethical rules by surgeons involved in human clinical trials could improve the methodology and reporting of RCTs in gastrointestinal surgery.

Combined transanal and laparoscopic approach for the treatment of deep endometriosis infiltrating the rectum.

BACKGROUND: Two surgical approaches are employed in the treatment of deep infiltrating endometriosis of the rectum (DIER): colorectal resection and nodule excision. In 2009, we introduced a new technique for transanal full thickness disc excision of endometriotic nodules infiltrating the low and middle rectum, using the Contour® Transtar™ stapler (Ethicon Endo-Surgery inc., Cincinnati, OH, USA). The aim of this retrospective study was to describe the technique and to present data on the feasibility of this technique. METHODS: From April 2009 to October 2010, all patients presenting with DIER and undergoing full thickness excision using the Contour® Transtar™ stapler were enrolled in the study. Pre-, intra- and post-operative data were collected and reported. RESULTS: Six nulliparous women were managed using this technique during the study period. The rectal wall discs removed measured from 40 × 45 to 60 × 50 mm. In two cases, microscopic foci were noted on one of the margins but in four cases the limits were clear. Operating time varied from 180 to 450 min. Four women were completely free of post-operative digestive complaints. CONCLUSIONS: Despite the small numbers in this series, our data suggest that the new technique of transanal rectal disc excision using the contour stapler may be applied in patients with infiltrating endometrial nodules of the rectum up to 10 cm from the anal margin and up to 5 cm in diameter. This new procedure promises to be a useful addition to the surgeon's armamentarium in a multidisciplinary approach to deep pelvic endometriosis.

Ogilvie's syndrome-related right colon perforation after cesarean section: a case series.

The objective of this article is to discuss and report three cases of right colon perforation secondary to postcesarean Ogilvie's syndrome (OS; colonic pseudo-obstruction) requiring right hemicolectomy. We retrospectively reviewed the case notes of three patients who underwent caesarean section and postoperatively developed OS. OS is an uncommon problem in patients undergoing caesarean section. Abdominal X-ray and water-soluble contrast enema are the main diagnostic modalities. Drip-suck therapy along with endoscopic or pharmacological decompression should be performed in early stages. In a significant percentage of patients, diagnosis is delayed resulting in bowel ischemia and perforation requiring surgical resection and adding significant mortality/morbidity. We recommend our obstetric colleagues to involve surgical team in earlier stages to avoid surgery-related mortality and morbidity. We also advocate general surgeons to be aware of OS in patients after caesarean section and recommend a stepwise systematic approach toward the diagnosis and management of OS.