DeloRes trial: study protocol for a randomized trial comparing two standardized surgical approaches in rectal prolapse - Delorme’s procedure versus resection rectopexy

Trials

Stefan Post¹  Peter Kienle¹  Christoph M Seiler⁴  Christina Klose³  Petra Schiller³  Meinhard Kieser³  Dieter Bussen²  Andreas Joos²  Alexander Herold²  Florian Herrle¹  Simone Rothenhoefer¹ 

[1] Department of Surgery

[2] , University Medical Centre Mannheim (UMM), University of Heidelberg, Heidelberg, Germany;Institute of Proctology Mannheim (EDZ), Mannheim, Germany;Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany;Study Centre of the German Surgical Society, University of Heidelberg, Heidelberg, Germany

关键词: Recurrence;    Resection rectopexy;    Delorme’s procedure;    Surgery;    Rectal prolapse;   

Others  :  1095358
DOI  :  10.1186/1745-6215-13-155

 received in 2011-12-20, accepted in 2012-08-14,  发布年份 2012

【 摘 要 】

Background

More than 100 surgical approaches to treat rectal prolapse have been described. These can be done through the perineum or transabdominally. Delorme’s procedure is the most frequently used perineal, resection rectopexy the most commonly used abdominal procedure. Recurrences seem more common after perineal compared to abdominal techniques, but the latter may carry a higher risk of peri- and postoperative morbidity and mortality.

Methods/Design

DeloRes is a randomized, controlled, observer-blinded multicenter trial with two parallel groups. Patients with a full-thickness rectal prolapse (third degree prolapse), considered eligible for both operative methods are included. The primary outcome is time to recurrence of full-thickness rectal prolapse during the 24 months following primary surgery. Secondary endpoints are time to and incidence of recurrence of full-thickness rectal prolapse during the 5-year follow-up, duration of surgery, morbidity, hospital stay, quality of life, constipation, and fecal incontinence. A meta-analysis was done on the basis of the available data on recurrence rates from 17 publications comprising 1,140 patients. Based on the results of a meta-analysis it is assumed that the recurrence rate after 2 years is 20% for Delorme’s procedure and 5% for resection rectopexy. Considering a rate of lost to follow-up without recurrence of 30% a total of 130 patients (2 x 65 patients) was calculated as an adequate sample size to assure a power of 80% for the confirmatory analysis.

Discussion

The DeloRes Trial will clarify which procedure results in a smaller recurrence rate but also give information on how morbidity and functional results compare.

Trial registration

German Clinical Trial Number DRKS00000482

【 授权许可】

   
2012 Rothenhoefer et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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