Randomized Trial Comparing Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Transrectal Specimen Retrieval

Phase 2

Recruiting

• Conditions: Symptomatic Recurrent Diverticular Disease; Early Non-transmural Sigmoidtumor; Benign Adenomatous Sigmoidal Polyp, Requiring Surgery
• Interventions: Procedure: rectosigmoid resection

• Registration Number: NCT01033838
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Laparoscopic anterior resection is a standardized procedure requiring a small muscle split incision to retrieve the specimen and to fashion the proximal part of the double stapled anastomosis. Most patients can be included within a standardized perioperative care program called Enhanced Recovery After Surgery (ERAS). A new evolution as a primary step towards a complete Natural Orifice Translumenal Endoscopic Surgery (NOTES)-procedure is a hybrid approach (transrectal and laparoscopic). The dissection is performed laparoscopically but the specimen is retrieved within an endobag through the rectum. The anastomosis is created intracorporeally using a triple stapled technique. There are no trials available in the literature concerning these 2 techniques. Therefore this study will be undertaken to establish the role of the 2 surgical procedures and to compare them after short-term follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Primary Completion: 2011-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Age 18-90
• Symptomatic recurrent diverticular disease
• Benign adenomatous polyp, requiring surgery
• Early non-transmural sigmoidtumor
• Signed written informed consent, approved by ethical committee

Exclusion Criteria

• Patients unsuitable for laparoscopy
• Pregnancy
• ASA >III
• Coagulation disorders
• Anti-coagulants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic-assisted rectosigmoid resection	rectosigmoid resection	-
laparoscopic rectosigmoid resection and transrectal retrieval	rectosigmoid resection	-

Primary Outcome Measures

Name	Time	Method
Reduction in analgetic need

Secondary Outcome Measures

Name	Time	Method
reduction in hospital stay within an ERAS-program
effect on the inflammatory response
effect on anal continence
procedural cost assessment (incorporating operative time)
overall cost assessment

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium