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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2025-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Symptomatic Recurrent Diverticular Disease Benign Adenomatous Sigmoidal Polyp, Requiring Surgery Early Non-transmural Sigmoidtumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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laparoscopic-assisted rectosigmoid resection

Group Type ACTIVE_COMPARATOR

rectosigmoid resection

Intervention Type PROCEDURE

laparoscopic rectosigmoid resection and transrectal retrieval

Group Type EXPERIMENTAL

rectosigmoid resection

Intervention Type PROCEDURE

Interventions

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rectosigmoid resection

Intervention Type PROCEDURE

Eligibility Criteria

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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