Actively Recruiting

Phase 2
Age: 18Years - 90Years
All Genders
NCT01033838

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

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-01

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Participants Needed

1

Research Sites

808 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 90 years
  • Symptomatic recurrent diverticular disease
  • Benign adenomatous polyp requiring surgery
  • Early non-transmural sigmoid tumor
  • Signed written informed consent approved by ethical committee
Not Eligible

You will not qualify if you...

  • Patients unsuitable for laparoscopy
  • Pregnancy
  • ASA classification greater than III
  • Coagulation disorders
  • Use of anti-coagulants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospitals Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

A

Albert M Wolthuis, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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