RecruitingPhase 2NCT01033838

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

Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

1 participants

Start Date

Dec 1, 2009

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria5

  • 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 Criteria5

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

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Interventions

PROCEDURErectosigmoid resection

Locations(1)

University Hospitals Leuven

Leuven, Belgium

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NCT01033838