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

U

Universitaire Ziekenhuizen KU Leuven

Status and phase

Unknown
Phase 2

Conditions

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

Treatments

Procedure: rectosigmoid resection

Study type

Interventional

Funder types

Other

Identifiers

NCT01033838
S51801-B32220097328

Details and patient eligibility

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.

Enrollment

1 estimated patient

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1 participants in 2 patient groups

laparoscopic-assisted rectosigmoid resection
Active Comparator group
Treatment:
Procedure: rectosigmoid resection
laparoscopic rectosigmoid resection and transrectal retrieval
Experimental group
Treatment:
Procedure: rectosigmoid resection

Trial contacts and locations

1

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Central trial contact

Albert M Wolthuis, MD

Data sourced from clinicaltrials.gov

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