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

Universitaire Ziekenhuizen KU Leuven

Status and phase: Enrolling; 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

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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