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

Benign Adenomatous Sigmoidal Polyp, Requiring Surgery Clinical Trial

— LATA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01033838
• Other study ID #: S51801-B32220097328
• Status: Recruiting
• Phase: Phase 2
• First received: December 16, 2009
• Last updated: December 16, 2009
• Start date: December 2009

Study information

• Verified date: December 2009
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Albert M Wolthuis, MD
• Phone: +3216344265
• Email: albert.wolthuis[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• rectosigmoid resection

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in analgetic need			No
Secondary	reduction in hospital stay within an ERAS-program			No
Secondary	effect on the inflammatory response			No
Secondary	effect on anal continence			No
Secondary	procedural cost assessment (incorporating operative time)			No
Secondary	overall cost assessment			No