Randomized Trial Comparing Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Transrectal Specimen Retrieval (LATA)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Symptomatic Recurrent Diverticular Disease Benign Adenomatous Sigmoidal Polyp, Requiring Surgery Early Non-transmural Sigmoidtumor |
Procedure: rectosigmoid resection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval |
- Reduction in analgetic need [ Designated as safety issue: No ]
- reduction in hospital stay within an ERAS-program [ Designated as safety issue: No ]
- effect on the inflammatory response [ Designated as safety issue: No ]
- effect on anal continence [ Designated as safety issue: No ]
- procedural cost assessment (incorporating operative time) [ Designated as safety issue: No ]
- overall cost assessment [ Designated as safety issue: No ]
| Estimated Enrollment: | 1 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: laparoscopic-assisted rectosigmoid resection | Procedure: rectosigmoid resection |
| Experimental: laparoscopic rectosigmoid resection and transrectal retrieval | Procedure: rectosigmoid resection |
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Albert M Wolthuis, MD | +3216344265 | albert.wolthuis@uzleuven.be |
| Belgium | |
| University Hospitals Leuven | Recruiting |
| Leuven, Belgium, 3000 | |
| Sub-Investigator: Albert M Wolthuis, MD | |
More Information
No publications provided
| Responsible Party: | Prof. Dr. A. D'Hoore, Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01033838 History of Changes |
| Other Study ID Numbers: | S51801-B32220097328 |
| Study First Received: | December 16, 2009 |
| Last Updated: | December 16, 2009 |
| Health Authority: | Belgium: Institutional Review Board |
Additional relevant MeSH terms:
|
Diverticulum Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013