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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2009 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
Information provided by:
Universitaire Ziekenhuizen Leuven Identifier:
First received: December 16, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
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 (Participant)
Primary Purpose: Treatment
Official Title: Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Reduction in analgetic need

Secondary Outcome Measures:
  • reduction in hospital stay within an ERAS-program
  • effect on the inflammatory response
  • effect on anal continence
  • procedural cost assessment (incorporating operative time)
  • overall cost assessment

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


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT01033838

Contact: Albert M Wolthuis, MD +3216344265

University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Sub-Investigator: Albert M Wolthuis, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof. Dr. A. D'Hoore, Universitaire Ziekenhuizen Leuven Identifier: NCT01033838     History of Changes
Other Study ID Numbers: S51801-B32220097328
Study First Received: December 16, 2009
Last Updated: December 16, 2009

Additional relevant MeSH terms:
Pathological Conditions, Anatomical processed this record on July 25, 2017