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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01033838
First Posted: December 17, 2009
Last Update Posted: December 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universitaire Ziekenhuizen Leuven
  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 (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033838


Contacts
Contact: Albert M Wolthuis, MD +3216344265 albert.wolthuis@uzleuven.be

Locations
Belgium
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. A. D'Hoore, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01033838     History of Changes
Other Study ID Numbers: S51801-B32220097328
First Submitted: December 16, 2009
First Posted: December 17, 2009
Last Update Posted: December 17, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Diverticulum
Pathological Conditions, Anatomical