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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01033838
First received: December 16, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  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

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Reduction in analgetic need [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 October 23, 2014