Randomized Trial Comparing Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Transrectal Specimen Retrieval
LATA
Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval
1 other identifier
interventional
1
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 16, 2009
CompletedFirst Posted
Study publicly available on registry
December 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedJuly 1, 2024
June 1, 2024
2 years
December 16, 2009
June 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in analgetic need
Secondary Outcomes (5)
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
Study Arms (2)
laparoscopic-assisted rectosigmoid resection
ACTIVE COMPARATORlaparoscopic rectosigmoid resection and transrectal retrieval
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age 18-90
- Symptomatic recurrent diverticular disease
- Benign adenomatous polyp, requiring surgery
- Early non-transmural sigmoidtumor
- Signed written informed consent, approved by ethical committee
You may not qualify if:
- Patients unsuitable for laparoscopy
- Pregnancy
- ASA \>III
- Coagulation disorders
- Anti-coagulants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leuven
Leuven, 3000, Belgium
Related Publications (1)
Wolthuis AM, Fieuws S, Van Den Bosch A, de Buck van Overstraeten A, D'Hoore A. Randomized clinical trial of laparoscopic colectomy with or without natural-orifice specimen extraction. Br J Surg. 2015 May;102(6):630-7. doi: 10.1002/bjs.9757. Epub 2015 Mar 12.
PMID: 25764376DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 16, 2009
First Posted
December 17, 2009
Study Start
December 1, 2009
Primary Completion
December 1, 2011
Study Completion
June 1, 2025
Last Updated
July 1, 2024
Record last verified: 2024-06