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

Primary Purpose

Symptomatic Recurrent Diverticular Disease, Benign Adenomatous Sigmoidal Polyp, Requiring Surgery, Early Non-transmural Sigmoidtumor

Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
rectosigmoid resection
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Recurrent Diverticular Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

laparoscopic-assisted rectosigmoid resection

laparoscopic rectosigmoid resection and transrectal retrieval

Arm Description

Outcomes

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

Full Information

First Posted
December 16, 2009
Last Updated
December 16, 2009
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01033838
Brief Title
Randomized Trial Comparing Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Transrectal Specimen Retrieval
Acronym
LATA
Official Title
Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Recurrent Diverticular Disease, Benign Adenomatous Sigmoidal Polyp, Requiring Surgery, Early Non-transmural Sigmoidtumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic-assisted rectosigmoid resection
Arm Type
Active Comparator
Arm Title
laparoscopic rectosigmoid resection and transrectal retrieval
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
rectosigmoid resection
Primary Outcome Measure Information:
Title
Reduction in analgetic need
Secondary Outcome Measure Information:
Title
reduction in hospital stay within an ERAS-program
Title
effect on the inflammatory response
Title
effect on anal continence
Title
procedural cost assessment (incorporating operative time)
Title
overall cost assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albert M Wolthuis, MD
Phone
+3216344265
Email
albert.wolthuis@uzleuven.be
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert M Wolthuis, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25764376
Citation
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.
Results Reference
derived

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

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