Back to resultsImprovement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis (IPIMAL)
Primary Purpose
Defecatory Disorders After Left Colonic or Rectal Resection
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Inferior Mesenteric Artery Preservation
Inferior Mesenteric Artery Ligation
Sponsored by
About this trial
This is an interventional treatment trial for Defecatory Disorders After Left Colonic or Rectal Resection
Eligibility Criteria
Inclusion Criteria:
- Age from 18 to 80 years
- BMI<35
- Presence of symptomatic diverticular disease
- ASA I-III
Exclusion Criteria:
- age > 80 years
- BMI>35
- ASA IV
- Hinchey III-IV
- Past performed procedure that could be modify the nervous pattern (i.e. colorectal surgery, left nephrectomy, hysteroannessectomy)
Sites / Locations
- Azienda Ospedaliera Sant'Andrea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Inferior Mesenteric Artery Preservation
Inferior Mesenteric Artery Ligation
Arm Description
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Outcomes
Primary Outcome Measures
Change from preoperative time in anorectal function
We evaluate the presence of modification in anorectal function respect to the preoperative time. This is assessed with specific questionnnaires and anorectal manometry
Secondary Outcome Measures
Constipation
We evaluate with a questionnaire (Constipation scoring system) the presence of postoperative constipation
Incontinence
We evaluate with a questionnaire (Continence scale), anorectal manometry and eventually with endoanal ultrasonography the precence of incontinence
Quality of life
We evaluate with SF-36 questionnaire the postoperative quality of life
Postoperative complication
We evaluate the presence of postoperative complication such as anastomotic leakage, anastomotic stricture, pneumonia etc.
Full Information
NCT ID
NCT01326052
First Posted
March 25, 2011
Last Updated
June 12, 2012
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01326052
Brief Title
Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis
Acronym
IPIMAL
Official Title
Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that IMA preservation could improve patient's quality of life reducing incontinence and/or constipation rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Defecatory Disorders After Left Colonic or Rectal Resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inferior Mesenteric Artery Preservation
Arm Type
Experimental
Arm Description
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Arm Title
Inferior Mesenteric Artery Ligation
Arm Type
Active Comparator
Arm Description
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Intervention Type
Procedure
Intervention Name(s)
Inferior Mesenteric Artery Preservation
Other Intervention Name(s)
IMA-P
Intervention Description
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Intervention Type
Procedure
Intervention Name(s)
Inferior Mesenteric Artery Ligation
Other Intervention Name(s)
IMA-L
Intervention Description
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Primary Outcome Measure Information:
Title
Change from preoperative time in anorectal function
Description
We evaluate the presence of modification in anorectal function respect to the preoperative time. This is assessed with specific questionnnaires and anorectal manometry
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
Constipation
Description
We evaluate with a questionnaire (Constipation scoring system) the presence of postoperative constipation
Time Frame
6 and 12 months
Title
Incontinence
Description
We evaluate with a questionnaire (Continence scale), anorectal manometry and eventually with endoanal ultrasonography the precence of incontinence
Time Frame
6 and 12 months
Title
Quality of life
Description
We evaluate with SF-36 questionnaire the postoperative quality of life
Time Frame
6 and 12 months
Title
Postoperative complication
Description
We evaluate the presence of postoperative complication such as anastomotic leakage, anastomotic stricture, pneumonia etc.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age from 18 to 80 years
BMI<35
Presence of symptomatic diverticular disease
ASA I-III
Exclusion Criteria:
age > 80 years
BMI>35
ASA IV
Hinchey III-IV
Past performed procedure that could be modify the nervous pattern (i.e. colorectal surgery, left nephrectomy, hysteroannessectomy)
Facility Information:
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Rome
ZIP/Postal Code
00188
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis
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