Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis
IPIMAL
Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2004
Longer than P75 for phase_3
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
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 25, 2011
CompletedFirst Posted
Study publicly available on registry
March 30, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 13, 2012
June 1, 2012
6 years
March 25, 2011
June 12, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
6 and 12 months
Secondary Outcomes (4)
Constipation
6 and 12 months
Incontinence
6 and 12 months
Quality of life
6 and 12 months
Postoperative complication
1 month
Study Arms (2)
Inferior Mesenteric Artery Preservation
EXPERIMENTALPerforming left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Inferior Mesenteric Artery Ligation
ACTIVE COMPARATORPerforming left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Interventions
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
Eligibility Criteria
You may qualify if:
- Age from 18 to 80 years
- BMI\<35
- Presence of symptomatic diverticular disease
- ASA I-III
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliera Sant'Andrea
Rome, Italy, 00188, Italy
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Reserch Fellows
Study Record Dates
First Submitted
March 25, 2011
First Posted
March 30, 2011
Study Start
January 1, 2004
Primary Completion
January 1, 2010
Study Completion
December 1, 2011
Last Updated
June 13, 2012
Record last verified: 2012-06