Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Change from preoperative time in anorectal function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age from 18 to 80 years
- •Presence of symptomatic diverticular disease
- •ASA I-III
Exclusion Criteria
- •age > 80 years
- •Hinchey III-IV
- •Past performed procedure that could be modify the nervous pattern (i.e. colorectal surgery, left nephrectomy, hysteroannessectomy)
Arms & Interventions
Inferior Mesenteric Artery Preservation
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Intervention: Inferior Mesenteric Artery Preservation (Procedure)
Inferior Mesenteric Artery Ligation
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Intervention: Inferior Mesenteric Artery Ligation (Procedure)
Outcomes
Primary Outcomes
Change from preoperative time in anorectal function
Time Frame: 6 and 12 months
We evaluate the presence of modification in anorectal function respect to the preoperative time. This is assessed with specific questionnnaires and anorectal manometry
Secondary Outcomes
- Constipation(6 and 12 months)
- Quality of life(6 and 12 months)
- Incontinence(6 and 12 months)
- Postoperative complication(1 month)
Investigators
Francesco Saverio Mari
Reserch Fellows
University of Roma La Sapienza