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Clinical Trials/NCT01326052
NCT01326052CompletedPhase 3

Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function

University of Roma La Sapienza2 sites in 1 country150 target enrollmentStarted: January 1, 2004Last updated:
Conditions
Interventions

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

Experimental

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

Active Comparator

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

Sponsor
University of Roma La Sapienza
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Francesco Saverio Mari

Reserch Fellows

University of Roma La Sapienza

Study Sites (2)

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