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Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01326052
Acronym
IPIMAL
Enrollment
150
Registered
2011-03-30
Start date
2004-01-31
Completion date
2011-12-31
Last updated
2012-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Defecatory Disorders After Left Colonic or Rectal Resection

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.

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

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change from preoperative time in anorectal function6 and 12 monthsWe evaluate the presence of modification in anorectal function respect to the preoperative time. This is assessed with specific questionnnaires and anorectal manometry

Secondary

MeasureTime frameDescription
Constipation6 and 12 monthsWe evaluate with a questionnaire (Constipation scoring system) the presence of postoperative constipation
Incontinence6 and 12 monthsWe evaluate with a questionnaire (Continence scale), anorectal manometry and eventually with endoanal ultrasonography the precence of incontinence
Quality of life6 and 12 monthsWe evaluate with SF-36 questionnaire the postoperative quality of life
Postoperative complication1 monthWe evaluate the presence of postoperative complication such as anastomotic leakage, anastomotic stricture, pneumonia etc.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026