Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis (IPIMAL)
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ClinicalTrials.gov Identifier: NCT01326052 |
Recruitment Status
:
Completed
First Posted
: March 30, 2011
Last Update Posted
: June 13, 2012
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Condition or disease | Intervention/treatment | Phase |
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Defecatory Disorders After Left Colonic or Rectal Resection | Procedure: Inferior Mesenteric Artery Preservation Procedure: Inferior Mesenteric Artery Ligation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function |
Study Start Date : | January 2004 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Inferior Mesenteric Artery Preservation
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
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Procedure: Inferior Mesenteric Artery Preservation
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Other Name: IMA-P
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Active Comparator: Inferior Mesenteric Artery Ligation
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
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Procedure: Inferior Mesenteric Artery Ligation
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Other Name: IMA-L
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- 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
- Constipation [ Time Frame: 6 and 12 months ]We evaluate with a questionnaire (Constipation scoring system) the presence of postoperative constipation
- Incontinence [ Time Frame: 6 and 12 months ]We evaluate with a questionnaire (Continence scale), anorectal manometry and eventually with endoanal ultrasonography the precence of incontinence
- Quality of life [ Time Frame: 6 and 12 months ]We evaluate with SF-36 questionnaire the postoperative quality of life
- Postoperative complication [ Time Frame: 1 month ]We evaluate the presence of postoperative complication such as anastomotic leakage, anastomotic stricture, pneumonia etc.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326052
Italy | |
Azienda Ospedaliera Sant'Andrea | |
Rome, Italy, 00188 |
Responsible Party: | Francesco Saverio Mari, Reserch Fellows, University of Roma La Sapienza |
ClinicalTrials.gov Identifier: | NCT01326052 History of Changes |
Other Study ID Numbers: |
DS-004 |
First Posted: | March 30, 2011 Key Record Dates |
Last Update Posted: | June 13, 2012 |
Last Verified: | June 2012 |
Additional relevant MeSH terms:
Diverticulum Pathological Conditions, Anatomical |