Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease

NCT ID: NCT04752241

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2024-01-01

Brief Summary

This study aims to evaluate whether IMA sparing may represent an advantage in terms of reduced incidence and severity of sexual dysfunctions after colorectal resections for diverticular disease (DD).

Detailed Description

Enrolled patients were randomly divided into 2 treatment groups. In the first group (IMAP) the IMA was preserved sectioning the sigmoid arteries near colonic wall while, in the second group (IMAS) the IMA was sectioned immediately below the origin of the left colic artery. Incidence and severity of sexual dysfunction and QoL were assessed by four validated questionnaire administered 6,12 months and 5 and 8 years after surgery.

Conditions

Sexual Function Disturbances

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IMAP

Inferior Mesenteric Artery Preservation Performing left hemicolectomy and anterior rectal resection the IMA was preserved ligating close to the colonic wall the sigmoids arteries.

Group Type: EXPERIMENTAL

Inferior Mesenteric Artery Preservation

Intervention Type: PROCEDURE

Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.

IMAS

Inferior Mesenteric Artery Ligation Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery

Group Type: ACTIVE_COMPARATOR

Inferior Mesenteric Artery Ligation

Intervention Type: PROCEDURE

Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery

Interventions

Inferior Mesenteric Artery Preservation

Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.

Intervention Type: PROCEDURE

Inferior Mesenteric Artery Ligation

Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• diverticular disease
• Diverticulitis
• BMI under 35 Kg/mq
• ASA score from I to III
• Standardized sigmoid, left colon or rectal resection

Exclusion Criteria

• complicated diverticulitis (Hinchey III-IV)
• previous abdominal surgery or prostatic and/or gynecological resections
• adverse local condition or the need of multiorgan resection or stoma creation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Francesco Saverio Mari, MD, PhD, FACS

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliera Sant'Andrea

Rome, , Italy

Countries

Italy

Other Identifiers

DS-041

Identifier Type: -

Identifier Source: org_study_id