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

Sexual Function Disturbances Clinical Trial

— IMAPSEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752241
• Other study ID #: DS-041
• Status: Completed
• Phase: N/A
• Start date: January 1, 2004
• Est. completion date: January 1, 2020

Study information

• Verified date: February 2021
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diverticulum
• Sexual Function Disturbances

Intervention

Procedure:
• Inferior Mesenteric Artery Preservation
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
• Inferior Mesenteric Artery Ligation
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Sant'Andrea	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Function Male 1	assess the patients' sexual disorders with International Index of Erectile Function (IIEF)	12 month after surgery
Primary	Sexual Function Male 2	assess the patients' sexual disorders with International Index of Erectile Function (IIEF)	5 years after surgery
Primary	Sexual Function Male 3	assess the patients' sexual disorders with International Index of Erectile Function (IIEF)	8 years after surgery
Primary	Sexual Function Female 1	assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)	12 months after surgery
Primary	Sexual Function Female 2	assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)	5 years after surgery
Primary	Sexual Function Female 3	assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)	8 years after surgery
Secondary	Quality of Life 1	The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30	12 months after surgery
Secondary	Quality of Life 2	The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30	5 years after surgery
Secondary	Quality of Life 3	The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30	8 years after surgery
Secondary	Quality of Life 4	The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29	12 months after surgery
Secondary	Quality of Life 5	The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29	5 years after surgery
Secondary	Quality of Life 6	The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29	8 years after surgery