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

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).

Study Overview

• Status: Completed
• Conditions: Sexual Function Disturbances
• Intervention / Treatment: Procedure: Inferior Mesenteric Artery Preservation; Procedure: Inferior Mesenteric Artery Ligation

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00188
    • Azienda Ospedaliera Sant'Andrea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Inferior Mesenteric Artery Preservation; Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Active Comparator: IMAS; Inferior Mesenteric Artery Ligation Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery	Procedure: Inferior Mesenteric Artery Ligation; Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual disfunction 1	Presence of sexual disfunction ( defined through the evaluation of sexual desire ,arousal, lubrication , orgasmic function, overall satisfaction, pain, intercourse satisfaction , erectile function)	12 months after surgery
Sexual disfunction 2	Presence of sexual disfunction ( defined through the evaluation of sexual desire ,arousal, lubrication , orgasmic function, overall satisfaction, pain, intercourse satisfaction , erectile function)	6 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Function Male 1	assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test	12 month after surgery
Sexual Function Male 2	assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test	6 years after surgery
Sexual Function Female 1	assess the patients' sexual disorders withFemale Sexual Function Index (FSFI) a 19-item test (score below 26.55 indicates the presence of sexual dysfunctions)	12 months after surgery
Sexual Function Female 2	assess the patient's sexual disorders with Female Sexual Function Index (FSFI) 19-item test (score below 26.55 indicates the presence of sexual dysfunctions)	6 years after surgery
Quality of Life 1	The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30 ( European organisation for research and treatment of cancer- quality of life questionnaire)	12 months after surgery
Quality of Life 2	The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30( European organisation for research and treatment of cancer- quality of life questionnaire)	6 years after surgery
Quality of life SF-36 1	The impact of sexual disorders in QoL was evaluated using SF-36 score (Short Form Health Survey 36)	12 months after surgery
Quality of life SF-36 2	The impact of sexual disorders in QoL was evaluated using SF- 36 score ( Short Form Health Survey 36 )	6 years after surgery

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Sexual function; Colonic diverticular disease; Inferior mesenteric artery-preserving; Neosigmoid Denervation; Postoperative sexual dysfunction
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulum; Diverticular Diseases
• Other Study ID Numbers: DS-041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No