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

Not Applicable

Completed

• Conditions: Sexual Function Disturbances

• Registration Number: NCT04752241
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2018-01-01
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-12
• Study Completion: 2024-01-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-21
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life SF-36 1	12 months after surgery	The impact of sexual disorders in QoL was evaluated using SF-36 score (Short Form Health Survey 36)
Sexual Function Male 1	12 month after surgery	assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test
Sexual Function Female 1	12 months after surgery	assess the patients' sexual disorders withFemale Sexual Function Index (FSFI) a 19-item test (score below 26.55 indicates the presence of sexual dysfunctions)
Quality of Life 1	12 months after surgery	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)
Quality of Life 2	6 years after surgery	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)
Quality of life SF-36 2	6 years after surgery	The impact of sexual disorders in QoL was evaluated using SF- 36 score ( Short Form Health Survey 36 )
Sexual Function Male 2	6 years after surgery	assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test
Sexual Function Female 2	6 years after surgery	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)

Trial Locations

Locations (1)

Azienda Ospedaliera Sant'Andrea; 🇮🇹 Rome, Italy