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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sexual Function Disturbances

Intervention / Treatment
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* Procedure: Inferior Mesenteric Artery Preservation
* Procedure: Inferior Mesenteric Artery Ligation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMAP<br>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<br>* Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.<br>|
| Active Comparator: IMAS<br>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<br>* Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Function Male 1 | assess the patients' sexual disorders with International Index of Erectile Function (IIEF) | 12 month after surgery | 
| Sexual Function Male 2 | assess the patients' sexual disorders with International Index of Erectile Function (IIEF) | 5 years after surgery | 
| Sexual Function Male 3 | assess the patients' sexual disorders with International Index of Erectile Function (IIEF) | 8 years after surgery | 
| Sexual Function Female 1 | assess the patients' sexual disorders withFemale Sexual Function Index (FSFI) | 12 months after surgery | 
| Sexual Function Female 2 | assess the patients' sexual disorders withFemale Sexual Function Index (FSFI) | 5 years after surgery | 
| Sexual Function Female 3 | assess the patients' sexual disorders withFemale Sexual Function Index (FSFI) | 8 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life 1 | The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30 | 12 months after surgery | 
| Quality of Life 2 | The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30 | 5 years after surgery | 
| Quality of Life 3 | The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30 | 8 years after surgery | 
| Quality of Life 4 | The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29 | 12 months after surgery | 
| Quality of Life 5 | The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29 | 5 years after surgery | 
| Quality of Life 6 | The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29 | 8 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual function, Colonic diverticular disease, Inferior mesenteric artery-preserving, Neosigmoid Denervation, Postoperative sexual dysfunction