Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease (IMAPSEX)
Primary Purpose
Sexual Function Disturbances
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Inferior Mesenteric Artery Preservation
Inferior Mesenteric Artery Ligation
Sponsored by
About this trial
This is an interventional treatment trial for Sexual Function Disturbances focused on measuring Sexual function, Colonic diverticular disease, Inferior mesenteric artery-preserving, Neosigmoid Denervation, Postoperative sexual dysfunction
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
Sites / Locations
- Azienda Ospedaliera Sant'Andrea
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IMAP
IMAS
Arm Description
Inferior Mesenteric Artery Preservation Performing left hemicolectomy and anterior rectal resection 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
Outcomes
Primary Outcome Measures
Sexual Function Male 1
assess the patients' sexual disorders with International Index of Erectile Function (IIEF)
Sexual Function Male 2
assess the patients' sexual disorders with International Index of Erectile Function (IIEF)
Sexual Function Male 3
assess the patients' sexual disorders with International Index of Erectile Function (IIEF)
Sexual Function Female 1
assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)
Sexual Function Female 2
assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)
Sexual Function Female 3
assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)
Secondary Outcome Measures
Quality of Life 1
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30
Quality of Life 2
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30
Quality of Life 3
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30
Quality of Life 4
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29
Quality of Life 5
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29
Quality of Life 6
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29
Full Information
NCT ID
NCT04752241
First Posted
February 8, 2021
Last Updated
February 8, 2021
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT04752241
Brief Title
Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease
Acronym
IMAPSEX
Official Title
Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2004 (Actual)
Primary Completion Date
January 1, 2012 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Function Disturbances
Keywords
Sexual function, Colonic diverticular disease, Inferior mesenteric artery-preserving, Neosigmoid Denervation, Postoperative sexual dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMAP
Arm Type
Experimental
Arm Description
Inferior Mesenteric Artery Preservation Performing left hemicolectomy and anterior rectal resection the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Arm Title
IMAS
Arm Type
Active Comparator
Arm Description
Inferior Mesenteric Artery Ligation Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Intervention Type
Procedure
Intervention Name(s)
Inferior Mesenteric Artery Preservation
Intervention Description
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Intervention Type
Procedure
Intervention Name(s)
Inferior Mesenteric Artery Ligation
Intervention Description
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
Primary Outcome Measure Information:
Title
Sexual Function Male 1
Description
assess the patients' sexual disorders with International Index of Erectile Function (IIEF)
Time Frame
12 month after surgery
Title
Sexual Function Male 2
Description
assess the patients' sexual disorders with International Index of Erectile Function (IIEF)
Time Frame
5 years after surgery
Title
Sexual Function Male 3
Description
assess the patients' sexual disorders with International Index of Erectile Function (IIEF)
Time Frame
8 years after surgery
Title
Sexual Function Female 1
Description
assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)
Time Frame
12 months after surgery
Title
Sexual Function Female 2
Description
assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)
Time Frame
5 years after surgery
Title
Sexual Function Female 3
Description
assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)
Time Frame
8 years after surgery
Secondary Outcome Measure Information:
Title
Quality of Life 1
Description
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30
Time Frame
12 months after surgery
Title
Quality of Life 2
Description
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30
Time Frame
5 years after surgery
Title
Quality of Life 3
Description
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30
Time Frame
8 years after surgery
Title
Quality of Life 4
Description
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29
Time Frame
12 months after surgery
Title
Quality of Life 5
Description
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29
Time Frame
5 years after surgery
Title
Quality of Life 6
Description
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29
Time Frame
8 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Rome
ZIP/Postal Code
00188
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease
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