- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04752241
Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease (IMAPSEX)
February 8, 2021 updated by: Francesco Saverio Mari, MD, PhD, FACS, University of Roma La Sapienza
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rome, Italy, 00188
- Azienda Ospedaliera Sant'Andrea
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
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.
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Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
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Active Comparator: IMAS
Inferior Mesenteric Artery Ligation Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
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Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Function Male 1
Time Frame: 12 month after surgery
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assess the patients' sexual disorders with International Index of Erectile Function (IIEF)
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12 month after surgery
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Sexual Function Male 2
Time Frame: 5 years after surgery
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assess the patients' sexual disorders with International Index of Erectile Function (IIEF)
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5 years after surgery
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Sexual Function Male 3
Time Frame: 8 years after surgery
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assess the patients' sexual disorders with International Index of Erectile Function (IIEF)
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8 years after surgery
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Sexual Function Female 1
Time Frame: 12 months after surgery
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assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)
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12 months after surgery
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Sexual Function Female 2
Time Frame: 5 years after surgery
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assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)
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5 years after surgery
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Sexual Function Female 3
Time Frame: 8 years after surgery
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assess the patients' sexual disorders withFemale Sexual Function Index (FSFI)
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8 years after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life 1
Time Frame: 12 months after surgery
|
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30
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12 months after surgery
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Quality of Life 2
Time Frame: 5 years after surgery
|
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30
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5 years after surgery
|
Quality of Life 3
Time Frame: 8 years after surgery
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The impact of sexual disorders in QoL was evaluated using EORTC QLQ-30
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8 years after surgery
|
Quality of Life 4
Time Frame: 12 months after surgery
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The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29
|
12 months after surgery
|
Quality of Life 5
Time Frame: 5 years after surgery
|
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29
|
5 years after surgery
|
Quality of Life 6
Time Frame: 8 years after surgery
|
The impact of sexual disorders in QoL was evaluated using EORTC QLQ-CR29
|
8 years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2004
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2020
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)
February 12, 2021
Last Update Submitted That Met QC Criteria
February 8, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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