Sexual Function DisturbancesIMAPSEXNCT04752241
Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease
A study testing Inferior Mesenteric Artery Preservation and Inferior Mesenteric Artery Ligation in people with Sexual Function Disturbances, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sexual Function Disturbances
- What is being tested?
- Inferior Mesenteric Artery Preservation and Inferior Mesenteric Artery Ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2012to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diverticular disease
- Diverticulitis
- BMI under 35 Kg/mq
- ASA score from I to III
- Standardized sigmoid, left colon or rectal resection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Sexual Function Disturbances
- Being tested
- Inferior Mesenteric Artery Preservation, Inferior Mesenteric Artery Ligation
- Keywords
- Sexual function, Colonic diverticular disease, Inferior mesenteric artery-preserving, Neosigmoid Denervation, Postoperative sexual dysfunction
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior Mesenteric Artery PreservationProcedure or surgery
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Inferior Mesenteric Artery LigationProcedure or surgery
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
| Study group | Role | What they receive |
|---|---|---|
| IMAP | Experimental | Inferior Mesenteric Artery Preservation Performing left hemicolectomy and anterior rectal resection the IMA was preserved ligating close to the colonic wall the sigmoids arteries. Receives: Procedure: Inferior Mesenteric Artery Preservation |
| IMAS | Active comparator | Inferior Mesenteric Artery Ligation Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery Receives: Procedure: Inferior Mesenteric Artery Ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 6 years after surgery
Secondary outcomes (8)
Sexual Function Male 1
assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test
Measured: 12 month after surgery
Sexual Function Male 2
assess the patients' sexual disorders with International Index of Erectile Function (IIEF) 15-items test
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 )
Measured: 6 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start1 Jan 2012
- Primary completion1 Jan 2018
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Function DisturbancesStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Saverio Mari, MD, PhD, FACS, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752241
- Sponsor's protocol ID
- DS-041
- Acronym
- IMAPSEX
- Status last verified
- Jul 2024
- First submitted
- 8 Feb 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease
- ClinicalTrials.gov ID
- NCT04752241
- Acronym / sponsor ID
- IMAPSEX / DS-041
- Conditions
- Sexual Function Disturbances
- Keywords
- Sexual function, Colonic diverticular disease, Inferior mesenteric artery-preserving, Neosigmoid Denervation, Postoperative sexual dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMAP | Experimental | Procedure: Inferior Mesenteric Artery PreservationInferior Mesenteric Artery Preservation Performing left hemicolectomy and anterior rectal resection the IMA was preserved ligating close to the colonic wall the sigmoids arteries. |
| IMAS | Active comparator | Procedure: Inferior Mesenteric Artery LigationInferior Mesenteric Artery Ligation Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diverticular disease
- Diverticulitis
- BMI under 35 Kg/mq
- ASA score from I to III
- Standardized sigmoid, left colon or rectal resection
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inferior Mesenteric Artery PreservationPerforming left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries. | Procedure or surgery | IMAP |
| Inferior Mesenteric Artery LigationPerforming left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery | Procedure or surgery | IMAS |
Primary outcome
Sexual disfunction 1
Time frame: 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
Time frame: 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)
8 secondary outcomes
Sexual Function Male 1
Time frame: 12 month after surgery
Sexual Function Male 2
Time frame: 6 years after surgery
Sexual Function Female 1
Time frame: 12 months after surgery
Sexual Function Female 2
Time frame: 6 years after surgery
Quality of Life 1
Time frame: 12 months after surgery
Quality of Life 2
Time frame: 6 years after surgery
Quality of life SF-36 1
Time frame: 12 months after surgery
Quality of life SF-36 2
Time frame: 6 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Sexual Function Disturbances
Active, not recruiting
Sexual Health and Rehabilitation Online (SHAREonline)
Cancer Survivorship, Sexual Function Disturbances
Active, not recruiting
PRP Injections for Genitourinary Syndrome of Menopause
PRP, Sexual Function Disturbances
Active, not recruiting
Sexual Counseling's Impact on Hip Replacement Patients' Sexual Function and Quality of Life: a PLISSIT Model Study
Hip Arthropathy, Sexual Function Disturbances
Recruiting
TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer
Prostate Cancer, Adverse Effects Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inferior Mesenteric Artery Preservation and Inferior Mesenteric Artery Ligation in people with Sexual Function Disturbances, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual disfunction 1 (time frame: 12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.