Defecatory Disorders After Left Colonic or Rectal ResectionPhase 3IPIMALNCT01326052
Improvement of Anorectal Function While Preserving of Inferior Mesenteric Artery Performing Left Hemicolectomy for Diverticulosis
A Phase 3 study testing Inferior Mesenteric Artery Preservation and Inferior Mesenteric Artery Ligation in people with Defecatory Disorders After Left Colonic or Rectal Resection, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that IMA preservation could improve patient's quality of life reducing incontinence and/or constipation rate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Defecatory Disorders After Left Colonic or Rectal Resection
- 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
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2004to Dec 2011
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 80 years
- BMI<35
- Presence of symptomatic diverticular disease
- ASA I-III
Who cannot join
- age > 80 years
- BMI>35
- ASA IV
- Hinchey III-IV
- Past performed procedure that could be modify the nervous pattern (i.e. colorectal surgery, left nephrectomy, hysteroannessectomy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function
The aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that IMA preservation could improve patient's quality of life reducing incontinence and/or constipation rate.
- Being tested
- Inferior Mesenteric Artery Preservation, Inferior Mesenteric Artery Ligation
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
Also called IMA-P
Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
Inferior Mesenteric Artery LigationProcedure or surgery
Also called IMA-L
Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
| Study group | Role | What they receive |
|---|---|---|
| Inferior Mesenteric Artery Preservation | Experimental | Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries. Receives: Procedure: Inferior Mesenteric Artery Preservation |
| Inferior Mesenteric Artery Ligation | Active comparator | 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.
Change from preoperative time in anorectal function
We evaluate the presence of modification in anorectal function respect to the preoperative time. This is assessed with specific questionnnaires and anorectal manometry
Measured: 6 and 12 months
Secondary outcomes (4)
Constipation
We evaluate with a questionnaire (Constipation scoring system) the presence of postoperative constipation
Measured: 6 and 12 months
Incontinence
We evaluate with a questionnaire (Continence scale), anorectal manometry and eventually with endoanal ultrasonography the precence of incontinence
Measured: 6 and 12 months
Quality of life
We evaluate with SF-36 questionnaire the postoperative quality of life
Measured: 6 and 12 months
Postoperative complication
We evaluate the presence of postoperative complication such as anastomotic leakage, anastomotic stricture, pneumonia etc.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startJan 2004
- Primary completionJan 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defecatory Disorders After Left Colonic or Rectal ResectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 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, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326052
- Sponsor's protocol ID
- DS-004
- Acronym
- IPIMAL
- Status last verified
- Jun 2012
- First submitted
- 25 Mar 2011
- Last updated
- 13 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inferior Mesenteric Artery Preservation Performing Left Hemicolectomy for Diverticulosis in the Anorectal Function
- ClinicalTrials.gov ID
- NCT01326052
- Acronym / sponsor ID
- IPIMAL / DS-004
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Jan 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Mar 2011 (estimated)
- 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.
The aim of the study is to evaluate the anorectal function after hemicolectomy if we preserve or not the Inferior Mesenteric Artery (IMA). This study wants to demonstrate that IMA preservation could improve patient's quality of life reducing incontinence and/or constipation rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inferior Mesenteric Artery Preservation | Experimental | Procedure: Inferior Mesenteric Artery PreservationPerforming left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries. |
| Inferior Mesenteric Artery Ligation | Active comparator | Procedure: Inferior Mesenteric Artery LigationPerforming left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 80 years
- BMI<35
- Presence of symptomatic diverticular disease
- ASA I-III
Key exclusion criteria (5 listed)
- age > 80 years
- BMI>35
- ASA IV
- Hinchey III-IV
- Past performed procedure that could be modify the nervous pattern (i.e. colorectal surgery, left nephrectomy, hysteroannessectomy)
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 PreservationAlso: IMA-PPerforming left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries. | Procedure or surgery | Inferior Mesenteric Artery Preservation |
| Inferior Mesenteric Artery LigationAlso: IMA-LPerforming left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery | Procedure or surgery | Inferior Mesenteric Artery Ligation |
Primary outcome
Change from preoperative time in anorectal function
Time frame: 6 and 12 months
We evaluate the presence of modification in anorectal function respect to the preoperative time. This is assessed with specific questionnnaires and anorectal manometry
4 secondary outcomes
Constipation
Time frame: 6 and 12 months
Incontinence
Time frame: 6 and 12 months
Quality of life
Time frame: 6 and 12 months
Postoperative complication
Time frame: 1 month
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 13 Jun 2012.
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 Phase 3 study testing Inferior Mesenteric Artery Preservation and Inferior Mesenteric Artery Ligation in people with Defecatory Disorders After Left Colonic or Rectal Resection, 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 4 inclusion and 5 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 13 Jun 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from preoperative time in anorectal function (time frame: 6 and 12 months). 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 13 Jun 2012.