Rectal ProlapsePhase 3BergamaschiNCT01022034
Pexy Versus Non-pexy for Full Thickness Rectal Prolapse
A Phase 3 study testing sacral rectopexy with sutures or meshes and full rectal mobilization from the sacrum without sacral rectopexy in people with Rectal Prolapse, run by Societa Italiana di Chirurgia ColoRettale at 1 site in United States.
Trial summary
No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external full-thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- sacral rectopexy with sutures or meshes and full rectal mobilization from the sacrum without sacral rectopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Oct 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- mental ability to understand the procedure
- age range 18 to 70
- both sex
Who cannot join
- patients with recurrent rectal prolapse
- previous pelvic or colorectal surgery
- previous operation for fecal incontinence
- Cancer
- chronic intestinal Inflammatory diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony brook University
New York, New York, 11794-3368
About this study
Official title: Pexy vs. No Pexy in Abdominal Surgery for Full Thickness Rectal Prolapse in Adults: A Randomized Controlled Trial
No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external full-thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy.
Method: This is a multicenter randomized non-inferiority trial. Eligible patients were randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery with mobilization and pexy. Sigmoid resection was not randomized and was added in the presence of constipation. The endpoint was recurrence rates defined as presence of external FTRP after surgery. A pre-RCT meta-analysis suggested a sample size of 251 patients based on a 15% expected difference in the 5-year cumulative recurrence rate. Recurrence-free curves will be generated and compared using the Kaplan-Meier method and log-rank test, respectively. A Bonferroni adjustment was used. An adjusted p value of <0.01 was considered significant.
- Conditions
- Rectal Prolapse
- Being tested
- sacral rectopexy with sutures or meshes, full rectal mobilization from the sacrum without sacral rectopexy
- Keywords
- Rectal prolapse, mesh, recurrence
- Medical subject headings
- Rectal Prolapse, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacral rectopexy with sutures or meshesProcedure or surgery
full rectal mobilization from the sacrum without sacral rectopexyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pexy group | Active comparator | This group of patients with full thickness rectal prolapse will receive standard sacral rectopexy with mesh or sutures Receives: Procedure: sacral rectopexy with sutures or meshes |
| Non-pexy group | Sham comparator | These patients will receive full rectal mobilization from the sacrum but without rectopexy Receives: Procedure: full rectal mobilization from the sacrum without sacral rectopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
long term recurrence of the rectal prolapse
Measured: after 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startJan 2003
- Primary completionJan 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettale
- Sponsor type
- Research network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022034
- Sponsor's protocol ID
- Berg.2007
- Acronym
- Bergamaschi
- Status last verified
- Dec 2009
- First submitted
- 25 Nov 2009
- Last updated
- 2 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pexy vs. No Pexy in Abdominal Surgery for Full Thickness Rectal Prolapse in Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01022034
- Acronym / sponsor ID
- Bergamaschi / Berg.2007
- Conditions
- Rectal Prolapse
- Keywords
- Rectal prolapse, mesh, recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Societa Italiana di Chirurgia ColoRettaleResearch network
- Study start
- Jan 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 1 Dec 2009 (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.
No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external full-thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy.
Method: This is a multicenter randomized non-inferiority trial. Eligible patients were randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery with mobilization and pexy. Sigmoid resection was not randomized and was added in the presence of constipation. The endpoint was recurrence rates defined as presence of external FTRP after surgery. A pre-RCT meta-analysis suggested a sample size of 251 patients based on a 15% expected difference in the 5-year cumulative recurrence rate. Recurrence-free curves will be generated and compared using the Kaplan-Meier method and log-rank test, respectively. A Bonferroni adjustment was used. An adjusted p value of <0.01 was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pexy group | Active comparator | Procedure: sacral rectopexy with sutures or meshesThis group of patients with full thickness rectal prolapse will receive standard sacral rectopexy with mesh or sutures |
| Non-pexy group | Sham comparator | Procedure: full rectal mobilization from the sacrum without sacral rectopexyThese patients will receive full rectal mobilization from the sacrum but without rectopexy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed consent
- mental ability to understand the procedure
- age range 18 to 70
- both sex
Key exclusion criteria (5 listed)
- patients with recurrent rectal prolapse
- previous pelvic or colorectal surgery
- previous operation for fecal incontinence
- Cancer
- chronic intestinal Inflammatory diseases
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 |
|---|---|---|
| sacral rectopexy with sutures or meshes | Procedure or surgery | Pexy group |
| full rectal mobilization from the sacrum without sacral rectopexy | Procedure or surgery | Non-pexy group |
Primary outcome
long term recurrence of the rectal prolapse
Time frame: after 5 years
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 2 Dec 2009.
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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 sacral rectopexy with sutures or meshes and full rectal mobilization from the sacrum without sacral rectopexy in people with Rectal Prolapse, run by Societa Italiana di Chirurgia ColoRettale at 1 site in United States.
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 2 Dec 2009. 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 United States. 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. Some participants in this study may receive a placebo. 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?
long term recurrence of the rectal prolapse (time frame: after 5 years). 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 2 Dec 2009.