Sensation of Inadequate DefecationPRO-RESTNCT01899209
Surgical Treatment of Obstructed Defecation Syndrome
A study testing STARR and Laparoscopic Ventral Rectopexy in people with Sensation of Inadequate Defecation and Rectal Prolapse, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures has been introduced to treat patients affected by this disease. The most used are STARR and ventral rectopexy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensation of Inadequate Defecation, Rectal Prolapse, Rectocele
- What is being tested?
- STARR and Laparoscopic Ventral Rectopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2013to Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients affected by Obstructed Defecation with ODS score >11
- Symptomatic rectal Intussusception and/or defecographic finding of rectocele>2 cm
- Failure of at least 6 months of medical therapy
Who cannot join
- Patients affected by complete rectal prolapse
- Patients affected by slow transit constipation
- Patients affected by anismus
- Patients affected by pelvic organ prolapse
- Patients with previous rectal or anal surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Hospital
Bologna, Bologna, 40138
Dajana Cuicchi, MD PhD, 0516363236 ext. 0039, cuicchidajana@yahoo.it
Dajana Cuicchi, MD PhD
About this study
Official title: Obstructed Defecation Caused by Rectal Intussusception and Rectocele:STARR Versus Laparoscopic Ventral Rectopexy
Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures has been introduced to treat patients affected by this disease. The most used are STARR and ventral rectopexy. Because of the heterogenity of studies and overall the lack of comparison trials, there is no accepted standard surgical treatment.PRO-REST aimed to compare these two procedures (STARR and Ventral Rectopexy) evaluating functional and anatomical results.
- Being tested
- STARR, Laparoscopic Ventral Rectopexy
- Keywords
- Obstructed Defecation, Rectal rectocele, Intussusception, STARR, Ventral Rectopexy
- Medical subject headings
- Rectal Prolapse, Rectocele, Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARRProcedure or surgery
Laparoscopic Ventral RectopexyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | STARR Receives: Procedure: STARR |
| Group B | Experimental | Laparoscopic ventral Rectopexy Receives: Procedure: Laparoscopic Ventral Rectopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional result
comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery
Measured: 12 months
Secondary outcomes (1)
Anatomical result
Comparison of clinical and radiological data before and 12 months after surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensation of Inadequate DefecationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna
- Responsible party
- Principal investigator, Dajana Cuicchi, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899209
- Sponsor's protocol ID
- PRO-REST
- Acronym
- PRO-REST
- Status last verified
- Jun 2014
- First submitted
- 8 Jul 2013
- Last updated
- 27 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructed Defecation Caused by Rectal Intussusception and Rectocele:STARR Versus Laparoscopic Ventral Rectopexy
- ClinicalTrials.gov ID
- NCT01899209
- Acronym / sponsor ID
- PRO-REST / PRO-REST
- Keywords
- Obstructed Defecation, Rectal rectocele, Intussusception, STARR, Ventral Rectopexy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- University of Bologna
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (estimated)
- First posted
- 15 Jul 2013 (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.
Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures has been introduced to treat patients affected by this disease. The most used are STARR and ventral rectopexy. Because of the heterogenity of studies and overall the lack of comparison trials, there is no accepted standard surgical treatment.PRO-REST aimed to compare these two procedures (STARR and Ventral Rectopexy) evaluating functional and anatomical results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: STARRSTARR |
| Group B | Experimental | Procedure: Laparoscopic Ventral RectopexyLaparoscopic ventral Rectopexy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients affected by Obstructed Defecation with ODS score >11
- Symptomatic rectal Intussusception and/or defecographic finding of rectocele>2 cm
- Failure of at least 6 months of medical therapy
Key exclusion criteria (5 listed)
- Patients affected by complete rectal prolapse
- Patients affected by slow transit constipation
- Patients affected by anismus
- Patients affected by pelvic organ prolapse
- Patients with previous rectal or anal surgery
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 |
|---|---|---|
| STARR | Procedure or surgery | Group A |
| Laparoscopic Ventral Rectopexy | Procedure or surgery | Group B |
Primary outcome
Functional result
Time frame: 12 months
comparison between Obstructed Defaecation Syndrome (ODS) score before and 12 months after surgery
1 secondary outcome
Anatomical result
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STARR and Laparoscopic Ventral Rectopexy in people with Sensation of Inadequate Defecation and Rectal Prolapse, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 3 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: status not confirmed, as of the sponsor's last update on 27 Jun 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dajana Cuicchi, MD PhD (0516363236 ext. 0039, dajana.cuicchi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional result (time frame: 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 27 Jun 2014.