Gastric Outlet ObstructionPhase 4ODS IINCT00556283
RCT: STARR vs Biofeedback
A Phase 4 study testing STARR and Biofeedback in people with Gastric Outlet Obstruction and Rectocele, run by Ethicon Endo-Surgery (Europe) GmbH at 9 sites in 3 countries.
Trial summary
This study aimed to evaluate the safety and symptomatic outcomes achieved with Stapled Transanal Rectal Resection (STARR) compared to biofeedback training in patients with obstructed defecation syndrome (ODS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gastric Outlet Obstruction, Rectocele, Intussusception
- What is being tested?
- STARR and Biofeedback
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Feb 2004to May 2007
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients >18 years old
- Able to comprehend, follow, and provide written informed consent.
- Minimum ODS Score of seven at screening.
- Negative pregnancy test, by urine.
- 'Obstructed' defecation requiring straining/digitation as presenting lead symptom.
- Adequate external sphincter on rectal digital examination.
- Evidence of anterior rectocele and/or rectal intussusception on dynamic defecography. (Note: dynamic defecography taken within 12 months will be acceptable)
- Willingness to comply with study requirements including follow-up visits
Who cannot join
- Evidence of external sphincter injury associated with incontinence.
- Enterocele at rest- requiring surgery.
- Faecal incontinence (soiling and faecal urgency is admissible).
- Any anterior defect, colpocele or cystocele requiring a combined surgical approach.
- Physical or psychological condition which would impair participation in the study.
- Participation in any other device or drug study within 90 days prior to enrollment.
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- Planned participation in any other device study during the timeframe of this study.
- General contraindication for surgery.
- Previous transanal surgery for ODS.
- Immunocompromised subjects
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
France5 sites
Chirurgie Proctologique
Besançon, 25000
Clinique des Cèdres
Cornebarrieu, 31700
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, 75012
Hopital Bagatelle
Talence, 33401
CHU Purpan
Toulouse, 31055
Italy3 sites
Ospedale S. Giuseppe
Milan, 20123
Ospedale "Franchini" di Montecchio Emilia
Montecchio Emilia, 42027
Ospedale Santa Maria degli Angeli
Pordenone, 33170
United Kingdom1 site
Royal Liverpool University Hospital
Liverpool, L7 8XP
About this study
Official title: Outcomes of Stapled Trans-Anal Rectal Resection (STARR) vs. Biofeedback in the Treatment of Outlet Obstruction Associated With Rectal Intussusception and Rectocele: A Multi-center Randomized Controlled Trial
This study aimed to evaluate the safety and symptomatic outcomes achieved with Stapled Transanal Rectal Resection (STARR) compared to biofeedback training in patients with obstructed defecation syndrome (ODS).
- Conditions
- Gastric Outlet Obstruction, Rectocele, Intussusception, Anismus
- Being tested
- STARR, Biofeedback
- Keywords
- outlet obstruction, rectocele
- Medical subject headings
- Gastric Outlet Obstruction, Rectocele, Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARRDevice
Stapled Trans-Anal Rectal Resection for the treatment of ODS
BiofeedbackBehavioural
electromyographic-based treatment sessions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | STARR Receives: Device: STARR |
| 2 | Active comparator | Biofeedback Receives: Behavioral: Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODS total score
Measured: 12 months
Secondary outcomes (1)
PAC-QoL score
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 posted9 Nov 2007 (estimated)
- Study startFeb 2004
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Outlet ObstructionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery (Europe) GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aysgarth Statistics, Physicians World GmbH
- Investigators
- Paul A Lehur, MD, Principal investigator, Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, 1 place A Ricordeau, F-44093 Nantes Cedex 01Goran Ribaric, MD, PhD, Study director, Ethicon Endo-Surgery (Europe) GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556283
- Sponsor's protocol ID
- ODS-HJH-4
- Acronym
- ODS II
- Status last verified
- Dec 2013
- First submitted
- 8 Nov 2007
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Stapled Trans-Anal Rectal Resection (STARR) vs. Biofeedback in the Treatment of Outlet Obstruction Associated With Rectal Intussusception and Rectocele: A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00556283
- Acronym / sponsor ID
- ODS II / ODS-HJH-4
- Conditions
- Gastric Outlet Obstruction, Rectocele, Intussusception, Anismus
- Keywords
- outlet obstruction, rectocele
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Ethicon Endo-Surgery (Europe) GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Aysgarth Statistics, Physicians World GmbH
- Study start
- Feb 2004
- Study completion
- May 2007 (actual)
- First posted
- 9 Nov 2007 (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.
This study aimed to evaluate the safety and symptomatic outcomes achieved with Stapled Transanal Rectal Resection (STARR) compared to biofeedback training in patients with obstructed defecation syndrome (ODS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: STARRSTARR |
| 2 | Active comparator | Behavioral: BiofeedbackBiofeedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients >18 years old
- Able to comprehend, follow, and provide written informed consent.
- Minimum ODS Score of seven at screening.
- Negative pregnancy test, by urine.
- 'Obstructed' defecation requiring straining/digitation as presenting lead symptom.
Key exclusion criteria (10 listed)
- Evidence of external sphincter injury associated with incontinence.
- Enterocele at rest- requiring surgery.
- Faecal incontinence (soiling and faecal urgency is admissible).
- Any anterior defect, colpocele or cystocele requiring a combined surgical approach.
- Physical or psychological condition which would impair participation in the study.
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 |
|---|---|---|
| STARRStapled Trans-Anal Rectal Resection for the treatment of ODS | Device | 1 |
| Biofeedbackelectromyographic-based treatment sessions | Behavioural | 2 |
Primary outcome
ODS total score
Time frame: 12 months
1 secondary outcome
PAC-QoL score
Time frame: 12 months
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 18 Dec 2013.
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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.
Paul A Lehur, MD principal investigator
Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, 1 place A Ricordeau, F-44093 Nantes Cedex 01
Goran Ribaric, MD, PhD study director
Ethicon Endo-Surgery (Europe) GmbH
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing STARR and Biofeedback in people with Gastric Outlet Obstruction and Rectocele, run by Ethicon Endo-Surgery (Europe) GmbH at 9 sites in 3 countries.
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 8 inclusion and 10 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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Italy, United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
ODS total score (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 18 Dec 2013; AzTrials last refreshed its copy on 27 Oct 2026.