ConstipationNCT00909116
International Multicenter Prospective Transtar Registry
An observational study of Constipation, run by Ethicon Endo-Surgery (Europe) GmbH at 1 site in Belgium.
Trial summary
Obstructed Defecation Syndrome (ODS) describes a condition which is characterized by chronic constipation. The symptoms of ODS include abdominal pain or cramping, irregular bowel frequency and the feeling of not having emptied the rectum. ODS is usually associated with internal rectal prolapse and/or rectocele. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Stapled Transanal Rectal Resection with Contour Transtar
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jan 2009to 30 Apr 2012
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive male and female patients of at least 16 years with symptoms of chronic constipation due to ODS associated with anatomical changes, such as internal rectal prolapse and rectocele
Who may be able to join
- Patients with obstructed defecation, fragmented defecation or incomplete evacuation as a presenting symptom documented by a standardized symptom score
- confirmed internal rectal prolapse or rectocele on dynamic defecography
- adequate external sphincter on rectal digital examination.
Who cannot join
- Subjects with any other surgical procedure than STARR for ODS
- Subjects in whom STARR is not performed with the Contour Transtar stapler
- Subjects with a physical or psychological condition which would impair participation in the registry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Transtar Registry - Stapled Transanal Rectal Resection Performed With Contour Transtar Stapler in the Treatment of Obstructed Defecation Syndrome (ODS)
Obstructed Defecation Syndrome (ODS) describes a condition which is characterized by chronic constipation. The symptoms of ODS include abdominal pain or cramping, irregular bowel frequency and the feeling of not having emptied the rectum. ODS is usually associated with internal rectal prolapse and/or rectocele. For surgical treatment of ODS, a plethora of surgical techniques have been described with no one method having been assessed as a gold standard.
Read the detailed description
A new surgical procedure - Transtar - has been introduced in Europe recently. The goal of this registry is to assess safety, effectiveness and patient quality of life, associated with Transtar for chronic constipation due to morphological changes, such as internal rectal prolapse and rectocele.
- Conditions
- Constipation
- Being tested
- Stapled Transanal Rectal Resection with Contour Transtar
- Keywords
- ODS, chronic constipation, internal rectal prolapse, rectocele, Stapled Transanal Rectal Resection, Contour Transtar, STARR
- Medical subject headings
- Constipation, Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapled Transanal Rectal Resection with Contour TranstarProcedure or surgery
Transanal Stapling procedure - Stapled Transanal Rectal Resection
| Study group | Role | What they receive |
|---|---|---|
| Chronic constipation - ODS | Adult Patients with ODS Receives: Procedure: Stapled Transanal Rectal Resection with Contour Transtar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in constipation symptoms measured by KESS score
Measured: preoperative, and at 12 months post-op
Secondary outcomes (1)
Changes in patients symptoms measured by Incontinence score and ODS Score, QoL measures with EQ5D and PAC-QoL
Measured: preoperative, at 6 weeks and 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study start31 Jan 2009
- Primary completion30 Apr 2012
- Study completion30 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery (Europe) GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Goran Ribaric, MD,PhD, Study director, Ethicon Endo-Surgery (Europe) GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909116
- Sponsor's protocol ID
- CME-08-001
- Status last verified
- Aug 2017
- First submitted
- 26 May 2009
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: via publication
Publications
Schwandner O, Stuto A, Jayne D, Lenisa L, Pigot F, Tuech JJ, Scherer R, Nugent K, Corbisier F, Basany EE, Hetzer FH. Decision-making algorithm for the STARR procedure in obstructed defecation syndrome: position statement of the group of STARR Pioneers. Surg Innov. 2008 Jun;15(2):105-9. doi: 10.1177/1553350608316684. Epub 2008 Apr 9.
PubMed 18403378Renzi A, Talento P, Giardiello C, Angelone G, Izzo D, Di Sarno G. Stapled trans-anal rectal resection (STARR) by a new dedicated device for the surgical treatment of obstructed defaecation syndrome caused by rectal intussusception and rectocele: early results of a multicenter prospective study. Int J Colorectal Dis. 2008 Oct;23(10):999-1005. doi: 10.1007/s00384-008-0522-0. Epub 2008 Jul 25.
PubMed 18654789
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Transtar Registry - Stapled Transanal Rectal Resection Performed With Contour Transtar Stapler in the Treatment of Obstructed Defecation Syndrome (ODS)
- ClinicalTrials.gov ID
- NCT00909116
- Acronym / sponsor ID
- CME-08-001
- Conditions
- Constipation
- Keywords
- ODS, chronic constipation, internal rectal prolapse, rectocele, Stapled Transanal Rectal Resection, Contour Transtar, STARR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ethicon Endo-Surgery (Europe) GmbHIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2009 (actual)
- Primary completion
- 30 Apr 2012 (actual)
- Study completion
- 30 Apr 2012 (actual)
- First posted
- 27 May 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.
Obstructed Defecation Syndrome (ODS) describes a condition which is characterized by chronic constipation. The symptoms of ODS include abdominal pain or cramping, irregular bowel frequency and the feeling of not having emptied the rectum. ODS is usually associated with internal rectal prolapse and/or rectocele. For surgical treatment of ODS, a plethora of surgical techniques have been described with no one method having been assessed as a gold standard.
Detailed description
A new surgical procedure - Transtar - has been introduced in Europe recently. The goal of this registry is to assess safety, effectiveness and patient quality of life, associated with Transtar for chronic constipation due to morphological changes, such as internal rectal prolapse and rectocele.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic constipation - ODS | – | Procedure: Stapled Transanal Rectal Resection with Contour TranstarAdult Patients with ODS |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive male and female patients of at least 16 years with symptoms of chronic constipation due to ODS associated with anatomical changes, such as internal rectal prolapse and rectocele
Key inclusion criteria (3 listed)
- Patients with obstructed defecation, fragmented defecation or incomplete evacuation as a presenting symptom documented by a standardized symptom score
- confirmed internal rectal prolapse or rectocele on dynamic defecography
- adequate external sphincter on rectal digital examination.
Key exclusion criteria (3 listed)
- Subjects with any other surgical procedure than STARR for ODS
- Subjects in whom STARR is not performed with the Contour Transtar stapler
- Subjects with a physical or psychological condition which would impair participation in the registry.
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 |
|---|---|---|
| Stapled Transanal Rectal Resection with Contour TranstarTransanal Stapling procedure - Stapled Transanal Rectal Resection | Procedure or surgery | Chronic constipation - ODS |
Primary outcome
Change in constipation symptoms measured by KESS score
Time frame: preoperative, and at 12 months post-op
1 secondary outcome
Changes in patients symptoms measured by Incontinence score and ODS Score, QoL measures with EQ5D and PAC-QoL
Time frame: preoperative, at 6 weeks and 12 months post-op
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 11 Aug 2017.
- Background: PubMed 18403378Schwandner O, Stuto A, Jayne D, Lenisa L, Pigot F, Tuech JJ, Scherer R, Nugent K, Corbisier F, Basany EE, Hetzer FH. Decision-making algorithm for the STARR procedure in obstructed defecation syndrome: position statement of the group of STARR Pioneers. Surg Innov. 2008 Jun;15(2):105-9. doi: 10.1177/1553350608316684. Epub 2008 Apr 9.
- Background: PubMed 18654789Renzi A, Talento P, Giardiello C, Angelone G, Izzo D, Di Sarno G. Stapled trans-anal rectal resection (STARR) by a new dedicated device for the surgical treatment of obstructed defaecation syndrome caused by rectal intussusception and rectocele: early results of a multicenter prospective study. Int J Colorectal Dis. 2008 Oct;23(10):999-1005. doi: 10.1007/s00384-008-0522-0. Epub 2008 Jul 25.
- Individual participant dataSharing planned: Yes. via publication
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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.
Goran Ribaric, MD,PhD study director
Ethicon Endo-Surgery (Europe) GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by Ethicon Endo-Surgery (Europe) GmbH at 1 site in Belgium.
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 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 11 Aug 2017. 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 Belgium. 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?
Change in constipation symptoms measured by KESS score (time frame: preoperative, and at 12 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00909116, which also lists 2 linked publications.
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 11 Aug 2017.