Obstructed Defecation SyndromeSTARRNCT00673400
Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM
A study testing Stapled transanal rectum resection in people with Obstructed Defecation Syndrome and Rectocele, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new technique has been developed using the new Contour® TranstarTM stapler, which was specifically designed to facilitate the STARR procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstructed Defecation Syndrome, Rectocele, Intussusception
- What is being tested?
- Stapled transanal rectum resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2008to Nov 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Rectocele
- Intussusception
Who cannot join
- Non operability
- inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Surgery, Cantonal Hospital St. Gallen
Sankt Gallen, 9007
About this study
Official title: Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation
The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new technique has been developed using the new Contour® TranstarTM stapler, which was specifically designed to facilitate the STARR procedure. The investigators would like to evaluate the morbidity and quality of life.
- Conditions
- Obstructed Defecation Syndrome, Rectocele, Intussusception, SNS
- Being tested
- Stapled transanal rectum resection
- Keywords
- Obstructed defecation syndrome, ODS, Rectocele, Intussusception, STARR
- Medical subject headings
- Rectocele, Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapled transanal rectum resectionProcedure or surgery
Contour Transtar-STR5G (Ethicon EndoSurgery Inc., Cincinnati, OH).The circular anal dilator is fixed to perianal skin.Rectal intussusception is evidenced with a swab.The first stitch is placed superficial on top of the intussusception. The procedure is performed 5to6 times counterclockwise.A final stitch for first radial cut at 3 o'clock.The device is introduced into the rectum. This cut opens the prolapse. Check with a finger the vagina. The device is then closed and fired. After replacing the cartridge, the device is introduced in the rectum, placed parallel to the circular anal dilator and moved counter clockwise with 4to6firings to complete the resection. Additional stitches across the staple line to assure haemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Stapled transanal rectum resection | Other | patients operated with stapled transanal rectum resection Receives: Procedure: Stapled transanal rectum resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Quality of life is measured by Fecal incontinence quality of life (FIQL)
Possible range of score 0 - 4 (Depression/Self perception 4.4)
0 = worst condition
- Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)
Measured: 6 months after intervention
Secondary outcomes (2)
Morbidity
Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)
Measured: 1 year
Hospitalization
Length of hospital stay (Date of release - Date of admission + 1)
Measured: 1 day to 1 year (until release from hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructed Defecation SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, F. Hetzer, Cantonal Hospital of St. Gallen
- Investigators
- Franc Hetzer, MD, Principal investigator, Cantonal Hospital St. Gallen, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673400
- Sponsor's protocol ID
- STARR
- Acronym
- STARR
- Status last verified
- Oct 2012
- First submitted
- 5 May 2008
- Last updated
- 2 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wolff K, Marti L, Beutner U, Steffen T, Lange J, Hetzer FH. Functional outcome and quality of life after stapled transanal rectal resection for obstructed defecation syndrome. Dis Colon Rectum. 2010 Jun;53(6):881-8. doi: 10.1007/DCR.0b013e3181cdb445.
PubMed 20485001
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation
- ClinicalTrials.gov ID
- NCT00673400
- Acronym / sponsor ID
- STARR / STARR
- Conditions
- Obstructed Defecation Syndrome, Rectocele, Intussusception, SNS
- Keywords
- Obstructed defecation syndrome, ODS, Rectocele, Intussusception, STARR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 2 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new technique has been developed using the new Contour® TranstarTM stapler, which was specifically designed to facilitate the STARR procedure. The investigators would like to evaluate the morbidity and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stapled transanal rectum resection | Other | Procedure: Stapled transanal rectum resectionpatients operated with stapled transanal rectum resection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Rectocele
- Intussusception
Key exclusion criteria (2 listed)
- Non operability
- inflammatory bowel disease
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 rectum resectionContour Transtar-STR5G (Ethicon EndoSurgery Inc., Cincinnati, OH).The circular anal dilator is fixed to perianal skin.Rectal intussusception is evidenced with a swab.The first stitch is placed superficial on top of the intussusception. The procedure is performed 5to6 times counterclockwise.A final stitch for first radial cut at 3 o'clock.The device is introduced into the rectum. This cut opens the prolapse. Check with a finger the vagina. The device is then closed and fired. After replacing the cartridge, the device is introduced in the rectum, placed parallel to the circular anal dilator and moved counter clockwise with 4to6firings to complete the resection. Additional stitches across the staple line to assure haemostasis. | Procedure or surgery | Stapled transanal rectum resection |
Primary outcome
Quality of Life
Time frame: 6 months after intervention
Quality of life is measured by Fecal incontinence quality of life (FIQL) Possible range of score 0 - 4 (Depression/Self perception 4.4) 0 = worst condition * Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)
2 secondary outcomes
Morbidity
Time frame: 1 year
Hospitalization
Time frame: 1 day to 1 year (until release from hospital)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20485001Wolff K, Marti L, Beutner U, Steffen T, Lange J, Hetzer FH. Functional outcome and quality of life after stapled transanal rectal resection for obstructed defecation syndrome. Dis Colon Rectum. 2010 Jun;53(6):881-8. doi: 10.1007/DCR.0b013e3181cdb445.
Related trials for Obstructed Defecation Syndrome
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Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial
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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.
Franc Hetzer, MD principal investigator
Cantonal Hospital St. Gallen, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stapled transanal rectum resection in people with Obstructed Defecation Syndrome and Rectocele, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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 2 inclusion and 2 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 Oct 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 2 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quality of Life (time frame: 6 months after intervention). 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 NCT00673400, which also lists 1 linked publication.
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 Oct 2012.