Rectal ProlapsePhase 4NCT00810745
What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation?
A Phase 4 study testing starr in people with Rectal Prolapse, run by University of Milan at 2 sites in Italy.
Trial summary
This randomized study was designed to compare the 2 year clinical and functional results with the STARR procedure using a new curved cutter stapler or the same operation done with 2 traditional circular staplers. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- starr
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2006to Nov 2008
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rectal prolapse
- Rectocele
- ODS score > 15
- Continence score < 3
- Resting pressure > 40 mm/Hg
Who cannot join
- Previous anorectal surgery
- Ods score < 15
- Continence score > 3
- Resting pressure < 40
- Concomitant pelvic floor diseases
- Psychiatric diseases
- Absolute contraindications to surgery
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
First department of general surgery university of milan
Milan, 20122
First Department of General Surgery
Milan, 20122
About this study
Official title: What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation? Two-Year Outcomes From a Randomized Controlled Trial
This randomized study was designed to compare the 2 year clinical and functional results with the STARR procedure using a new curved cutter stapler or the same operation done with 2 traditional circular staplers.
Read the detailed description
From January to November 2006, 80 women were selected, with clinical examination, constipation score, colonoscopy, anorectal manometry, and perineography and randomly assigned to 2 groups: 40 patients underwent stapled transanal rectal resection with two staplers PPH-01 (Ethicon Endosurgery Inc, Pomezia, Italy) (STARR group) and 40 had the same operation with new, curved multi-fire stapler Contour R Transtar TM (TRANSTAR group). Patients were followed up with clinical examination, constipation score, and perineography.
- Conditions
- Rectal Prolapse
- Being tested
- starr
- Keywords
- ODS, stapled transanal rectal resection
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
starrProcedure or surgery
stapled transanal rectal resection
| Study group | Role | What they receive |
|---|---|---|
| rectal resection | Experimental | Not described Receives: Procedure: starr |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of recurrences
Measured: 2 years
Secondary outcomes (1)
outcomes on symptoms and defecography
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startJan 2006
- Primary completionSep 2008
- Study completionNov 2008
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Investigators
- paolo boccasanta, md, Principal investigator, 1 department of general surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810745
- Sponsor's protocol ID
- starr
- Status last verified
- Feb 2009
- First submitted
- 17 Dec 2008
- Last updated
- 26 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation? Two-Year Outcomes From a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00810745
- Acronym / sponsor ID
- starr
- Conditions
- Rectal Prolapse
- Keywords
- ODS, stapled transanal rectal resection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Dec 2008 (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 randomized study was designed to compare the 2 year clinical and functional results with the STARR procedure using a new curved cutter stapler or the same operation done with 2 traditional circular staplers.
Detailed description
From January to November 2006, 80 women were selected, with clinical examination, constipation score, colonoscopy, anorectal manometry, and perineography and randomly assigned to 2 groups: 40 patients underwent stapled transanal rectal resection with two staplers PPH-01 (Ethicon Endosurgery Inc, Pomezia, Italy) (STARR group) and 40 had the same operation with new, curved multi-fire stapler Contour R Transtar TM (TRANSTAR group). Patients were followed up with clinical examination, constipation score, and perineography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rectal resection | Experimental | Procedure: starr |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Rectal prolapse
- Rectocele
- ODS score > 15
- Continence score < 3
- Resting pressure > 40 mm/Hg
Key exclusion criteria (7 listed)
- Previous anorectal surgery
- Ods score < 15
- Continence score > 3
- Resting pressure < 40
- Concomitant pelvic floor 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 |
|---|---|---|
| starrstapled transanal rectal resection | Procedure or surgery | rectal resection |
Primary outcome
incidence of recurrences
Time frame: 2 years
1 secondary outcome
outcomes on symptoms and defecography
Time frame: 2 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 26 Feb 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.
paolo boccasanta, md principal investigator
1 department of general surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing starr in people with Rectal Prolapse, run by University of Milan at 2 sites 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 5 inclusion and 7 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 26 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
incidence of recurrences (time frame: 2 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 26 Feb 2009.