RectoceleCompli-STARRNCT02052063
Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?
A study testing stapled transanal rectal resection and Anal compliance measure with Endoflip system in people with Rectocele and Intussusception, run by University Hospital, Rouen at 1 site in France.
Trial summary
The stapled transanal rectal resection (STARR) has recently been recommended for patients with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall intussusception. The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Rectocele, Intussusception, Surgery
- What is being tested?
- stapled transanal rectal resection and Anal compliance measure with Endoflip system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2014to 5 Sep 2018
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years old
- Patient is not under any type of guardianship
- Patient has a rectocele > 3 cm during defecography
- Patient has persistent defecatory troubles despite medical treatment (laxatives for at least 1 month)
- Patient received information and signed the consent form
- Patients having social security coverage
Who cannot join
- Patient has an asymptomatic rectocele
- Patient with an enterocele at rest upon defecography, with opacification of the small bowel
- Faecal incontinence
- Anal sphincter insufficiency detected by rectal manometry
- Patient with non-rehabilitated anorectal asynchrony
- Patient has previously had rectal surgery or pelvic radiotherapy
Show all 16Show fewer
- Patient has a anal or rectal lesion, intestinal inflammatory disease
- Anal or rectal tumor
- Immunocompromised subjects
- Positive pregnancy test, by urine
- Psychological condition which would impair participation in the study
- Coagulation disorders
- Patients using anticoagulants
- Participation in any other device or drug study within 30 days prior to enrollment.
- Patient cannot read French
- Patient is under any type of guardianship
Trial locations and contacts
1 site in 1 country.
About this study
The stapled transanal rectal resection (STARR) has recently been recommended for patients with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall intussusception.
The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum.
Read more
This technique significantly improves constipation. However, there are several reports of new-onset faecal incontinence after STARR and urgency has been identified as the major side-effect of this procedure.
Although this technique has become an important surgical option in the treatment of obstructive defaecation syndrome, its impact on continence can be problematic and objective data about parameters that predict its result are not yet available One study evaluated the anal function after surgery in 30 patients. In this study, urgency or incontinence was complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were noticed in the endoanal exam performed at the follow-up.
No significant difference was observed in anorectal manometry. Even if data are not statistically significant, resting and squeezing pressures are lower in those patients not satisfied.
Currently, anal canal pressure measurements using ano-rectal manometry are the most common means of assessment of sphincter function. Some studies have been looking at the concept of distending sphincter regions as a better measure of its performance.
The functional lumen imaging probe (FLIP) is a novel technique which has the ability to provide real-time images of the function of human gastrointestinal sphincter during distension. This distensibility technique provides an important new way of studying the anal canal and hence may have a role in testing sphincter competence in patients with disorders after STARR procedure.
Twenty-eight patients will be enrolled in this study over a period of 36 months.
Preoperative assessment will include
- clinical examination
- the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL) to rate anal incontinence
- video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months after surgery, and will include symptom evaluation (using the same standard questionnaires for incontinence), clinical examination and investigation using anal ultrasound and endoFLIP.
If we demonstrate that this surgical technique can cause anal lesions with decreased sphincter competence, this may lead to a modification of the surgical technique especially in patients at risk of developing postoperative anal incontinence.
- Conditions
- Rectocele, Intussusception, Surgery, Sphincter Ani Incontinence
- Being tested
- stapled transanal rectal resection, Anal compliance measure with Endoflip system
- Keywords
- rectocele, intussusception, surgery
- 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 rectal resectionDevice
Also called transanal rectal resection using staple
transanal rectal resection using staple will be done for rectocele
Anal compliance measure with Endoflip systemDevice
Anal compliance will be measured using Endoflip system
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Patient who undergone stapled transanal rectal resection for rectocele. Anal compliance will be evaluated before and starting the surgery using endoflip system Receives: Device: stapled transanal rectal resection; Device: Anal compliance measure with Endoflip system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of anal sphincter distensibility
Comparison of anal sphincter distensibility before and 3 months after surgery with cross-sectional area and intra-balloon pressure.
The device used is Endoflip system
Measured: Month 3
Secondary outcomes (3)
Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery
Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery
Measured: Month 3
Comparison of radiological data (Anal ultrasound)
Comparison of radiological data (Anal ultrasound) before and 3 months after surgery Endo-rectal Brüel and Kjaer echographic probe will be used to compare radiological data (conventional endo-rectal echography)
Measured: Month 3
Comparison of Cleveland Clinic Incontinence score (CCIS) before and 3 months after surgery
Comparison between Cleveland Clinic Incontinence score (CCIS)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study start5 Sep 2014
- Primary completion5 Sep 2018
- Study completion5 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RectoceleStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie BRIDOUX, MD, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052063
- Sponsor's protocol ID
- 2013/132/HP
- Acronym
- Compli-STARR
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2014
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Desprez C, Melchior C, Gourcerol G, Tuech JJ, Houivet E, Leroi AM, Bridoux V. Assessment of anal sphincter distensibility following the STARR procedure: a pilot study. Acta Chir Belg. 2020 Jun;120(3):198-201. doi: 10.1080/00015458.2019.1693156. Epub 2019 Nov 21.
PubMed 31738687
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?
- ClinicalTrials.gov ID
- NCT02052063
- Acronym / sponsor ID
- Compli-STARR / 2013/132/HP
- Conditions
- Rectocele, Intussusception, Surgery, Sphincter Ani Incontinence
- Keywords
- rectocele, intussusception, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 5 Sep 2014 (actual)
- Primary completion
- 5 Sep 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 31 Jan 2014 (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.
The stapled transanal rectal resection (STARR) has recently been recommended for patients with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall intussusception.
The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum.
This technique significantly improves constipation. However, there are several reports of new-onset faecal incontinence after STARR and urgency has been identified as the major side-effect of this procedure.
Although this technique has become an important surgical option in the treatment of obstructive defaecation syndrome, its impact on continence can be problematic and objective data about parameters that predict its result are not yet available One study evaluated the anal function after surgery in 30 patients. In this study, urgency or incontinence was complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were noticed in the endoanal exam performed at the follow-up.
No significant difference was observed in anorectal manometry. Even if data are not statistically significant, resting and squeezing pressures are lower in those patients not satisfied.
Currently, anal canal pressure measurements using ano-rectal manometry are the most common means of assessment of sphincter function. Some studies have been looking at the concept of distending sphincter regions as a better measure of its performance.
The functional lumen imaging probe (FLIP) is a novel technique which has the ability to provide real-time images of the function of human gastrointestinal sphincter during distension. This distensibility technique provides an important new way of studying the anal canal and hence may have a role in testing sphincter competence in patients with disorders after STARR procedure.
Twenty-eight patients will be enrolled in this study over a period of 36 months.
Preoperative assessment will include
- clinical examination
- the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL) to rate anal incontinence
- video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months after surgery, and will include symptom evaluation (using the same standard questionnaires for incontinence), clinical examination and investigation using anal ultrasound and endoFLIP.
If we demonstrate that this surgical technique can cause anal lesions with decreased sphincter competence, this may lead to a modification of the surgical technique especially in patients at risk of developing postoperative anal incontinence.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Device: stapled transanal rectal resection, Device: Anal compliance measure with Endoflip systemPatient who undergone stapled transanal rectal resection for rectocele. Anal compliance will be evaluated before and starting the surgery using endoflip system |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients >18 years old
- Patient is not under any type of guardianship
- Patient has a rectocele > 3 cm during defecography
- Patient has persistent defecatory troubles despite medical treatment (laxatives for at least 1 month)
- Patient received information and signed the consent form
Key exclusion criteria (16 listed)
- Patient has an asymptomatic rectocele
- Patient with an enterocele at rest upon defecography, with opacification of the small bowel
- Faecal incontinence
- Anal sphincter insufficiency detected by rectal manometry
- Patient with non-rehabilitated anorectal asynchrony
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 resectionAlso: transanal rectal resection using stapletransanal rectal resection using staple will be done for rectocele | Device | Surgery |
| Anal compliance measure with Endoflip systemAnal compliance will be measured using Endoflip system | Device | Surgery |
Primary outcome
Comparison of anal sphincter distensibility
Time frame: Month 3
Comparison of anal sphincter distensibility before and 3 months after surgery with cross-sectional area and intra-balloon pressure. The device used is Endoflip system
3 secondary outcomes
Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery
Time frame: Month 3
Comparison of radiological data (Anal ultrasound)
Time frame: Month 3
Comparison of Cleveland Clinic Incontinence score (CCIS) before and 3 months after surgery
Time frame: Month 3
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 16 Apr 2026.
- Results publication: PubMed 31738687Desprez C, Melchior C, Gourcerol G, Tuech JJ, Houivet E, Leroi AM, Bridoux V. Assessment of anal sphincter distensibility following the STARR procedure: a pilot study. Acta Chir Belg. 2020 Jun;120(3):198-201. doi: 10.1080/00015458.2019.1693156. Epub 2019 Nov 21.
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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.
Valérie BRIDOUX, MD principal investigator
UH Rouen
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 rectal resection and Anal compliance measure with Endoflip system in people with Rectocele and Intussusception, run by University Hospital, Rouen at 1 site in France.
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 6 inclusion and 16 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 16 Apr 2026. 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 France. 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?
Comparison of anal sphincter distensibility (time frame: Month 3). 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 NCT02052063, 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 16 Apr 2026.