Rectocele; FemaleSTARRLOCNCT05037422
Long-term Results of the Stapled Transanal Rectal Resection (STARR) Operation Proposed in the Treatment of a Rectocele
An observational study of Rectocele; Female, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Rectal static disorders, including the rectocele, represent a frequent functional pathology which affects the quality of life of affected patients. Among vaginal treatments, the STARR technique corresponds to rectal resection by transanal approach using a stapler. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectocele; Female
- What is being tested?
- STARR surgery
- Type of treatment
- Surgery or procedure
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2021to 24 Nov 2024
- 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 18 years and older
- Women only
- Adult, Older adult
Study population: All adult patients operated on for rectocele in the digestive surgery and emergency department of the CHU de Grenoble will be included, provided they are not opposed.
Who may be able to join
- Patient operated for rectocele for 10 or more
- Age 18 and over
- Informed patients
Who cannot join
- Patient objection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Grenoble Alpes, Service de chirurgie digestive et de l'urgence
Grenoble
Jean-Luc FAUCHERON, PU-PH, 33476765371, JLFaucheron@chu-grenoble.fr
About this study
Official title: Single-center Retrospective Study of the Long-term Results of the Stapled TransAnal Rectal Resection (STARR) Operation Proposed in the Treatment of a Rectocele in Consecutive Patients
Rectal static disorders, including the rectocele, represent a frequent functional pathology which affects the quality of life of affected patients. Among vaginal treatments, the STARR technique corresponds to rectal resection by transanal approach using a stapler. The American Gastroenterology Association (AGA) has concluded that service to patients is insufficient. The technical and functional results published are mostly short-term studies. The investigators seek to assess the technical and functional results of Operation STARR, based on a series of consecutive expert center cases, to confirm or refute the conclusions of the AGA recommendations.
- Conditions
- Rectocele; Female
- Being tested
- STARR surgery
- Medical subject headings
- Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARR surgeryProcedure or surgery
This intervention is carried out under general anesthesia or spinal anesthesia. It consists of the circular resection of the "surplus" of rectal mucosa. Rectal resection and suturing is performed using automatic mechanical forceps introduced through the anus.
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term results of the STARR operation.
Dyschezia postoperatively
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start16 Oct 2021
- Primary completion24 Oct 2024 (estimated)
- Study completion24 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectocele; FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Faucheron, MD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037422
- Sponsor's protocol ID
- 38RC21.144
- Acronym
- STARRLOC
- Status last verified
- Jan 2024
- First submitted
- 29 Apr 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lehur PA, Stuto A, Fantoli M, Villani RD, Queralto M, Lazorthes F, Hershman M, Carriero A, Pigot F, Meurette G, Narisetty P, Villet R; ODS II Study Group. Outcomes of stapled transanal rectal resection vs. biofeedback for the treatment of outlet obstruction associated with rectal intussusception and rectocele: a multicenter, randomized, controlled trial. Dis Colon Rectum. 2008 Nov;51(11):1611-8. doi: 10.1007/s10350-008-9378-1. Epub 2008 Jul 19.
PubMed 18642046Slim K, Mezoughi S, Launay-Savary MV, Tuech JJ, Michot F, Sielezneff I, Sastre B, Pigot F, Juguet F, Faucheron JL, Voirin D, Chipponi J. [Repair of rectocele using the Stapled TransAnal Rectal Resection (STARR) technique: intermediate results from a multicenter French study]. J Chir (Paris). 2008 Jan-Feb;145(1):27-31. doi: 10.1016/s0021-7697(08)70298-9. French.
PubMed 18438279Gagliardi G, Pescatori M, Altomare DF, Binda GA, Bottini C, Dodi G, Filingeri V, Milito G, Rinaldi M, Romano G, Spazzafumo L, Trompetto M; Italian Society of Colo-Rectal Surgery (SICCR). Results, outcome predictors, and complications after stapled transanal rectal resection for obstructed defecation. Dis Colon Rectum. 2008 Feb;51(2):186-95; discussion 195. doi: 10.1007/s10350-007-9096-0. Epub 2007 Dec 22.
PubMed 18157718Liu WC, Wan SL, Yaseen SM, Ren XH, Tian CP, Ding Z, Zheng KY, Wu YH, Jiang CQ, Qian Q. Transanal surgery for obstructed defecation syndrome: Literature review and a single-center experience. World J Gastroenterol. 2016 Sep 21;22(35):7983-98. doi: 10.3748/wjg.v22.i35.7983.
PubMed 27672293
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Retrospective Study of the Long-term Results of the Stapled TransAnal Rectal Resection (STARR) Operation Proposed in the Treatment of a Rectocele in Consecutive Patients
- ClinicalTrials.gov ID
- NCT05037422
- Acronym / sponsor ID
- STARRLOC / 38RC21.144
- Conditions
- Rectocele; Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 16 Oct 2021 (actual)
- Primary completion
- 24 Oct 2024 (estimated)
- Study completion
- 24 Nov 2024 (estimated)
- First posted
- 8 Sep 2021 (actual)
- 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.
Rectal static disorders, including the rectocele, represent a frequent functional pathology which affects the quality of life of affected patients. Among vaginal treatments, the STARR technique corresponds to rectal resection by transanal approach using a stapler. The American Gastroenterology Association (AGA) has concluded that service to patients is insufficient. The technical and functional results published are mostly short-term studies. The investigators seek to assess the technical and functional results of Operation STARR, based on a series of consecutive expert center cases, to confirm or refute the conclusions of the AGA recommendations.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- All adult patients operated on for rectocele in the digestive surgery and emergency department of the CHU de Grenoble will be included, provided they are not opposed.
Key inclusion criteria (3 listed)
- Patient operated for rectocele for 10 or more
- Age 18 and over
- Informed patients
Key exclusion criteria (1 listed)
- Patient objection
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 |
|---|---|---|
| STARR surgeryThis intervention is carried out under general anesthesia or spinal anesthesia. It consists of the circular resection of the "surplus" of rectal mucosa. Rectal resection and suturing is performed using automatic mechanical forceps introduced through the anus. | Procedure or surgery | – |
Primary outcome
Long term results of the STARR operation.
Time frame: 10 years
Dyschezia postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 18642046Lehur PA, Stuto A, Fantoli M, Villani RD, Queralto M, Lazorthes F, Hershman M, Carriero A, Pigot F, Meurette G, Narisetty P, Villet R; ODS II Study Group. Outcomes of stapled transanal rectal resection vs. biofeedback for the treatment of outlet obstruction associated with rectal intussusception and rectocele: a multicenter, randomized, controlled trial. Dis Colon Rectum. 2008 Nov;51(11):1611-8. doi: 10.1007/s10350-008-9378-1. Epub 2008 Jul 19.
- Background: PubMed 18438279Slim K, Mezoughi S, Launay-Savary MV, Tuech JJ, Michot F, Sielezneff I, Sastre B, Pigot F, Juguet F, Faucheron JL, Voirin D, Chipponi J. [Repair of rectocele using the Stapled TransAnal Rectal Resection (STARR) technique: intermediate results from a multicenter French study]. J Chir (Paris). 2008 Jan-Feb;145(1):27-31. doi: 10.1016/s0021-7697(08)70298-9. French.
- Background: PubMed 18157718Gagliardi G, Pescatori M, Altomare DF, Binda GA, Bottini C, Dodi G, Filingeri V, Milito G, Rinaldi M, Romano G, Spazzafumo L, Trompetto M; Italian Society of Colo-Rectal Surgery (SICCR). Results, outcome predictors, and complications after stapled transanal rectal resection for obstructed defecation. Dis Colon Rectum. 2008 Feb;51(2):186-95; discussion 195. doi: 10.1007/s10350-007-9096-0. Epub 2007 Dec 22.
- Background: PubMed 27672293Liu WC, Wan SL, Yaseen SM, Ren XH, Tian CP, Ding Z, Zheng KY, Wu YH, Jiang CQ, Qian Q. Transanal surgery for obstructed defecation syndrome: Literature review and a single-center experience. World J Gastroenterol. 2016 Sep 21;22(35):7983-98. doi: 10.3748/wjg.v22.i35.7983.
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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.
Jean-Luc Faucheron, MD principal investigator
CHU Grenoble Alpes
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 Rectocele; Female, run by University Hospital, Grenoble 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandrine BARBOIS, MD (0033476765526, sandrinebarbois@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term results of the STARR operation. (time frame: 10 years). 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 NCT05037422, which also lists 4 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 3 Jan 2024.