RectoceleNCT02659176
Trans-perineal Repair With or Without Limited Internal Sphincterotomy for Treatment of Type I Anterior Rectocele
A study testing Transperineal repair with PIS and Transperineal repair without PIS in people with Rectocele, run by Mansoura University at 1 site in Egypt.
Trial summary
Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Rectocele
- What is being tested?
- Transperineal repair with PIS and Transperineal repair without PIS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2011to Feb 2016
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with anterior rectocele
Who cannot join
- Pregnant females
- Rectocele with pelvic organ prolapse
- Any patient with previous anorectal surgery
- Pudendal nerve neuropathy
- Anal fistula and sepsis
- Patients with sphincter defect proved by endo-anal sonography
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- Patients proved to have colonic inertia either by colon transit time and/or history
- Patients with defecography anomalies causing obstructed defecation other than rectocele (e.g. Anismus).
- Also patients with vascular diseases, scleroderma, malnutrition, and coagulopathy were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Trans-perineal Repair With or Without Limited Internal Sphincterotomy in Treatment of Type I Anterior Rectocele: A Randomized Controlled Trial
Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.
Read the detailed description
Transperineal repair of anterior rectocele is performed in two groups of patients, the first will undergo limited posterior internal sphincterotomy, the second group will not have internal sphincteroromy. The two groups are compared regarding recurrence of rectocele and improvement of symptoms.
- Conditions
- Rectocele
- Being tested
- Transperineal repair with PIS, Transperineal repair without PIS
- Medical subject headings
- Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal repair with PISProcedure or surgery
Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.
Transperineal repair without PISProcedure or surgery
Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy
| Study group | Role | What they receive |
|---|---|---|
| Transperineal repair with PIS | Active comparator | transperineal repair of anterior rectocele with limited internal sphincterotomy Receives: Procedure: Transperineal repair with PIS |
| Transperineal repair without PIS | Active comparator | transperineal repair of anterior rectocele only Receives: Procedure: Transperineal repair without PIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrence
Number of patients presenting with recurrent or persistent symptoms during follow up
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2011
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RectoceleStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Mohamed Youssef, M.D, Principal investigator, Mansoura Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659176
- Sponsor's protocol ID
- mansoura31
- Status last verified
- Mar 2016
- First submitted
- 15 Jan 2016
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Trans-perineal Repair With or Without Limited Internal Sphincterotomy in Treatment of Type I Anterior Rectocele: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02659176
- Acronym / sponsor ID
- mansoura31
- Conditions
- Rectocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Jan 2016 (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.
Comparison between transperineal repair of rectocele with or without posterior internal sphincterotomy.
Detailed description
Transperineal repair of anterior rectocele is performed in two groups of patients, the first will undergo limited posterior internal sphincterotomy, the second group will not have internal sphincteroromy. The two groups are compared regarding recurrence of rectocele and improvement of symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transperineal repair with PIS | Active comparator | Procedure: Transperineal repair with PIStransperineal repair of anterior rectocele with limited internal sphincterotomy |
| Transperineal repair without PIS | Active comparator | Procedure: Transperineal repair without PIStransperineal repair of anterior rectocele only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with anterior rectocele
Key exclusion criteria (9 listed)
- Pregnant females
- Rectocele with pelvic organ prolapse
- Any patient with previous anorectal surgery
- Pudendal nerve neuropathy
- Anal fistula and sepsis
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 |
|---|---|---|
| Transperineal repair with PISRepair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock. | Procedure or surgery | Transperineal repair with PIS |
| Transperineal repair without PISRepair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy | Procedure or surgery | Transperineal repair without PIS |
Primary outcome
Incidence of recurrence
Time frame: 18 months
Number of patients presenting with recurrent or persistent symptoms during follow up
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 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Rectocele
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Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
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Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
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Enrolling by invitationObservational study
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
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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.
Mohamed Youssef, M.D principal investigator
Mansoura Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transperineal repair with PIS and Transperineal repair without PIS in people with Rectocele, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 9 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 Mar 2016. 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 Egypt. 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?
Incidence of recurrence (time frame: 18 months). 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 16 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.