RectoceleNCT03801291
Transvaginal Versus Transperineal Repair of Rectocele
A study testing Transvaginal repair and Transperineal repair in people with Rectocele, run by Mansoura University at 1 site in Egypt.
Trial summary
Patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. The primary outcome of the study was improvement in constipation at 6 and 12 months Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Rectocele
- What is being tested?
- Transvaginal repair and Transperineal repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2016to 7 Jan 2019
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients with anterior rectocele
Who cannot join
- Male patients.
- Combined rectocele with internal rectal prolapse.
- Anismus.
- Associated anorectal condition such as hemorrhoids and anal fissure.
- Pregnancy.
- Unwilling to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transvaginal Versus Transperineal Repair of Anterior Rectocele: a Randomized Controlled Trial
Patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. The primary outcome of the study was improvement in constipation at 6 and 12 months
- Conditions
- Rectocele
- Being tested
- Transvaginal repair, Transperineal repair
- Medical subject headings
- Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal repairProcedure or surgery
Vaginal incision through which plication of the rectovaginal septum is done
Transperineal repairProcedure or surgery
Perineal incision through which plication of the rectovaginal septum is done
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal repair | Active comparator | Repair of anterior rectocele via the vagina Receives: Procedure: Transvaginal repair |
| Transperineal repair | Active comparator | Repair of anterior rectocele via the perineum Receives: Procedure: Transperineal repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in constipation
decrease in Wexner constipation score by 25%
Measured: 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start1 Apr 2016
- Primary completion1 Jul 2018
- Study completion7 Jan 2019
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.
- 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, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03801291
- Sponsor's protocol ID
- masnoura99
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Balata M, Elgendy H, Emile SH, Youssef M, Omar W, Khafagy W. Functional Outcome and Sexual-Related Quality of Life After Transperineal Versus Transvaginal Repair of Anterior Rectocele: A Randomized Clinical Trial. Dis Colon Rectum. 2020 Apr;63(4):527-537. doi: 10.1097/DCR.0000000000001595.
PubMed 31996580
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Versus Transperineal Repair of Anterior Rectocele: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03801291
- Acronym / sponsor ID
- masnoura99
- Conditions
- Rectocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 11 Jan 2019 (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.
Patients with anterior rectocele were randomized to undergo either transvaginal or transperineal repair. The primary outcome of the study was improvement in constipation at 6 and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal repair | Active comparator | Procedure: Transvaginal repairRepair of anterior rectocele via the vagina |
| Transperineal repair | Active comparator | Procedure: Transperineal repairRepair of anterior rectocele via the perineum |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult female patients with anterior rectocele
Key exclusion criteria (6 listed)
- Male patients.
- Combined rectocele with internal rectal prolapse.
- Anismus.
- Associated anorectal condition such as hemorrhoids and anal fissure.
- Pregnancy.
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 |
|---|---|---|
| Transvaginal repairVaginal incision through which plication of the rectovaginal septum is done | Procedure or surgery | Transvaginal repair |
| Transperineal repairPerineal incision through which plication of the rectovaginal septum is done | Procedure or surgery | Transperineal repair |
Primary outcome
Improvement in constipation
Time frame: 6 and 12 months after surgery
decrease in Wexner constipation score by 25%
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 11 Jan 2019.
- Derived from this study: PubMed 31996580Balata M, Elgendy H, Emile SH, Youssef M, Omar W, Khafagy W. Functional Outcome and Sexual-Related Quality of Life After Transperineal Versus Transvaginal Repair of Anterior Rectocele: A Randomized Clinical Trial. Dis Colon Rectum. 2020 Apr;63(4):527-537. doi: 10.1097/DCR.0000000000001595.
- Individual participant dataSharing planned: Undecided
Related trials for Rectocele
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Transanal vs Transvaginal Rectal Resection for Anterior Rectocele
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Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
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RecruitingPhase 3
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Pelvic Floor Prolapse, Functional Constipation
Enrolling by invitationObservational study
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Vaginal Vault Prolapse, Uterine Prolapse
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.
Sameh H Emile principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal repair and Transperineal repair 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 6 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 11 Jan 2019. 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?
Improvement in constipation (time frame: 6 and 12 months after surgery). 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 NCT03801291, 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 11 Jan 2019.