RectoceleNCT04502953
Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele
A study testing Vertical plication and Horizontal plication in people with Rectocele, run by Mansoura University at 1 site in Egypt.
Trial summary
We assumed that the technique of plication of the rectovaginal septum and rectal wall may factor in providing better and more sustained repair that confers more satisfactory improvement in symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectocele
- What is being tested?
- Vertical plication and Horizontal plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 30 May 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vertical plication of the rectovaginal septum was done
Who cannot join
- patients with ODS caused by conditions other than rectocele such as anismus and internal rectal prolapse
- patients with slow transit constipation.
- patients with recurrent rectocele after previous surgery.
- patients with pre-existing FI
- patients with associated anorectal pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele; a Randomized Controlled Trial
We assumed that the technique of plication of the rectovaginal septum and rectal wall may factor in providing better and more sustained repair that confers more satisfactory improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR with vertical plication of the rectovaginal septum as compared to the horizontal plication with regards to improvement in ODS, recurrence of rectocele, postoperative complications and dyspareunia.
- Conditions
- Rectocele
- Being tested
- Vertical plication, Horizontal plication
- Medical subject headings
- Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertical plicationProcedure or surgery
Vertical plication of the rectovaginal septum was done
Horizontal plicationProcedure or surgery
Horizontal plication of the rectovaginal septum was done
| Study group | Role | What they receive |
|---|---|---|
| Vertical plication | Active comparator | Vertical plication of the rectovaginal septum was done Receives: Procedure: Vertical plication |
| Horizontal plication | Active comparator | Horizontal plication of the rectovaginal septum was done Receives: Procedure: Horizontal plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete cure of symptoms
Absence of symptoms of constipation with Wexner score <2
Measured: 12 months after repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Jun 2018
- Primary completion30 Apr 2019
- Study completion30 May 2020
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, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sameh H Emile, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502953
- Sponsor's protocol ID
- Mansoura20201
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Vertical Versus Horizontal Plicataion in Transperienal Repair of Rectocele; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04502953
- Acronym / sponsor ID
- Mansoura20201
- Conditions
- Rectocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 6 Aug 2020 (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.
We assumed that the technique of plication of the rectovaginal septum and rectal wall may factor in providing better and more sustained repair that confers more satisfactory improvement in symptoms. The present randomized study aimed to evaluate the outcome of TPR with vertical plication of the rectovaginal septum as compared to the horizontal plication with regards to improvement in ODS, recurrence of rectocele, postoperative complications and dyspareunia.
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 |
|---|---|---|
| Vertical plication | Active comparator | Procedure: Vertical plicationVertical plication of the rectovaginal septum was done |
| Horizontal plication | Active comparator | Procedure: Horizontal plicationHorizontal plication of the rectovaginal septum was done |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Vertical plication of the rectovaginal septum was done
Key exclusion criteria (5 listed)
- patients with ODS caused by conditions other than rectocele such as anismus and internal rectal prolapse
- patients with slow transit constipation.
- patients with recurrent rectocele after previous surgery.
- patients with pre-existing FI
- patients with associated anorectal pathology.
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 |
|---|---|---|
| Vertical plicationVertical plication of the rectovaginal septum was done | Procedure or surgery | Vertical plication |
| Horizontal plicationHorizontal plication of the rectovaginal septum was done | Procedure or surgery | Horizontal plication |
Primary outcome
Complete cure of symptoms
Time frame: 12 months after repair
Absence of symptoms of constipation with Wexner score <2
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 6 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Sameh H Emile study chair
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 Vertical plication and Horizontal plication 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 5 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 6 Aug 2020. 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?
Complete cure of symptoms (time frame: 12 months after repair). 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 6 Aug 2020.