RectoceleNCT05894226
Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele
A study testing laparoscopic ventral mesh rectopexy in people with Rectocele and Obstructive Defecation Syndrome, run by Mansoura University at 1 site in Egypt.
Trial summary
The ideal surgical strategy for treating complex rectocele remains a topic for debate, with the transanal, transperineal, and transvaginal approach and the abdominal approach being at conflict with one another. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Rectocele, Obstructive Defecation Syndrome
- What is being tested?
- laparoscopic ventral mesh rectopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 30 Aug 2022
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- multiparous female patients.
- aged between 30 and 60 years
- who were diagnosed with complex anterior rectocele- more than 3cm after failed medical treatment- with history of either vaginal delivery or caesarian section.
- complex rectocele was one having any of the following features: size > 3 cm in diameter, associated enterocoele or internal rectal prolapse
Who cannot join
- paradoxical contraction of puborectalis muscle (anismus),
- complete external rectal prolapse
- fecal incontinence
- other benign anal conditions
- those who are unfit for surgery due to associated severe co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
The ideal surgical strategy for treating complex rectocele remains a topic for debate, with the transanal, transperineal, and transvaginal approach and the abdominal approach being at conflict with one another. While the transvaginal repair is more popular among gynecologists, the trans abdominal approach has become increasingly common among colorectal surgeons, in part due to the rising demand for minimally invasive surgery.
Read the detailed description
For the treatment of rectoceles and ODS in general, the laparoscopic method has recently come to light as a promising alternative.
Laparoscopic ventral mesh rectopexy (LVMR) was originally described for the management of rectal prolapse. However, It was also recommended with encouraging results for the treatment of large symptomatic rectocele.
The present study aims to evaluate the safety and efficacy of LVMR for complex rectocele.
- Conditions
- Rectocele, Obstructive Defecation Syndrome
- Being tested
- laparoscopic ventral mesh rectopexy
- Keywords
- Anterior rectocele, laparoscopic ventral mesh rectopexy
- Medical subject headings
- Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic ventral mesh rectopexyProcedure or surgery
patients are treated by laparoscopic ventral mesh rectopexy for anterior rectocele
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic ventral mesh rectopexy arm | Experimental | those who were underwent laparoscopic ventral mesh rectopexy for rectocele. Receives: Procedure: laparoscopic ventral mesh rectopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the Wexner constipation score
improvement in constipation, if the score is decreasing this means improving
Measured: 6 months
Secondary outcomes (1)
sexual function changes
changes in the sexual function score post operative (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score(PISQ-12). The lower the score the better the function.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Mar 2021
- Primary completion1 Feb 2022
- Study completion30 Aug 2022
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Sakr, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894226
- Sponsor's protocol ID
- 2233
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 8 Jun 2023
- 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 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele
- ClinicalTrials.gov ID
- NCT05894226
- Acronym / sponsor ID
- 2233
- Conditions
- Rectocele, Obstructive Defecation Syndrome
- Keywords
- Anterior rectocele, laparoscopic ventral mesh rectopexy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 8 Jun 2023 (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.
The ideal surgical strategy for treating complex rectocele remains a topic for debate, with the transanal, transperineal, and transvaginal approach and the abdominal approach being at conflict with one another. While the transvaginal repair is more popular among gynecologists, the trans abdominal approach has become increasingly common among colorectal surgeons, in part due to the rising demand for minimally invasive surgery.
Detailed description
For the treatment of rectoceles and ODS in general, the laparoscopic method has recently come to light as a promising alternative.
Laparoscopic ventral mesh rectopexy (LVMR) was originally described for the management of rectal prolapse. However, It was also recommended with encouraging results for the treatment of large symptomatic rectocele.
The present study aims to evaluate the safety and efficacy of LVMR for complex rectocele.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laparoscopic ventral mesh rectopexy arm | Experimental | Procedure: laparoscopic ventral mesh rectopexythose who were underwent laparoscopic ventral mesh rectopexy for rectocele. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- multiparous female patients.
- aged between 30 and 60 years
- who were diagnosed with complex anterior rectocele- more than 3cm after failed medical treatment- with history of either vaginal delivery or caesarian section.
- complex rectocele was one having any of the following features: size > 3 cm in diameter, associated enterocoele or internal rectal prolapse
Key exclusion criteria (5 listed)
- paradoxical contraction of puborectalis muscle (anismus),
- complete external rectal prolapse
- fecal incontinence
- other benign anal conditions
- those who are unfit for surgery due to associated severe co-morbidities
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 |
|---|---|---|
| laparoscopic ventral mesh rectopexypatients are treated by laparoscopic ventral mesh rectopexy for anterior rectocele | Procedure or surgery | laparoscopic ventral mesh rectopexy arm |
Primary outcome
changes in the Wexner constipation score
Time frame: 6 months
improvement in constipation, if the score is decreasing this means improving
1 secondary outcome
sexual function changes
Time frame: 6 months
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 8 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Rectocele
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Recruiting
Transanal vs Transvaginal Rectal Resection for Anterior Rectocele
Rectocele; Female
Recruiting
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
Colorectal Disorders, Prolapse
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic ventral mesh rectopexy in people with Rectocele and Obstructive Defecation Syndrome, 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 4 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 8 Jun 2023. 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?
changes in the Wexner constipation score (time frame: 6 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 8 Jun 2023.