RectoceleRCTNCT06633172
Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair for Anterior Rectocele.
A study testing laparoscopic ventral mesh rectopexy and Trans vaginal repair in people with Rectocele and Anterior Rectocele, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aims to compare the effect of laparoscopic ventral mesh rectopexy versus trans vaginal repair in management of anterior rectocele in females regarding functional outcomes. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Rectocele, Anterior Rectocele
- What is being tested?
- laparoscopic ventral mesh rectopexy and Trans vaginal repair
- 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 Apr 2021to 30 Apr 2023
- 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
- Female patients aged between 30 and 60 years, presented with symptomatic rectocele with failed conservative treatments.
- anterior rectocele larger than 3 cm in size with retention of the contrast in the rectocele on defecography.
- excessive straining, sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia.
Who cannot join
- significant urinary manifestations due to anterior vaginal wall prolapse.
- patients with recurrent rectocele
- complete external rectal prolapse
- isolated anismus
- connective tissue disease
- patients with slow-transit constipation
- fecal incontinence (FI), or abnormal thyroid function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair in Management of Anterior Rectocele; a Randomized Controlled Trial.
This study aims to compare the effect of laparoscopic ventral mesh rectopexy versus trans vaginal repair in management of anterior rectocele in females regarding functional outcomes.
Read the detailed description
Rectocele is the protrusion of the anterior wall of the rectum into the vaginal lumen through the rectovaginal fascia and posterior vaginal wall. Symptomatic rectocele affects postmenopausal women and causes obstructed defecation Significant rectal emptying difficulties, straining at defecation, manually assisted defecation, the need for perineal or vaginal digitation, and local symptoms such as vaginal bulging and pelvic heaviness in 30-70% of cases have been described as symptoms of rectocele .
Constipation can be managed with dietary measures, laxatives, and biofeedback training , which can be beneficial for patients with modest symptoms. Surgical treatment is recommended if conservative treatment fails to alleviate symptoms . However, some patients may be left with constipation, fecal incontinence, incomplete bowel evacuation, or sexual dysfunction despite the correction of the anatomical defect. The selection of patients for surgical intervention for symptomatic rectocele remains a matter of debate.
There is still a controversy between abdominal approaches and the transanal, transperineal, and transvaginal approaches as the optimal surgical approach to treat complex rectocele. While the latter is preferred by gynecologists, the former has increased in popularity among colorectal surgeons, aided in part by the growing interest in minimally invasive surgery.
This study aimed to evaluate the outcome of LVMR in comparison with TVR of anterior rectocele regarding the improvement in constipation score and sexual-related quality of life, surgical outcomes and postoperative complications.
- Conditions
- Rectocele, Anterior Rectocele
- Being tested
- laparoscopic ventral mesh rectopexy, Trans vaginal repair
- Keywords
- transvaginal repair, ventral mesh rectopexy, laparoscopic
- 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
Also called VMR, ventral mesh rectopexy
performing ventral mesh rectopexy via laparoscopic surgery to correct the anterior rectocele.
Trans vaginal repairProcedure or surgery
Also called TVR
performing repair of the rectocele through the recto vaginal septum repair.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic ventral mesh rectopexy | Active comparator | performing laparoscopic ventral mesh rectopexy for group of patients to find out its efficacy Receives: Procedure: laparoscopic ventral mesh rectopexy |
| Trans vaginal repair | Active comparator | performing trans vaginal repair for the 2nd group to find out its efficacy. Receives: Procedure: Trans vaginal repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of constipation
The primary outcome of the study was the absolute decline in constipation score(Cleveland clinic constipation score). This score is composed of 8 questions. Score ranges from 0 to 32. The lowest score is 0 which means no constipation, while the highest is 32 which means worsening of the constipation. So, the decline in the score means improving of the constipation.
Measured: 6 month to 1 year
Secondary outcomes (1)
improvement of sexual function
improvement in sexual function in the form of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire(PISQ- 12). PISQ-12 score is composed of 3 domains with total score of 48. It ranges from 0 to 48. The higher the score, the better the sexual outcome.
Other 2ry outcomes include: Operative time in minutes, time of wound healing in days and the postoperative complication in both groups.
Measured: 6 month to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Apr 2021
- Primary completion1 Mar 2022
- Study completion30 Apr 2023
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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Sakr, Mansoura University Hospital
- Investigators
- Ahmad Sakr, Phd, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633172
- Sponsor's protocol ID
- 11111
- Acronym
- RCT
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sanad A, Sakr A, Elfeki H, Omar W, Thabet W, Fouda E, Abdallah E, Elbaz SA. Outcomes of laparoscopic ventral mesh rectopexy versus trans-vaginal repair in management of anterior rectocele, a randomized controlled trial. Tech Coloproctol. 2025 May 27;29(1):125. doi: 10.1007/s10151-025-03145-z.
PubMed 40423835
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair in Management of Anterior Rectocele; a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06633172
- Acronym / sponsor ID
- RCT / 11111
- Conditions
- Rectocele, Anterior Rectocele
- Keywords
- transvaginal repair, ventral mesh rectopexy, laparoscopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 9 Oct 2024 (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.
This study aims to compare the effect of laparoscopic ventral mesh rectopexy versus trans vaginal repair in management of anterior rectocele in females regarding functional outcomes.
Detailed description
Rectocele is the protrusion of the anterior wall of the rectum into the vaginal lumen through the rectovaginal fascia and posterior vaginal wall. Symptomatic rectocele affects postmenopausal women and causes obstructed defecation Significant rectal emptying difficulties, straining at defecation, manually assisted defecation, the need for perineal or vaginal digitation, and local symptoms such as vaginal bulging and pelvic heaviness in 30-70% of cases have been described as symptoms of rectocele .
Constipation can be managed with dietary measures, laxatives, and biofeedback training , which can be beneficial for patients with modest symptoms. Surgical treatment is recommended if conservative treatment fails to alleviate symptoms . However, some patients may be left with constipation, fecal incontinence, incomplete bowel evacuation, or sexual dysfunction despite the correction of the anatomical defect. The selection of patients for surgical intervention for symptomatic rectocele remains a matter of debate.
There is still a controversy between abdominal approaches and the transanal, transperineal, and transvaginal approaches as the optimal surgical approach to treat complex rectocele. While the latter is preferred by gynecologists, the former has increased in popularity among colorectal surgeons, aided in part by the growing interest in minimally invasive surgery.
This study aimed to evaluate the outcome of LVMR in comparison with TVR of anterior rectocele regarding the improvement in constipation score and sexual-related quality of life, surgical outcomes and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic ventral mesh rectopexy | Active comparator | Procedure: laparoscopic ventral mesh rectopexyperforming laparoscopic ventral mesh rectopexy for group of patients to find out its efficacy |
| Trans vaginal repair | Active comparator | Procedure: Trans vaginal repairperforming trans vaginal repair for the 2nd group to find out its efficacy. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients aged between 30 and 60 years, presented with symptomatic rectocele with failed conservative treatments.
- anterior rectocele larger than 3 cm in size with retention of the contrast in the rectocele on defecography.
- excessive straining, sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia.
Key exclusion criteria (7 listed)
- significant urinary manifestations due to anterior vaginal wall prolapse.
- patients with recurrent rectocele
- complete external rectal prolapse
- isolated anismus
- connective tissue disease
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 rectopexyAlso: VMR, ventral mesh rectopexyperforming ventral mesh rectopexy via laparoscopic surgery to correct the anterior rectocele. | Procedure or surgery | laparoscopic ventral mesh rectopexy |
| Trans vaginal repairAlso: TVRperforming repair of the rectocele through the recto vaginal septum repair. | Procedure or surgery | Trans vaginal repair |
Primary outcome
Improvement of constipation
Time frame: 6 month to 1 year
The primary outcome of the study was the absolute decline in constipation score(Cleveland clinic constipation score). This score is composed of 8 questions. Score ranges from 0 to 32. The lowest score is 0 which means no constipation, while the highest is 32 which means worsening of the constipation. So, the decline in the score means improving of the constipation.
1 secondary outcome
improvement of sexual function
Time frame: 6 month to 1 year
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 9 Oct 2024.
- Derived from this study: PubMed 40423835Sanad A, Sakr A, Elfeki H, Omar W, Thabet W, Fouda E, Abdallah E, Elbaz SA. Outcomes of laparoscopic ventral mesh rectopexy versus trans-vaginal repair in management of anterior rectocele, a randomized controlled trial. Tech Coloproctol. 2025 May 27;29(1):125. doi: 10.1007/s10151-025-03145-z.
- Individual participant dataSharing planned: Undecided
Related trials for Rectocele
Not yet recruiting
Transverse Perineal Support With STARR for Anterior Rectocele With Excessive Perineal Descent
Rectocele, Perineal Descent
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.
Ahmad Sakr, Phd principal investigator
Mansoura University Hospital
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 and Trans vaginal repair in people with Rectocele and Anterior 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 3 inclusion and 7 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 9 Oct 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 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 of constipation (time frame: 6 month to 1 year). 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 NCT06633172, 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 9 Oct 2024.