Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial
NCT ID: NCT06804993
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2021-07-31
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Transvaginal repair & botulinum toxin type A toxin injection
Transvaginal repair & botulinum toxin type A injection
100 units of lyophilized botulinum toxin type A were diluted in saline to 50 U/mL before the injections. A total of 30 units of type-A botulinum toxin was injected with a 22-G needle evenly divided in 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)
Transvaginal repair & distilled water injection
Transvaginal repair & distilled water injection
A total of 30 units of distilled water was injected with a 22-G needle evenly divided into 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)
Interventions
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Transvaginal repair & botulinum toxin type A injection
100 units of lyophilized botulinum toxin type A were diluted in saline to 50 U/mL before the injections. A total of 30 units of type-A botulinum toxin was injected with a 22-G needle evenly divided in 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)
Transvaginal repair & distilled water injection
A total of 30 units of distilled water was injected with a 22-G needle evenly divided into 3 sites, 2 on either side of the internal anal sphincter (3 and 9 O'clock) and the third anteriorly (at 12 O'clock)
Eligibility Criteria
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Inclusion Criteria
* symptomatic rectocele
* failed conservative treatments for at least 3 months
* anterior rectocele larger than 3 cm in size in defecogram.
* retention of the contrast in the rectocele on defecography
* obstructed defecation manifestations: excessive straining, a sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia
Exclusion Criteria
* recurrent rectocele
* previous anal surgery
* slow-transit constipation
* faecal incontinence (FI)
* abnormal thyroid functions
* patients under systemic steroid treatment
* patients with connective tissue disease
* ASA classification \>3
18 Years
65 Years
FEMALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Mostafa shalaby, MD, MSc, PhD
Associate Professor & Consultant Colorectal Surgeon
Locations
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Mansoura University Hospital
Al Mansurah, , Egypt
Countries
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Other Identifiers
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MD.21.03.441
Identifier Type: -
Identifier Source: org_study_id
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