Anterior Rectocele, Obstructed Defaecation Syndrome
Conditions
Brief summary
This is a single-centre, prospective randomized controlled trial on female patients with anterior rectocele associated with obstructed defecation syndrome
Interventions
DRUGTransvaginal 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)
PROCEDURETransvaginal 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)
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
all required * female patients * 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
* significant urinary manifestations due to anterior vaginal wall prolapse * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate | One year |
Countries
Egypt
Outcome results
None listed