Perineal Descent, Rectocele
Conditions
Keywords
rectocele, Perineal Descent, Transverse Perineal Support
Brief summary
This prospective randomized controlled trial will include adult patients with ODS, anterior rectocele ≥3 cm, and excessive perineal descent following failure of conservative treatment. Patients will be randomized 1:1 to STARR alone or STARR combined with transverse perineal support procedure using polypropylene mesh. The primary outcome will be Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups. Secondary outcomes will include operative time, postoperative pain, surgical complications, surgical site infection, and sexual function assessed using the PISQ-12. Patients will be followed up twice during the first postoperative week, weekly during the first month, and monthly thereafter.
Detailed description
This will be a prospective, randomized controlled trial conducted at Kasr Al-Ainy Hospitals, Cairo University, including adult patients of either sex with obstructed defecation syndrome (ODS) associated with rectocele, and excessive perineal descent. Eligible patients must have anterior rectocele ≥3 cm, excessive perineal descent, and failure of conservative treatment. Patients with Slow-transit constipation, anterior rectocele of \< 3 cm, complete external rectal prolapse, evidence of colorectal carcinoma or Inflammatory bowel disease ( IBD), Patients with fecal incontinence, Inability for lifestyle change postoperatively, or previous surgeries for anterior rectocele will be excluded. Following informed written consent, Eligible participants will be randomized in a 1:1 ratio using computer-generated randomization, with allocation concealment through sequentially numbered, opaque, sealed envelopes. Patients will be allocated to either Group A (STARR alone) or Group B (STARR combined with transverse perineal support using non-absorbable polypropylene mesh). Postoperative assessment will include operative time, pain using the visual analogue scale, and postoperative complications. Patients will be followed-up twice weekly in the first postoperative week, weekly during the first month, and monthly thereafter. The primary outcome will be Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups. Secondary outcomes will include operative time, postoperative pain, surgical site infection, sexual function assessed by Pelvic Organ Prolapse/Urinary incontinence sexual questionnaire (PISQ-12), and postoperative complications.
Interventions
PROCEDURESTARR Procedure
The STARR procedure will be performed using PPH circular stapler to achieve trans-anal full-thickness resection of the rectocele
PROCEDURESTARR combined with transverse perineal support procedure
Transverse perineal support procedure will be added to STARR procedure. it will be done using a non-absorbable polypropylene mesh to reinforce the perineal body and correct excessive perineal descent.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients complaining of obstructed defecation syndrome with anterior rectocele ≥ 3 cm associated with excessive perineal descent with failure of conservative management.
Exclusion criteria
* Patients with Slow-transit constipation * Patients with anterior rectocele of \< 3 cm * Patients with complete external rectal prolapse * Evidence of colorectal carcinoma or Inflammatory bowel disease ( IBD) * Inability for lifestyle change postoperatively * Patients with fecal incontinence * Previous surgeries for anterior rectocele
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups. | Up to 6 months postoperatively | Compare Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups. Obstructed Defecation Syndrome score (ODS-S; Renzi score) ranges from 0 to 20. Higher scores indicate a worse outcome (more severe obstructed defecation symptoms ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | During surgery | Compare time of operation between both procedure |
| Number of participants with surgical site infection | Up to 6 months postoperatively | compare surgical site infection in both groups (surgical site infection: infection at or near a surgical incision within 30 days post-surgery, marked by redness, swelling, or pus.) |
| Postoperative urine retention | Within 48 hours postoperatively | Compare incidence of postoperative urine retention in both groups. (Postoperative urinary retention: inability to void spontaneously after surgery with a bladder volume ≥500 mL on bladder ultrasound). |
| Pain intensity | Up to 6 months postoperatively | Compare Pain intensity measured using Visual Analogue Scale between both groups (Visual Analogue Scale for Pain: ranges from 0 to 10 . Higher scores indicate a worse outcome {greater pain intensity}) |
| Sexual Function in both groups | Up to 6 months postoperatively | Compare sexual function in both groups using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ- 12). PISQ-12 score ranges from 0 to 48. Higher scores indicate better sexual function |
| Hospitalization period | From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery | Compare how many days patients stay in hospital in both groups |
Countries
Egypt
Contacts
CONTACTAhmed Mohamed Abdelaal, Lecturer
STUDY_DIRECTORHaitham M.Azmy Basiouny, MD
Cairo University
Outcome results
None listed