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Transverse Perineal Support With STARR for Anterior Rectocele With Excessive Perineal Descent

ConditionsRectocelePerineal Descent
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients complaining of obstructed defecation syndrome with anterior rectocele ≥ 3 cm associated with excessive perineal descent with failure of conservative management.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • STARR Procedure

    Procedure/Surgery

    The STARR procedure will be performed using PPH circular stapler to achieve trans-anal full-thickness resection of the rectocele

  • STARR combined with transverse perineal support procedure

    Procedure/Surgery

    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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: STARR procedureActive comparator 1 intervention
Group B: STARR combined with transverse perineal support procedureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups.

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 )

Time frame
Up to 6 months postoperatively

Secondary outcomes

1

Operative time

Compare time of operation between both procedure

Time frame
During surgery
2

Number of participants with surgical site infection

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.)

Time frame
Up to 6 months postoperatively
3

Postoperative urine retention

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).

Time frame
Within 48 hours postoperatively
4

Pain intensity

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})

Time frame
Up to 6 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: