Transanal vs Transvaginal Rectal Resection for Anterior Rectocele

Browse trials for

• Rectocele 50

Keywords

• Rectocele
• Obstructed defecation
• Stapled Transanal Rectal Resection
• Stapled Transvaginal Rectal Resection

Rectocele

50 studies on the registry are indexed under Rectocele; 9 are open to participants now.

This study's planned enrollment of 62 is close to the median of 62 across 37 interventional studies indexed under Rectocele.

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Study arms

• Active comparator
  Stapled Transanal Rectal Resection

  Patients in this group will be conducted to Stapled Transanal rectal resection for the anterior rectocele

  Procedure: Stapled Transanal Rectal Resection

• Experimental
  Stapled Transvaginal Rectal Resection

  patients in this group will be conducted to stapled transvaginal rectal resection for the anterior rectocele

  Procedure: Stapled Transvaginal Rectal Resection

Interventions

• ProcedureStapled Transanal Rectal Resection

  Patients were placed in the lithotomy position. Using the trans-anal approach, rectocele was done using PPH circular staplers. A circular anal dilator (CAD) was inserted into the anus and sutured into position. Three full-thickness prolene 2/0 sutures were positioned at the anterior, left anterior lateral, and right anterior lateral locations, approximately 4 cm above the dentate line. At the posterior aspect, a tongue depressor was placed into the CAD groove to protect the posterior rectal wall. After insertion of the Procedure for Prolapse and Hemorrhoids stapler (PPH stapler) into the rectum with its head open past the proximal suture, PPH stapler was progressively closed. Per vaginal examination was done To make sure the stapler did not include the vagina. The stapler was then fired to complete the anterior rectal resection.

• ProcedureStapled Transvaginal Rectal Resection

  The patient in the lithotomy position. Anal dilatation was performed. A transverse incision was made in the mucocutaneous border of the vaginal introitus; the posterior vaginal wall was dissected and separated from the anterior rectal wall up to the posterior fornix. Dissection was extended laterally to the maximum length of the rectocele. Two Babcock clamps were applied longitudinally to the rectocele, and the stapler was fired to divide the rectocele. Partial thickness stitches were applied over the staple line using vicryl 2/0 suture to reinforce the staple line.

Primary outcomes

1. Improvement in obstructed defecation symptoms in both groups using Cleveland Clinic Constipation (CCC) score

   Compare Improvement in obstructed defecation symptoms in both groups using Cleveland Clinic Constipation (CCC) score. CCC score ranges from 0 to 30. 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. Hospitalization period

   Compare how many days patients stay in hospital in both groups

   Time frame: From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery

3. surgical site infection

   compare surgical site infection in both groups

   Time frame: Up to 6 months postoperatively

4. Time for wound Healing

   Time for wound Healing in both groups

   Time frame: Up to 6 months postoperatively

5. Postoperative bleeding

   Compare Postoperative bleeding in both groups

   Time frame: Up to 6 months postoperatively

6. Postoperative fecal incontinence

   Compare post postoperative fecal incontinence in both groups

   Time frame: Up to 6 months postoperatively

7. Postoperative urine retention

   Compare postoperative urine retention in both groups

   Time frame: Within 48 hours postoperatively

8. 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: At day 1 and day 7 postoperatively

9. Sexual Function in both groups

   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

   Time frame: Up to 6 months postoperatively

10. Postoperative anal stenosis in both groups

    Postoperative anal stenosis will be assessed by digital rectal examination and graded clinically as follows: * Mild: anal canal admits a well lubricated index finger. * Moderate: Forceful dilatation required to admit a well lubricated index finger. * Severe: Little finger cannot be admitted without forceful dilatation

    Time frame: Up to 6 months postoperatively

11. Postoperative rectovaginal fistula in both groups

    Postoperative rectovaginal fistula will be assessed using the following methods: * History: Passage of flatus or stool from the vagina. * Clinical examination: Digital rectal examination and per vaginal examination to detect induration or fistula opening. * MRI of the pelvis: Performed if fistula is suspected based on history or clinical examination to confirm the diagnosis.

    Time frame: Up to 6 months postoperatively

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared because this is a small surgical trial with a limited number of participants, and sharing raw data could lead to identification of participants