NCT03658395

Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms

Randomized Trial of Laparoscopic Sacrocolpopexy With Posterior Repair to Reduce Obstructed Defecation Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Participants who undergo laparoscopic sacrocolpopexy (LSCP) plus posterior repair (PR) will demonstrate greater improvement bowel symptom scores compared to participants who undergo LSCP alone at 3 months postoperatively.

Detailed description

Those who provide informed consent will be randomized into either laparoscopic sacrocolpopexy (LSCP) alone or laparoscopic sacrocolpopexy (LSCP) plus posterior repair (PR). Participants will be randomized with equal probability to the LSCP only arm or LSCP plus PR arm. The surgical technique for LSCP will be similar to that described by Paraiso et al. for LSCP \[14\] and by Elliott et al. for robot-assisted LSCP \[15\], with minor variations. A Y-shaped polypropylene mesh graft, 10 cm in standard length and tailored to each patient's anatomic specifications during surgery, will be used with all SCP procedures. PR is performed by midline fascial plication. Plication of superficial perineal muscles (perineorrhaphy) is performed in conjunction with PR. All repairs are performed using polydioxanone 2/0 for fascial repair and 4/0 polyglactin suture for skin closure. Participants will also complete questionnaires and undergo an endovaginal ultrasound (using a 9-16 MHz, 360° rotational transducer, type 8838, BK Medical, Peabody, MA) prior to surgery and three months following surgery.

Conditions

• Vaginal Prolapse

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic Sacrocolopopexy	The LSCP surgery involves pulling up the bladder, vagina, and rectum using a Y-shaped mesh attached to the lower back bone
PROCEDURE	Posterior repair	The PR surgery involves tightening the tissue between the rectum and vagina to reduce vaginal bulging during bowel movements.

Timeline

• Start date: 2018-07-19
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2018-09-05
• Last updated: 2024-12-06

Locations

1 site across 1 country: United States