Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms

University of Oklahoma (OU)

Status: Completed

Conditions: Vaginal Prolapse

Treatments: Procedure: Laparoscopic Sacrocolopopexy; Procedure: Posterior repair

Study type: Interventional

Funder types: Other

Identifiers

NCT03658395

9457 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female Gender
• Able to complete English language questionnaires
• Able to complete study visits for 6 months
• Bowel symptom score (PFDI-O) score ≥ 3
• Posterior vaginal bulge ≤2cm beyond the hymen

Exclusion criteria

• Age < 21
• Pregnancy
• History of colorectal surgery
• History of pelvic radiation
• Inflammatory bowel disease
• History of prior SCP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

LSCP Only

Active Comparator group

Description:

A Y-shaped polypropylene mesh graft, 10 cm in standard length and tailored to each patient's anatomic specifications during surgery, is used utilizing robot-assisted Laparoscopic Sacrocolopopexy.

Treatment:

Procedure: Laparoscopic Sacrocolopopexy

LSCP + PR

Active Comparator group

Description:

The Laparoscopic Sacrocolopopexy involves a Y-shaped polypropylene mesh graft, 10 cm in standard length and tailored to each patient's anatomic specifications during surgery, utilizing robot-assisted Laparoscopic Sacrocolopopexy. In addition, patients will receive posterior repair. Posterior repair is performed by midline fascial plication. Plication of superficial perineal muscles (perineorrhaphy) is performed in conjunction with posterior repair. All repairs are performed using polydioxanone 2/0 for fascial repair and 4/0 polyglactin suture for skin closure.

Treatment:

Procedure: Posterior repair

Procedure: Laparoscopic Sacrocolopopexy