Clinical trial NCT03658395: Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms
Official title: Randomized Trial of Laparoscopic Sacrocolpopexy With Posterior Repair to Reduce Obstructed Defecation Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaginal Prolapse
Keywords: Vaginal, Prolapse, laparoscopic, sacrocolpopexy
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome (obstructed defecation symptoms)
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Secondary Outcome (correlation between bowel symptoms scores and 3D ultrasound measurements)
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Lieschen Quiroz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frick AC, Paraiso MF. Laparoscopic management of incontinence and pelvic organ prolapse. Clin Obstet Gynecol. 2009 Sep;52(3):390-400. doi: 10.1097/GRF.0b013e3181b0bf69.
citation: Elliott DS, Frank I, Dimarco DS, Chow GK. Gynecologic use of robotically assisted laparoscopy: Sacrocolpopexy for the treatment of high-grade vaginal vault prolapse. Am J Surg. 2004 Oct;188(4A Suppl):52S-56S. doi: 10.1016/j.amjsurg.2004.08.022.