Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms

Vaginal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03658395
• Other study ID #: 9457
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 19, 2018
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Uterine Prolapse
• Vaginal Prolapse

Intervention

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
• Posterior repair
The PR surgery involves tightening the tissue between the rectum and vagina to reduce vaginal bulging during bowel movements.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome (obstructed defecation symptoms)	The primary outcome of this study (AIM 1) is to compare bowel symptom scores in patients with ODS who undergo LSCP+PR compared to those who undergo LSCP only. Our primary outcome is a composite score from Questions 4, 7, and 8 of the PFDI-20.The responses to these three questions will be summed to a maximum score of 12. The ODS questionnaire is a validated, disease-specific, scoring system commonly used in the colorectal literature, which measures constipation severity, specifically outlet obstruction. Validated pelvic floor symptom survey data using the Pelvic Floor Distress Inventory-20 (PFDI-20), Pelvic Floor Impact Questionaire-7 (PFIQ-7), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12) will be obtained at study time points.	3 months postoperative
Secondary	Secondary Outcome (correlation between bowel symptoms scores and 3D ultrasound measurements)	For our secondary outcome, (AIM2) we will establish a correlation between bowel symptoms score and 3D ultrasound measurements of rectal support and LAM defects. Sonographic data will consist of Levator Ani Deficiency (LAD) score and Levator Plate Descent (LPDA) angle. Bowel symptom scores will be a subscale of the PFDI calculated using questions 4, 7, and 8 referring to splinting, straining, and incomplete emptying, respectively. The responses to these three questions will be summed to a maximum score of 12. We refer to these three questions collectively as the PFDI-Obstructed (PFDI-O), to represent obstructed defecation.	3 months postoperative