Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms

NCT03658395 | Completed

• 1 other identifier: 9457
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Prolapse

Keywords

Vaginal, Prolapse, laparoscopic, sacrocolpopexy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Outcome (correlation between bowel symptoms scores and 3D ultrasound measurements)

  3 months postoperative

Study Arms (2)

LSCP Only

ACTIVE COMPARATOR

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.

Procedure: Laparoscopic Sacrocolopopexy

LSCP + PR

ACTIVE COMPARATOR

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.

Procedure: Laparoscopic Sacrocolopopexy; Procedure: Posterior repair

Interventions

Laparoscopic Sacrocolopopexy PROCEDURE

The LSCP surgery involves pulling up the bladder, vagina, and rectum using a Y-shaped mesh attached to the lower back bone

Also known as: LSCP

LSCP + PR; LSCP Only

Posterior repair PROCEDURE

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

Also known as: PR

LSCP + PR

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (2)

• 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.

  PMID: 19661755 BACKGROUND

• 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.

  PMID: 15476652 BACKGROUND

MeSH Terms

Conditions

Uterine Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lieschen Quiroz, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 5, 2018
• Study Start: July 19, 2018
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

US (1)