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Completed

NCT Number: NCT03658395

Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms

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.

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Key information

Conditions

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

Age range

21 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: LSCP

Posterior repair

Procedure

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

Other names: PR

Primary outcomes

  1. Primary Outcome (obstructed defecation symptoms)

    Time frame: 3 months postoperative

    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.

Secondary outcomes

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

    Time frame: 3 months postoperative

    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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2018
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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