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Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03658395
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Vaginal Prolapse Procedure: Laparoscopic Sacrocolopopexy Procedure: Posterior repair Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Trial of Laparoscopic Sacrocolpopexy With Posterior Repair to Reduce Obstructed Defecation Symptoms
Actual Study Start Date : July 19, 2018
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LSCP Only
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
The LSCP surgery involves pulling up the bladder, vagina, and rectum using a Y-shaped mesh attached to the lower back bone
Other Name: LSCP
Active Comparator: LSCP + PR

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

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658395


Contacts
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Contact: Valori Kruse, BA 405-271-8001 Valori-Kruse@ouhsc.edu
Contact: Christy Zornes, MPH 405-271-8001 ext 48137 Christy-Zornes@ouhsc.edu

Locations
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United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Valori Kruse    405-271-8001    Valori-Kruse@ouhsc.edu   
Contact: Christy Zornes, MPH    405-271-8001 ext 48137    Christy-Zornes@ouhsc.edu   
Principal Investigator: Edgar L. LeClaire, MD, MS         
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Edgar L LeClaire, MD, MS University of Oklahoma
More Information
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Publications:

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03658395    
Other Study ID Numbers: COMAA_Sacrocolpopexy
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oklahoma:
Vaginal, Prolapse, laparoscopic, sacrocolpopexy
Additional relevant MeSH terms:
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Uterine Prolapse
Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Pelvic Organ Prolapse