Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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 Names:
|
| 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 Names:
Procedure: Posterior repair
The PR surgery involves tightening the tissue between the rectum and vagina to reduce vaginal bulging during bowel movements.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Primary Outcome (obstructed defecation symptoms) [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
- Secondary Outcome (correlation between bowel symptoms scores and 3D ultrasound measurements) [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
Criteria
Inclusion Criteria:
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Female Gender
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Able to complete English language questionnaires
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Able to complete study visits for 6 months
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Bowel symptom score (PFDI-O) score ≥ 3
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Posterior vaginal bulge ≤2cm beyond the hymen
Exclusion Criteria:
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Age < 21
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Pregnancy
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History of colorectal surgery
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History of pelvic radiation
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Inflammatory bowel disease
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History of prior SCP
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
Sponsors and Collaborators
- University of Oklahoma
Investigators
- Principal Investigator: Edgar L LeClaire, MD, MS, University of Oklahoma
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
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