Vaginal Prolapse
Conditions
Keywords
Vaginal, Prolapse, laparoscopic, sacrocolpopexy
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.
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.
Interventions
PROCEDURELaparoscopic Sacrocolopopexy
The LSCP surgery involves pulling up the bladder, vagina, and rectum using a Y-shaped mesh attached to the lower back bone
PROCEDUREPosterior repair
The PR surgery involves tightening the tissue between the rectum and vagina to reduce vaginal bulging during bowel movements.
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed