Sacrocolpopexy With Posterior Repair Obstructed Defecation Symptoms
Status: | Recruiting |
---|---|
Conditions: | Women's Studies |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 21 - 80 |
Updated: | 11/16/2018 |
Start Date: | July 19, 2018 |
End Date: | July 19, 2019 |
Contact: | Trynisha Cheadle, RN |
Email: | Trynisha-Cheadle@ouhsc.edu |
Phone: | 405-271-8001 |
Randomized Trial of Laparoscopic Sacrocolpopexy With Posterior Repair to Reduce 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.
demonstrate greater improvement bowel symptom scores compared to participants who undergo
LSCP alone at 3 months postoperatively.
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.
(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.
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
We found this trial at
1
site
940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Edgar L. LeClaire, MD, MS
Phone: 405-271-8001
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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