Randomized Trial of Y Mesh vs Dual Mesh

Completed · Not applicable

Conditions studied: Prolapse

In brief

The primary objective of the proposed study is to determine the difference in suturing time when using the restorelle Y mesh versus the restorelle dual flat mesh at the time of laparoscopic and robotic-assisted laparoscopic sacrocolpopexy. Hypothesis: Suturing time when using the restorelle Y mesh will be faster than when using the restorelle dual flat mesh at the time of laparoscopic and robotic-assisted laparoscopic sacrocolpopexy.

Key facts

Study ID

NCT02156687

Run by

The Cleveland Clinic

People needed

59

Starts

2014-04-14

Expected to finish

2020-04-01

Last updated by the study team

2020-11-24

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18, who are to undergo laparoscopic or robotic laparoscopic sacrocolpopexy for pelvic organ prolapse
• Other concomitant laparoscopic or prolapse and anti-incontinence procedures (e.g., laparoscopic supracervical hysterectomy, cystocele repair, rectocele repair or mid-urethral sling procedures) will be performed at the primary surgeon's discretion.

You may not qualify if…

• Inability to comprehend written and/or spoken English
• Inability to provide informed consent
• Medical illness precluding laparoscopy
• Need for concomitant surgeries not related to pelvic organ prolapse or incontinence
• Sacrocolpoperineopexy

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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