N/A
Completed N=59
Randomized Trial of Y Mesh vs Dual Mesh
Prolapse
Source: ClinicalTrials.gov NCT02156687 ↗
Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Total Suturing Time for Mesh Placement = Time From Insertion of Y Mesh or First Flat Mesh Arm Into Pelvis to Last Sacral Suture Placed — 46; 46.3 minutes
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Suturing Time for Mesh Placement = Time From Insertion of Y Mesh or First Flat Mesh Arm Into Pelvis to Last Sacral Suture Placed |
46; 46.3 | — |
| PRIMARY Total OR Time = Operating Room Time of Entry and Exit |
204.2; 204.5 | — |
| SECONDARY Post-operative Mean Difference POPDI at 24 Months |
-32.5; -40.7 | — |
| SECONDARY Postoperative Mean Difference CRADI at 24 Months |
-24.2; -20.2 | — |
| SECONDARY Postoperative Mean Difference UDI at 24 Months |
-39.0; -33.2 | — |
| SECONDARY Postoperative Subjective Recurrence at 24 Months |
2; 2 | — |
| SECONDARY Postoperative Objective Recurrence at 24 Months |
5; 4 | — |
| SECONDARY Reported Mesh Erosion at 24 Months |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02156687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.