Randomized Trial of Y Mesh vs Dual Mesh

NCT02156687 | Completed Results

• 1 other identifier: 14-354
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prolapse

Outcome Measures

Primary Outcomes (2)

• Total Suturing Time for Mesh Placement = Time From Insertion of Y Mesh or First Flat Mesh Arm Into Pelvis to Last Sacral Suture Placed

  one day intraoperative

• Total OR Time = Operating Room Time of Entry and Exit

  one day intraoperative

Secondary Outcomes (6)

• Post-operative Mean Difference POPDI at 24 Months

  24 months

• Postoperative Mean Difference CRADI at 24 Months

  24 months

• Postoperative Mean Difference UDI at 24 Months

  24 months

• Postoperative Subjective Recurrence at 24 Months

  24 months

• Postoperative Objective Recurrence at 24 Months

  24 months

Study Arms (2)

Cololast, Inc. Restorell Y mesh

ACTIVE COMPARATOR

Y mesh

Device: Y mesh

Coloplast, Inc. Restorelle Dual flat mesh

ACTIVE COMPARATOR

Dual flat mesh

Device: Dual flat mesh

Interventions

Y mesh DEVICE

Y mesh

Also known as: Cololast, Inc. Restorell Y mesh

Cololast, Inc. Restorell Y mesh

Dual flat mesh DEVICE

Dual flat mesh

Also known as: Coloplast, Inc. Restorelle Dual flat mesh

Coloplast, Inc. Restorelle Dual flat mesh

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The biggest limitation in this study was lost to follow-up; however, this limitation was mitigated apriori by considering potential lost to follow-up in our power analysis.

Results Point of Contact

• Title: Cecile Ferrando, M.D.
• Organization: Cleveland Clinic

ferranc2@ccf.org

216-444-0642

Study Officials

• Cecile Unger, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 5, 2014
• Study Start: April 14, 2014
• Primary Completion: November 7, 2019
• Study Completion: April 1, 2020
• Last Updated: November 24, 2020
• Results First Posted: October 29, 2020

Record last verified: 2020-11

Locations

US (1)