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Anchor for Robotic Sacrocolpopexy

NCT03378622 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2019-03-06

No results posted yet for this study

Summary

1. PRIMARY OBJECTIVE: To assess the effect of absorbable anchor compared to suturing for mesh attachment to vagina in robotic assisted sacrocolpopexy on the length of surgery for this portion of the procedure.
2. SECONDARY OBJECTIVES:

i. To assess intraoperative and ii. postoperative complication rates, iii. Intraoperative 10 cm visual analog scale (VAS), to subjectively assess surgeon satisfaction with the technique iv. post-operative Pelvic Organ Prolapse Quantification (POPQ) evaluation for anatomic failure and v. a VAS of the vaginal walls overall appearance

Conditions

  • Pelvic Organ Prolapse

Interventions

OTHER

Anchor

Anchor technique for mesh attachment

OTHER

Suture

Suture technique for mesh attachment

Sponsors & Collaborators

Principal Investigators

  • Alexander A Berger · Kaiser Permanente

  • Shawn A Menefee, MD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2020-01-01
Completion
2020-01-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03378622 on ClinicalTrials.gov