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Insufflation during surgery for Pelvic Organ Prolapse

N/A
Waitlist Available
Research Sponsored by Ascension South East Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pain will be assessed at the two-week post-operative follow-up visit.
Awards & highlights

Study Summary

This trial looks at different ways to manage pain during and after surgery for a condition called sacrocolpopexy, which is a fix for a prolapsed (fallen) uterus.

Eligible Conditions
  • Pelvic Organ Prolapse

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~safety will be assessed at the two-week follow-up visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and safety will be assessed at the two-week follow-up visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-operative Pain on a visual analogue scale, ranging from 1-10 with a higher score meaning more pain.
Safety using Operation length, blood loss, need to increase insufflation, operative conversion rates. These are all counts with higher numbers meaning worse outcomes.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Low Insufflation GroupExperimental Treatment1 Intervention
Patients will receive a lower level of insufflation during surgery (12 mm Hg or lower).
Group II: Standard Insufflation GroupActive Control1 Intervention
Patients will receive standard insufflation during surgery (15 mm Hg).

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Who is running the clinical trial?

Ascension South East MichiganLead Sponsor
18 Previous Clinical Trials
32,444 Total Patients Enrolled
~19 spots leftby Jun 2025
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