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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
Scheduled to have a robotic-assisted sacrocolpopexy surgery for pelvic organ prolapse.
Age 18-90 years
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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).

Find a Location

Who is running the clinical trial?

Ascension South East MichiganLead Sponsor
18 Previous Clinical Trials
33,110 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being enrolled for this experiment?

"The details hosted by clinicaltrials.gov suggest that this medical study is recruiting participants, with initiation of the trial taking place on April 2nd 2021 and a subsequent update to the listing made on April 23rd 2021."

Answered by AI

What is the aggregate number of individuals participating in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical experiment opened for recruitment on April 2nd 2021 and underwent its last update a 21 days later. 80 individuals need to be recruited from just 1 location."

Answered by AI

Am I eligible to join this clinical research initiative?

"This medical experiment is currently seeking 80 individuals with pelvic organ prolapse, aged between 18 and 90 years old. To be eligible for the trial these requirements should be met: comprehending and consenting to the procedure in writing, a scheduled robotic-assisted sacrocolpopexy surgery for their condition, being within the requisite age range."

Answered by AI

Are individuals who are 35 years or older being considered for enrollment in this trial?

"The target demographic for this medical trial is individuals aged 18 to 90."

Answered by AI
~20 spots leftby Mar 2025