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Procedure

Sterilization Procedures for Women's Health (POPS Trial)

N/A
Recruiting
Led By Randa J Jalloul, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing 3 different ways to do a laparoscopic salpingectomy to see which is best for the patient in terms of experience, recovery, and satisfaction.

Who is the study for?
The POPS Trial is for premenopausal women who are planning to have elective sterilization surgery and can give written consent. Women with a non-prolapsed uterus are eligible, but those with conditions like rectal surgery history, suspected endometriosis or malignancy, infections, virginity or pregnancy cannot participate.
What is being tested?
This study compares patient experiences after laparoscopic salpingectomy (tube removal for sterilization) done through three different surgical methods: traditional laparoscopy, single-site laparoscopy, and V-Notes surgery. It aims to assess recovery quality, preferences and satisfaction.
What are the potential side effects?
While the trial's description does not specify side effects, typical risks of these surgeries may include pain at the incision site, bleeding, infection risk post-surgery and potential complications related to anesthesia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire
Secondary study objectives
Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI)
Cosmesis as assessed by the Body Image Questionnaire
Pain as assessed by the Dynamic Visual Analog Scale (VAS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Route C:V-Notes surgery"Experimental Treatment1 Intervention
Group II: Route B: Single site laparoscopyExperimental Treatment1 Intervention
Group III: Route A: Traditional laparoscopyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,707 Total Patients Enrolled
Randa J Jalloul, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
76 Total Patients Enrolled

Media Library

Single site laparoscopy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05518175 — N/A
Female Infertility Research Study Groups: Route A: Traditional laparoscopy, Route B: Single site laparoscopy, Route C:V-Notes surgery"
Female Infertility Clinical Trial 2023: Single site laparoscopy Highlights & Side Effects. Trial Name: NCT05518175 — N/A
Single site laparoscopy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05518175 — N/A
~49 spots leftby Dec 2025
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