150 Participants Needed

Sterilization Procedures for Women's Health

(POPS Trial)

RJ
SS
Overseen BySunbola S Ashimi Ademola
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes.

Research Team

RJ

Randa J Jalloul, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Inclusion Criteria

Patients should be able to provide written consent
I am a premenopausal woman planning to have sterilization surgery.
My uterus is in its normal position.

Exclusion Criteria

I had my tubes tied right after giving birth.
I had my tubes tied during a C-section.
I cannot have vaginal procedures due to my medical history or current conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo laparoscopic salpingectomy via one of three surgical routes

1 day
1 visit (in-person)

Immediate Recovery

Quality of recovery assessed 24 hours after surgery using the QOR-40 questionnaire

1 day

Follow-up

Participants are monitored for outcomes such as cosmesis, pain, patient satisfaction, and sexual function

3 months

Treatment Details

Interventions

  • Single site laparoscopy
  • Traditional laparoscopy
  • V-Notes surgery
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+
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