Sterilization Procedures for Women's Health

(POPS Trial)

Overseen By Sunbola S Ashimi Ademola

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Rectal surgery, Endometriosis, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Randa J Jalloul, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Route C:V-Notes surgery" Experimental Treatment 1 Intervention

Group II: Route B: Single site laparoscopy Experimental Treatment 1 Intervention

Group III: Route A: Traditional laparoscopy Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+