Patient-centered Outcomes After Permanent Female Sterilization Procedure(POPS Trial) (POPS)

January 22, 2026 updated by: Randa Jalloul, The University of Texas Health Science Center, Houston

Patient-centered Outcomes After Permanent Female Sterilization Procedure: A Randomized Controlled Trial Comparing Three Surgical Routes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

255

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Premenopausal women scheduled to undergo an elective sterilization surgery regardless of parity
  • non-prolapsed uterus
  • Patients should able to provide written consent

Exclusion Criteria:

  • Women who have relative contra-indication to vaginal peritoneal access such as: history of rectal surgery, suspected recto-vaginal endometriosis based on clinical history and examination, suspected malignancy, pelvic inflammatory disease, active lower genital tract infection, virginity or pregnancy
  • Postpartum (immediate) tubal sterilization
  • Tubal sterilization during a cesarean section

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Route A: Traditional laparoscopy
Procedure: Traditional laparoscopy
Utilizes three or four ports for access and retrieval.
Experimental: Route B: Single site laparoscopy
Procedure: Single site laparoscopy
One port is placed via a 2 to 3 cm umbilical/fascia incision. With this technique, there is a single incision, hidden in the umbilicus.
Experimental: Route C:V-Notes surgery
Procedure: V-Notes surgery
One port placed trans-vaginally via a 2-3 cm vaginal incision with no abdominal scars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire
Time Frame: 24 hours after surgery
This questionnaire has 40 questions, score varies from 40 (poor)-200 (excellent) a higher number indicating a better outcome
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmesis as assessed by the Body Image Questionnaire
Time Frame: 2 weeks post surgery
This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image
2 weeks post surgery
Cosmesis as assessed by the Body Image Questionnaire
Time Frame: 6 weeks post surgery
This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image
6 weeks post surgery
Cosmesis as assessed by the Body Image Questionnaire
Time Frame: 3 months post surgery
This includes 5 questions and each is scored on a 4-point Likert scale from 1(no, not at all) to 4(yes, extremely) with a maximum score of 20 and higher score indicating a better body image
3 months post surgery
Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI)
Time Frame: Baseline, 3 months post surgery
This has 9 items that address sexual dysfunctions. Each of these items are scored on a six-point scale ranging from 0 to 5, higher the score the better sexual function.
Baseline, 3 months post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Time Frame: 24 hours post surgery
Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)
24 hours post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Time Frame: 2 weeks post surgery
Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)
2 weeks post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Time Frame: 6 weeks post surgery
Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)
6 weeks post surgery
Pain as assessed by the Resting Visual Analog Scale (VAS)
Time Frame: 3 months post surgery
Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain during a quiet breathing period (resting VAS)
3 months post surgery
Pain as assessed by the Dynamic Visual Analog Scale (VAS)
Time Frame: 3 months post surgery
Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain after a voluntary cough (dynamic VAS)
3 months post surgery
Patient satisfaction as assessed by the satisfaction scale
Time Frame: 3 months post surgery
Patients will rate their satisfaction on a 5 point Likert scale from 1(very unsatisfied) to 5(very satisfied)
3 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Randa J Jalloul, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2022

Primary Completion (Actual)

March 7, 2025

Study Completion (Actual)

June 5, 2025

Study Registration Dates

First Submitted

August 24, 2022

First Submitted That Met QC Criteria

August 25, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-22-0470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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