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

NCT05518175 | Completed

• 1 other identifier: HSC-MS-22-0470
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sterility, Female

Keywords

laparoscopy; quality of recovery; vaginal natural orifice transluminal endoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire

  This questionnaire has 40 questions, score varies from 40 (poor)-200 (excellent) a higher number indicating a better outcome

  24 hours after surgery

Secondary Outcomes (10)

• Cosmesis as assessed by the Body Image Questionnaire

  2 weeks post surgery

• Cosmesis as assessed by the Body Image Questionnaire

  6 weeks post surgery

• Cosmesis as assessed by the Body Image Questionnaire

  3 months post surgery

• Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI)

  Baseline, 3 months post surgery

• Pain as assessed by the Resting Visual Analog Scale (VAS)

  24 hours post surgery

Study Arms (3)

Route A: Traditional laparoscopy

ACTIVE COMPARATOR

Procedure: Traditional laparoscopy

Route B: Single site laparoscopy

EXPERIMENTAL

Procedure: Single site laparoscopy

Route C:V-Notes surgery

EXPERIMENTAL

Procedure: V-Notes surgery

Interventions

Traditional laparoscopy PROCEDURE

Utilizes three or four ports for access and retrieval.

Route A: Traditional laparoscopy

Single site laparoscopy PROCEDURE

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.

Route B: Single site laparoscopy

V-Notes surgery PROCEDURE

One port placed trans-vaginally via a 2-3 cm vaginal incision with no abdominal scars.

Route C:V-Notes surgery

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Randa J Jalloul, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: November 15, 2022
• Primary Completion: March 7, 2025
• Study Completion: June 5, 2025
• Last Updated: January 26, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)