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

Not Applicable

Recruiting

• Conditions: Sterility, Female
• Interventions: Device: Traditional laparoscopy; Device: Single site laparoscopy; Device: V-Notes surgery

• Registration Number: NCT05518175
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-25
• Study First Posted: 2022-08-26
• Study Start: 2022-11-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Route A: Traditional laparoscopy	Traditional laparoscopy	-
Route B: Single site laparoscopy	Single site laparoscopy	-
Route C:V-Notes surgery"	V-Notes surgery	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction as assessed by the satisfaction scale	3 months post surgery	Patients will rate their satisfaction on a 5 point Likert scale from 1(very unsatisfied) to 5(very satisfied)
Pain as assessed by the Resting Visual Analog Scale (VAS)	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)
Cosmesis as assessed by the Body Image Questionnaire	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
Change in sexual function as assessed by the Short version of the Female Sexual Function Index (FSFI)	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.
Pain as assessed by the Dynamic Visual Analog Scale (VAS)	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)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States