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

Sterility, Female Clinical Trial

— POPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518175
• Other study ID #: HSC-MS-22-0470
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Randa J Jalloul, MD
• Phone: 713-566-5749
• Email: Randa.J.Jalloul[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Sterility, Female

Intervention

Device:
• Traditional laparoscopy
Utilizes three or four 5 mm ports for access and retrieval.
• Single site laparoscopy
One port is placed via a 2 to 3 cm umbilical/fascia incision to accommodate the Gelpoint device, where several laparoscopic instruments are used. With this technique, there is a single incision, hidden in the umbilicus a
• V-Notes surgery
One port placed trans-vaginally via a 2-3 cm vaginal incision with no abdominal scars

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

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