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

The University of Texas Health Science Center, Houston255 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

255

Conditions

Sterility, Female

Interventions

Traditional laparoscopyPROCEDURE

Utilizes three or four ports for access and retrieval.

Single site laparoscopyPROCEDURE

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.

V-Notes surgeryPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: 24 hours after surgery

Secondary Outcomes

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

Time frame: 2 weeks post surgery

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

Time frame: 6 weeks post surgery

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

Time frame: 3 months post surgery

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.

Time frame: Baseline, 3 months post surgery

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)

Data from ClinicalTrials.gov

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