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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sterility, Female

Intervention / Treatment
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* Device: Traditional laparoscopy
* Device: Single site laparoscopy
* Device: V-Notes surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Route A: Traditional laparoscopy<br> | Device: Traditional laparoscopy<br>* Utilizes three or four 5 mm ports for access and retrieval.<br>|
| Experimental: Route B: Single site laparoscopy<br> | Device: Single site laparoscopy<br>* 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<br>|
| Experimental: Route C:V-Notes surgery<br> | Device: V-Notes surgery<br>* One port placed trans-vaginally via a 2-3 cm vaginal incision with no abdominal scars<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, quality of recovery, vaginal natural orifice transluminal endoscopic surgery