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

Primary Purpose

Sterility, Female

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Traditional laparoscopy

Single site laparoscopy

V-Notes surgery

About this trial

This is an interventional treatment trial for Sterility, Female focused on measuring laparoscopy, quality of recovery, vaginal natural orifice transluminal endoscopic surgery

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Route A: Traditional laparoscopy

Route B: Single site laparoscopy

Route C:V-Notes surgery"

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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.

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)

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)

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)

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)

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)

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)

Full Information

NCT ID

NCT05518175

First Posted

August 24, 2022

Last Updated

April 25, 2023

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT05518175

Brief Title

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

Acronym

POPS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2022 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sterility, Female

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Route A: Traditional laparoscopy

Arm Type

Active Comparator

Arm Title

Route B: Single site laparoscopy

Arm Type

Experimental

Arm Title

Route C:V-Notes surgery"

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Traditional laparoscopy

Intervention Description

Utilizes three or four 5 mm ports for access and retrieval.

Intervention Type

Device

Intervention Name(s)

Single site laparoscopy

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

V-Notes surgery

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Cosmesis as assessed by the Body Image Questionnaire

Description

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

Title

Cosmesis as assessed by the Body Image Questionnaire

Description

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

Title

Cosmesis as assessed by the Body Image Questionnaire

Description

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

Title

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

Description

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

Title

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

Description

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)

Time Frame

24 hours post surgery

Title

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

Description

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)

Time Frame

2 weeks post surgery

Title

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

Description

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)

Time Frame

6 weeks post surgery

Title

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

Description

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)

Time Frame

3 months post surgery

Title

Pain as assessed by the Dynamic Visual Analog Scale (VAS)

Description

Rating pain on a scale from 0 to 10, 0 is no pain and 10 is severe pain after a voluntary cough (dynamic VAS)

Time Frame

3 months post surgery

Title

Patient satisfaction as assessed by the satisfaction scale

Description

Patients will rate their satisfaction on a 5 point Likert scale from 1(very unsatisfied) to 5(very satisfied)

Time Frame

3 months post surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Randa J Jalloul, MD

Phone

713-566-5749

Randa.J.Jalloul@uth.tmc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sunbola S Ashimi Ademola

Phone

713-500-6410

Sunbola.S.Ashimi@uth.tmc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Randa J Jalloul, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Texas Health Science Center at Houston

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Randa Jalloul, MD

Phone

713-566-5749

Randa.J.Jalloul@uth.tmc.edu

First Name & Middle Initial & Last Name & Degree

Sunbola Ashimi Ademola

Phone

713-500-6410

Sunbola.S.Ashimi@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD

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

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