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

NCT ID: NCT05518175

Last Updated: 2026-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2025-06-05

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.

Detailed Description

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Conditions

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Sterility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Route A: Traditional laparoscopy

Group Type ACTIVE_COMPARATOR

Traditional laparoscopy

Intervention Type PROCEDURE

Utilizes three or four ports for access and retrieval.

Route B: Single site laparoscopy

Group Type EXPERIMENTAL

Single site laparoscopy

Intervention Type PROCEDURE

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.

Route C:V-Notes surgery

Group Type EXPERIMENTAL

V-Notes surgery

Intervention Type PROCEDURE

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

Interventions

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Traditional laparoscopy

Utilizes three or four ports for access and retrieval.

Intervention Type PROCEDURE

Single site laparoscopy

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.

Intervention Type PROCEDURE

V-Notes surgery

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Randa Jalloul

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Randa J Jalloul, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-22-0470

Identifier Type: -

Identifier Source: org_study_id

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