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

The University of Texas System (UT)

Status: Enrolling

Conditions: Sterility, Female

Treatments: Device: V-Notes surgery; Device: Traditional laparoscopy; Device: Single site laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT05518175

HSC-MS-22-0470

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 3 patient groups

Route A: Traditional laparoscopy

Active Comparator group

Treatment:

Device: Traditional laparoscopy

Route B: Single site laparoscopy

Experimental group

Treatment:

Device: Single site laparoscopy

Route C:V-Notes surgery"

Experimental group

Treatment:

Device: V-Notes surgery