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

Purpose

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.

Condition

  • Sterility, Female

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Route A: Traditional laparoscopy
  • Procedure: Traditional laparoscopy
    Utilizes three or four ports for access and retrieval.
Experimental
Route B: Single site laparoscopy
  • 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.
Experimental
Route C:V-Notes surgery
  • Procedure: V-Notes surgery
    One port placed trans-vaginally via a 2-3 cm vaginal incision with no abdominal scars.

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact