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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

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
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
  • Device: Traditional laparoscopy
    Utilizes three or four 5 mm ports for access and retrieval.
Experimental
Route B: Single site laparoscopy
  • Device: Single site laparoscopy
    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
Experimental
Route C:V-Notes surgery"
  • Device: V-Notes surgery
    One port placed trans-vaginally via a 2-3 cm vaginal incision with no abdominal scars

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Randa Jalloul, MD
713-566-5749
Randa.J.Jalloul@uth.tmc.edu

More Details

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

Study Contact

Randa J Jalloul, MD
713-566-5749
Randa.J.Jalloul@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.