Sterility, Female
Conditions
Keywords
laparoscopy, quality of recovery, vaginal natural orifice transluminal endoscopic surgery
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.
Interventions
PROCEDURETraditional laparoscopy
Utilizes three or four ports for access and retrieval.
PROCEDURESingle 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.
PROCEDUREV-Notes surgery
One port placed trans-vaginally via a 2-3 cm vaginal incision with no abdominal scars.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery after surgery as assessed by the Quality of Recovery (QOR-40 )questionnaire | 24 hours after surgery | This questionnaire has 40 questions, score varies from 40 (poor)-200 (excellent) a higher number indicating a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmesis as assessed by the Body Image Questionnaire | 2 weeks post surgery | 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) | Baseline, 3 months post surgery | 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) | 24 hours post surgery | 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) | 3 months post surgery | 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 | 3 months post surgery | Patients will rate their satisfaction on a 5 point Likert scale from 1(very unsatisfied) to 5(very satisfied) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRanda J Jalloul, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed