Benign Conditions, Total Laparoscopic Hysterectomy
Conditions
Brief summary
American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive methods in gynecological surgery to ensure increased benefits to the patient and reduce potential hospitalization costs. Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures, techniques and approaches, which is one of the challenges of this surgery. Data is limited on potential impact of different sutures, techniques and approaches for vaginal cuff closure on female sexual function in relation to vaginal length. Various studies in the literature evaluated different approaches (abdominal, vaginal, laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures like operation time, cuff healing, complications, cost effectiveness, etc. were usually measured. However, there is no prospective randomized clinical study in the literature that compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual function in relation to vaginal length.
Interventions
PROCEDURECuff closure via vaginal route
Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.
PROCEDURECuff closure via laparoscopic route
Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.
Sponsors
University of Surrey
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to have total laparoscopic hysterectomy because of benign conditions only
Exclusion criteria
* Suspicion of malignancy * Presence of large adnexal masses (maximum diameter \>10 cm at preoperative ultrasonography)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function | Three months | Patients will be asked to fill out female sexual function index (FSFI) prior to surgery and at the 3-month follow-up. |
| Vaginal length | One months | Vaginal measure will be taken prior to surgery and at 1-month follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal cuff granulation/infection | One month | Vaginal cuff granulation and any evidence of vaginal cuff infection will be carefully examined and documented during the 4-week follow-up visit |
| Vaginal cuff closure time | One day | Cuff closure time will be recorded for each patient during the surgery. |
Countries
Turkey (Türkiye)
Outcome results
None listed