Total Laparoscopic Hysterectomy
Conditions
Brief summary
The goal of this clinical trial is to compare the laparoscopic and transvaginal closure techniques of the vaginal vault in patients who perform TLH, regarding the risk of vaginal vault hematoma and other complications as vaginal cuff infection and sexual dysfunction.
Interventions
PROCEDURETotal laparoscopic hysterectomy
Removal of uterus and cervix by laparoscope
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Adult females consenting to do TLH all age groups with diagnoses of benign uterine conditions. * Women who are non-obese (normal or overweight women with BMI range 18-29.9). * Sexually active female.
Exclusion criteria
* Diagnosed cases of pelvic malignancy * Diagnosed patients with Cervical intraepithelial neoplasia (CIN) or bacterial vaginosis (any infection should be treated) * Obese patients. * Patients currently undergoing treatment for any type of cancer * Patients with coagulopathy, bleeding/clotting disorders * Patients with any condition can impair wound healing: diabetes mellites, anemia, steroids * Patients with a previous history of radiation and allergy to sutures * Patients with clinically evident prolapse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Vault hematoma | From 10 days postoperative to 30 days postoperative | It will be assessed by examination and ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal cuff granulation | From 10 days postoperative to 30 days postoperative | It will be assessed by examination and ultrasound |
| Bleeding/spotting | From 10 days postoperative to 30 days postoperative | I wil be assed by history and examination |
| Vaginal infection: | From 10 days postoperative to 30 days postoperative | It will be assessed by history and examination |
| Vaginal prolapse | From 10 days postoperative to 30 days postoperative | It will be assessed by history and examination |
| Sexual dysfunction | From 3 to 4 months post operative | I will be assessed through Female Sexual Function Index (FSFI) questionnaire |
Countries
Egypt
Contacts
Primary ContactRowan A Sakr
Outcome results
None listed