Comparing two methods for closing the vaginal vault after laparoscopic hysterectomy
Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy - a Single Blinded Randomized Comparative Study
This study is testing two different ways to close the vaginal area after laparoscopic hysterectomy to see which method has fewer complications for women with benign uterine conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06867614 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare two techniques for closing the vaginal vault after total laparoscopic hysterectomy: laparoscopic closure and transvaginal closure. The study will assess the risk of complications such as vaginal vault hematoma, vaginal cuff infection, and sexual dysfunction associated with each technique. Adult females with benign uterine conditions who are non-obese and sexually active will be included in the trial. The findings could provide valuable insights into the safest and most effective closure method for patients undergoing this procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adult females with benign uterine conditions who are non-obese and sexually active.
Not a fit: Patients with pelvic malignancy, obesity, or conditions that impair wound healing will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for women undergoing total laparoscopic hysterectomy.
How similar studies have performed: While there may be existing studies on surgical techniques for hysterectomy, this specific comparison of closure methods is less commonly explored, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cairo
- Ain Shams University maternity hospital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Rowan A Sakr
- Email: 150232@med.asu.edu.eg
- Phone: +201026141345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.