Laparoscopic Versus Transvaginal Closure of the Vaginal Vault After Total Laparoscopic Hysterectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total laparoscopic hysterectomy

    Procedure/Surgery

    Removal of uterus and cervix by laparoscope

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Vaginal approachActive comparator 1 intervention
Group B: Laparoscopic approachActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Vaginal Vault hematoma

It will be assessed by examination and ultrasound

Time frame
From 10 days postoperative to 30 days postoperative

Secondary outcomes

1

Bleeding/spotting

I wil be assed by history and examination

Time frame
From 10 days postoperative to 30 days postoperative
2

Vaginal infection:

It will be assessed by history and examination

Time frame
From 10 days postoperative to 30 days postoperative
3

Vaginal prolapse

It will be assessed by history and examination

Time frame
From 10 days postoperative to 30 days postoperative
4

Vaginal cuff granulation

It will be assessed by examination and ultrasound

Time frame
From 10 days postoperative to 30 days postoperative

Other outcomes

Sponsors and contacts

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