Laparoscopic Versus Vaginal Approach Closure Complications

Study Overview
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Brief Summary
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Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally. The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs.

Detailed Description
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Laparoscopic hysterectomy (LH) is a minimally invasive operation that could be made when vaginal hysterectomy is not accessible due to anatomical problems. Vaginal cuff dehiscence (VCD) is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (TLH) compared with abdominal and vaginal hysterectomy. The study shows effects of the laparoscopic approach versus the vaginal route for the management of vaginal cuff closure during total laparoscopic hysterectomy on female sexual function.

Official Title
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Laparoscopic Versus Vaginal Approach Closure Complications of Vaginal Vault in Laparoscopic Hysterectomy

Conditions
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Vaginal Vault Prolapse

Intervention / Treatment
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* Procedure: Laparoscopic and Vaginal Hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who undergo laparoscopic hysterectomy Age ranged from 40 to 80 years. Patients suffering from chronic pelvic inflammatory disease (PID) Dysfunctional uterine bleeding Adenomyosis Endometriosis Fibroid Endometrial hyperplasia Benign ovarian cyst Exclusion Criteria: Patients with known malignancy

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vaginal Hysterectomy (Group)<br>About 28 female patients will have vaginal vault closure by vaginal approach | Procedure: Laparoscopic and Vaginal Hysterectomy<br>* To make a comparison between the Vaginal Vault complications after Hysterectomy<br>|
| Active Comparator: Abdominal Laparoscopic Hysterectomy (Group)<br>About 28 female patients will have vaginal vault closure by Abdominal Laparoscopic approach | Procedure: Laparoscopic and Vaginal Hysterectomy<br>* To make a comparison between the Vaginal Vault complications after Hysterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative bleeding (defined as blood loss ≥500 cc) | Amount of lost blood will be measured in terms of assessment of Hemoglobin and Hematocrit levels before and after operation. | First 24 hours after The Operations | 
| Postoperative pain | Assessment of the pain post-operatively in patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain | First 24 hours after The Operations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic hysterectomy, Vaginal hysterectomy