Laparoscopic Versus Vaginal Approach Closure Complications

Not Applicable

Recruiting

• Conditions: Vaginal Vault Prolapse
• Interventions: Procedure: Laparoscopic and Vaginal Hysterectomy

• Registration Number: NCT05960292
• Lead Sponsor: Egymedicalpedia

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-21
• Study First Posted: 2023-07-25
• Study Start: 2023-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 56

Inclusion Criteria

1. Patients who undergo laparoscopic hysterectomy
2. Age ranged from 40 to 80 years.
3. Patients suffering from chronic pelvic inflammatory disease (PID)
4. Dysfunctional uterine bleeding
5. Adenomyosis
6. Endometriosis
7. Fibroid
8. Endometrial hyperplasia
9. Benign ovarian cyst

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Exclusion Criteria

• Patients with known malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal Hysterectomy (Group)	Laparoscopic and Vaginal Hysterectomy	About 28 female patients will have vaginal vault closure by vaginal approach
Abdominal Laparoscopic Hysterectomy (Group)	Laparoscopic and Vaginal Hysterectomy	About 28 female patients will have vaginal vault closure by Abdominal Laparoscopic approach

Primary Outcome Measures

Name	Time	Method
Post operative bleeding (defined as blood loss ≥500 cc)	First 24 hours after The Operations	Amount of lost blood will be measured in terms of assessment of Hemoglobin and Hematocrit levels before and after operation.
Postoperative pain	First 24 hours after The Operations	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

Trial Locations

Locations (1)

Al-Azhar University hospitals; 🇪🇬 Cairo, Egypt