Laparoscopic Versus Vaginal Approach Closure Complications

Vaginal Vault Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05960292
• Other study ID #: Mohamed Adel Hussien
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: September 2023
• Source: Egymedicalpedia
• Contact: Mohamed Adel, MSC
• Phone: +201065702255
• Email: elhoseeeeeeny[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: April 30, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 80 Years

Eligibility

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

Exclusion Criteria:

• Patients with known malignancy

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Vaginal Vault Prolapse

Intervention

Procedure:
• Laparoscopic and Vaginal Hysterectomy
To make a comparison between the Vaginal Vault complications after Hysterectomy

Locations

Country	Name	City	State
Egypt	Al-Azhar University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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