Laparoscopic Versus Vaginal Approach Closure Complications

NCT ID: NCT05960292

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-04-30

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.

Conditions

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Vaginal Vault Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Vaginal Hysterectomy (Group)

About 28 female patients will have vaginal vault closure by vaginal approach

Group Type ACTIVE_COMPARATOR

Laparoscopic and Vaginal Hysterectomy

Intervention Type PROCEDURE

To make a comparison between the Vaginal Vault complications after Hysterectomy

Abdominal Laparoscopic Hysterectomy (Group)

About 28 female patients will have vaginal vault closure by Abdominal Laparoscopic approach

Group Type ACTIVE_COMPARATOR

Laparoscopic and Vaginal Hysterectomy

Intervention Type PROCEDURE

To make a comparison between the Vaginal Vault complications after Hysterectomy

Interventions

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Laparoscopic and Vaginal Hysterectomy

To make a comparison between the Vaginal Vault complications after Hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Egymedicalpedia

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ElSayed ElDesouky, Assist.Prof.

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University, Faculty of medicine for boys

Locations

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Al-Azhar University hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed Adel, MSC

Role: CONTACT

+201065702255

Facility Contacts

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ElSayed ElDesouky, Assist.Prof

Role: primary

01092934978

Other Identifiers

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Mohamed Adel Hussien

Identifier Type: -

Identifier Source: org_study_id

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