Laparoscopic Versus Vaginal Approach Closure Complications

Sponsor

Egymedicalpedia (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05960292

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Vault Prolapse	Procedure: Laparoscopic and Vaginal Hysterectomy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Vaginal Hysterectomy (Group)

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

Procedure: Laparoscopic and Vaginal Hysterectomy

To make a comparison between the Vaginal Vault complications after Hysterectomy

Active Comparator: Abdominal Laparoscopic Hysterectomy (Group)

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

Procedure: Laparoscopic and Vaginal Hysterectomy

To make a comparison between the Vaginal Vault complications after Hysterectomy

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al-Azhar University hospitals	Cairo		Egypt	13111

Sponsors and Collaborators

Egymedicalpedia

Investigators

Principal Investigator: ElSayed ElDesouky, Assist.Prof., Al-Azhar University, Faculty of medicine for boys

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Egymedicalpedia

ClinicalTrials.gov Identifier:

NCT05960292

Other Study ID Numbers:

Mohamed Adel Hussien

First Posted:

Jul 25, 2023

Last Update Posted:

Jul 25, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Egymedicalpedia

Laparoscopic hysterectomy

Vaginal hysterectomy

Additional relevant MeSH terms:

Prolapse

Pelvic Organ Prolapse

Study Results

No Results Posted as of Jul 25, 2023