Laparoscopic Versus Vaginal Approach Closure Complications

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Vault Prolapse
• Intervention / Treatment: Procedure: Laparoscopic and Vaginal Hysterectomy

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 Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Adel, MSC; Phone Number: +201065702255; Email: elhoseeeeeeny@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 13111
    • Recruiting
    • Al-Azhar University Hospitals
    • Contact: ElSayed ElDesouky, Assist.Prof; Phone Number: 01092934978; Email: elsayedeldesouky@yahoo.com
    • Principal Investigator: Ahmed Altaf, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Vaginal hysterectomy; Laparoscopic hysterectomy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: Mohamed Adel Hussien

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No