Back to resultsLaparoscopic Versus Vaginal Approach Closure Complications
Primary Purpose
Vaginal Vault Prolapse
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic and Vaginal Hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Vault Prolapse focused on measuring Laparoscopic hysterectomy, Vaginal hysterectomy
Eligibility Criteria
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
Sites / Locations
- Al-Azhar University hospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vaginal Hysterectomy (Group)
Abdominal Laparoscopic Hysterectomy (Group)
Arm Description
About 28 female patients will have vaginal vault closure by vaginal approach
About 28 female patients will have vaginal vault closure by Abdominal Laparoscopic approach
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05960292
Brief Title
Laparoscopic Versus Vaginal Approach Closure Complications
Official Title
Laparoscopic Versus Vaginal Approach Closure Complications of Vaginal Vault in Laparoscopic Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Vault Prolapse
Keywords
Laparoscopic hysterectomy, Vaginal hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaginal Hysterectomy (Group)
Arm Type
Active Comparator
Arm Description
About 28 female patients will have vaginal vault closure by vaginal approach
Arm Title
Abdominal Laparoscopic Hysterectomy (Group)
Arm Type
Active Comparator
Arm Description
About 28 female patients will have vaginal vault closure by Abdominal Laparoscopic approach
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic and Vaginal Hysterectomy
Intervention Description
To make a comparison between the Vaginal Vault complications after Hysterectomy
Primary Outcome Measure Information:
Title
Post operative bleeding (defined as blood loss ≥500 cc)
Description
Amount of lost blood will be measured in terms of assessment of Hemoglobin and Hematocrit levels before and after operation.
Time Frame
First 24 hours after The Operations
Title
Postoperative pain
Description
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
Time Frame
First 24 hours after The Operations
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Adel, MSC
Phone
+201065702255
Email
elhoseeeeeeny@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ElSayed ElDesouky, Assist.Prof.
Organizational Affiliation
Al-Azhar University, Faculty of medicine for boys
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Azhar University hospitals
City
Cairo
ZIP/Postal Code
13111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ElSayed ElDesouky, Assist.Prof
Phone
01092934978
Email
elsayedeldesouky@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ahmed Altaf, Professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Laparoscopic Versus Vaginal Approach Closure Complications
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