Back to resultsLaparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions
Primary Purpose
Uterine Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bakay purse string
Cuff closure via vaginal route group
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Diseases focused on measuring TLH, Bakay purse string
Eligibility Criteria
Inclusion Criteria: Benign uterine lesions e.g fibroid, adenomyosis,…etc. Patient acceptance to undergo laparoscopic hysterectomy. Exclusion Criteria: Gynecological malignancy. Low corporeal myoma obsecuring cervicovaginal junction. History of extensive abdominal surgery other than cesarean section.
Sites / Locations
- Obstetrics and Gynecology Department in Mansoura University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bakay purse string group
Cuff closure via vaginal route group
Arm Description
Bakay purse string will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.
Vaginal cuff closure via vaginal route with continuous locked suturing will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.
Outcomes
Primary Outcome Measures
Total operative time
The time between placement of the operative ports and successful closure of the vaginal cuff
Operative time for colpotomy and vaginal cuff closure
The time between first anchor suture placement and successful closure of the vaginal cuff
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05823935
Brief Title
Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions
Official Title
Laparoscopic Versus Vaginal Cuff Closure During Laparoscopic Hysterectomy in Benign Gynecological Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare vaginal cuff closure via Bakay purse string with vaginal cuff closure via vaginal route with continuous locked suturing after total laparoscopic hysterectomy for benign lesions.
Detailed Description
The objective of the present study is to compare 2 different methods for vaginal cuff closure after total laparoscopic hysterectomy for benign lesions regarding operative time, vaginal length, vaginal cuff dehiscene, hematoma formation. The first method is the Bakay purse string and the second is the closure of the vault via vaginal route with continuous locked suturing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Diseases
Keywords
TLH, Bakay purse string
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bakay purse string group
Arm Type
Active Comparator
Arm Description
Bakay purse string will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.
Arm Title
Cuff closure via vaginal route group
Arm Type
Active Comparator
Arm Description
Vaginal cuff closure via vaginal route with continuous locked suturing will be used to close the vaginal cuff after total laparoscopic hysterectomy for benign lesions.
Intervention Type
Procedure
Intervention Name(s)
Bakay purse string
Intervention Description
After developing the bladder flap, Vicryl polyglactin 910 sutures (Ethicon, Inc, Somerville, NJ) will be placed on the line between the cervicovaginal junction and the bladder starting at either 4 to 3 o'clock or 8 to 9 o'clock, as anchor sutures. Paying attention not to get closer than 1 cm to the bladder, the first suture will be passed from 4 o'clock to 3 o'clock and continued circumferentially in a full-thickness purse string fashion through 3, 1, 10, 8, 7, 5 o'clock completing a circle while including both uterosacral ligaments.
Intervention Type
Procedure
Intervention Name(s)
Cuff closure via vaginal route group
Intervention Description
After the uterus will be removed via vaginal route, vaginal cuff ends will be grasped via vaginal approach and sutured continuous locked sutures using Vicryl polyglactin 910 sutures in one layer.
Primary Outcome Measure Information:
Title
Total operative time
Description
The time between placement of the operative ports and successful closure of the vaginal cuff
Time Frame
From start to end of operation
Title
Operative time for colpotomy and vaginal cuff closure
Description
The time between first anchor suture placement and successful closure of the vaginal cuff
Time Frame
From start colpotomy to end of vaginal cuff closure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Benign uterine lesions e.g fibroid, adenomyosis,…etc.
Patient acceptance to undergo laparoscopic hysterectomy.
Exclusion Criteria:
Gynecological malignancy.
Low corporeal myoma obsecuring cervicovaginal junction.
History of extensive abdominal surgery other than cesarean section.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Elashry, MSc
Phone
+201066556370
Email
elashry11090@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed S Abdelhafez, MD
Email
msabdelhafez@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed M Elashry, MSc
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hamed M Youssef, MD
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maged R Elshamy, MD
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahmoud M Awad, MD
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, MD
Organizational Affiliation
Mansoura University
Official's Role
Study Director
Facility Information:
Facility Name
Obstetrics and Gynecology Department in Mansoura University Hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Laparoscopic Versus Vaginal Cuff Closure During LH in Benign Gynecological Lesions
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