Lateral Occlusion of Uterine Artery in Total Laparoscopic Hysterectomy
Primary Purpose
Postoperative Hemorrhage
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Lateral occlusion
Cervical occlusion
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Hemorrhage focused on measuring hematoma, complication, hysterectomy
Eligibility Criteria
Inclusion Criteria:
- Women submitted to total laparoscopic hysterectomy
Exclusion Criteria:
- Women <18 years
- Women no able to understand the study or not native in Danish
- Women with uterine malignancy
- Women with suspicion of pelvic mass
- Women with abnormal coagulation
- Women receiving glucocorticoid treatment
- Women receiving anticoagulant treatment or have not followed prescription in relation to surgery
Sites / Locations
- Vibeke LysdalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lateral occlusion
cervical occlusion
Arm Description
Women included in this arm is randomized to lateral occlusion of the uterine artery
Women included in this arm is randomized to occlusion of the uterine artery at cervical entry
Outcomes
Primary Outcome Measures
Frequency of postoperative hematoma
Secondary Outcome Measures
Full Information
NCT ID
NCT02709460
First Posted
March 4, 2016
Last Updated
March 11, 2019
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02709460
Brief Title
Lateral Occlusion of Uterine Artery in Total Laparoscopic Hysterectomy
Official Title
Lateral Versus Cervical Coagulation of the Uterine Artery in Benign Hysterectomy: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Laparoscopic hysterectomy is associated with complications in form of infections and subsequently dehiscence of the vault. This is a serious complication. The infection may be related to the frequently observed postoperative hematoma following traditional laparoscopic hysterectomy where the uterine artery is coagulated and divided at the cervical entry into the uterus.
By coagulation of the uterine artery laterally close to the internal iliac artery this problem may be eliminated due to the much less bleeding observed during this procedure.
Detailed Description
Laparoscopic hysterectomy (removal of the uterus) is today a well-described method for the removal of the uterus. The operation is offered in case of bleeding disorders where other treatments have been unsuccessful, uterine fibroids or other conditions requiring surgery with removal of the uterus.
The operation is done today in most cases by dividing the uterine artery at the entrance to the cervix, where the artery divides into one ascending and descending branch.
The most common complication of hysterectomy is bleeding perioperative well as postoperatively, which may result in a hematoma above the vaginal vault.
Through the years different methods have been tried to reduce this complication, including tranexamic acid without great success. The hematoma may result in infection postoperative and subsequent poor healing, with the possibility of dehiscence of the vault.
In the worst case, the gut is displaced through the vagina postoperatively. This condition can lead to diffuse peritonitis, which can be fatal in rare cases.
Since the hemostasis related to the dividing of the artery uterine can be problematic, especially in case of fibroids it may be a technical advantage to coagulate the Uterine artery at the exit of the Internal Iliac artery. This operation also ensures identification of the ureter, which can be spared. Lesions to the ureter are detected in up to 1% of all surgical procedures at hysterectomy.
Dividing of the Uterine artery at the Internal Iliac Artery also ensures that the artery can be divided with minimal bleeding at the cervix.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hemorrhage
Keywords
hematoma, complication, hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lateral occlusion
Arm Type
Experimental
Arm Description
Women included in this arm is randomized to lateral occlusion of the uterine artery
Arm Title
cervical occlusion
Arm Type
Active Comparator
Arm Description
Women included in this arm is randomized to occlusion of the uterine artery at cervical entry
Intervention Type
Procedure
Intervention Name(s)
Lateral occlusion
Intervention Description
Lateral occlusion close to the internal Iliac artery
Intervention Type
Procedure
Intervention Name(s)
Cervical occlusion
Intervention Description
Cervical occlusion of the uterine artery
Primary Outcome Measure Information:
Title
Frequency of postoperative hematoma
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women submitted to total laparoscopic hysterectomy
Exclusion Criteria:
Women <18 years
Women no able to understand the study or not native in Danish
Women with uterine malignancy
Women with suspicion of pelvic mass
Women with abnormal coagulation
Women receiving glucocorticoid treatment
Women receiving anticoagulant treatment or have not followed prescription in relation to surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vibeke Lysdal, Consultant
Phone
+4560113333
Email
mr@rsyd.dk
Facility Information:
Facility Name
Vibeke Lysdal
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Rudnicki, Professor
Phone
+45 60113333
Email
mr@rsyd.dk
First Name & Middle Initial & Last Name & Degree
Vibeke Lysdal, Consultant
Phone
+4560113333
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lateral Occlusion of Uterine Artery in Total Laparoscopic Hysterectomy
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