Lateral Occlusion of Uterine Artery in Total Laparoscopic Hysterectomy

Lateral Versus Cervical Coagulation of the Uterine Artery in Benign Hysterectomy: A Randomized Controlled Study

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Hemorrhage
• Intervention / Treatment: Procedure: Lateral occlusion; Procedure: Cervical occlusion

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Recruiting
    • Vibeke Lysdal
    • Contact: Martin Rudnicki, Professor; Phone Number: +45 60113333; Email: mr@rsyd.dk
    • Contact: Vibeke Lysdal, Consultant; Phone Number: +4560113333

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lateral occlusion; Women included in this arm is randomized to lateral occlusion of the uterine artery	Procedure: Lateral occlusion; Lateral occlusion close to the internal Iliac artery
Active Comparator: cervical occlusion; Women included in this arm is randomized to occlusion of the uterine artery at cervical entry	Procedure: Cervical occlusion; Cervical occlusion of the uterine artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of postoperative hematoma	2 years

Collaborators and Investigators

• Sponsor: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 16, 2016

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: hysterectomy; complication; hematoma
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage
• Other Study ID Numbers: S-20140104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No