Lateral Occlusion of Uterine Artery in Total Laparoscopic Hysterectomy

Postoperative Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02709460
• Other study ID #: S-20140104
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2019
• Source: Odense University Hospital
• Contact: Vibeke Lysdal, Consultant
• Phone: +4560113333
• Email: mr[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postoperative Hemorrhage

Intervention

Procedure:
• Lateral occlusion
Lateral occlusion close to the internal Iliac artery
• Cervical occlusion
Cervical occlusion of the uterine artery

Locations

Country	Name	City	State
Denmark	Vibeke Lysdal	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of postoperative hematoma		2 years