Lateral Occlusion of Uterine Artery in Total Laparoscopic Hysterectomy

NCT ID: NCT02709460

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-12-01

Brief Summary

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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

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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.

Conditions

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Postoperative Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lateral occlusion

Women included in this arm is randomized to lateral occlusion of the uterine artery

Group Type EXPERIMENTAL

Lateral occlusion

Intervention Type PROCEDURE

Lateral occlusion close to the internal Iliac artery

cervical occlusion

Women included in this arm is randomized to occlusion of the uterine artery at cervical entry

Group Type ACTIVE_COMPARATOR

Cervical occlusion

Intervention Type PROCEDURE

Cervical occlusion of the uterine artery

Interventions

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Lateral occlusion

Lateral occlusion close to the internal Iliac artery

Intervention Type PROCEDURE

Cervical occlusion

Cervical occlusion of the uterine artery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Vibeke Lysdal

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vibeke Lysdal

Odense, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Vibeke Lysdal, Consultant

Role: CONTACT

+4560113333

Facility Contacts

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Martin Rudnicki, Professor

Role: primary

+45 60113333

Vibeke Lysdal, Consultant

Role: backup

+4560113333

Other Identifiers

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S-20140104

Identifier Type: -

Identifier Source: org_study_id

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