NCT02709460

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

March 4, 2016

Last Update Submit

March 11, 2019

Conditions

Postoperative Hemorrhage

Keywords

hematomacomplicationhysterectomy

Outcome Measures

Primary Outcomes (1)

  • Frequency of postoperative hematoma

    2 years

Study Arms (2)

Lateral occlusion

EXPERIMENTAL

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

Procedure: Lateral occlusion

cervical occlusion

ACTIVE COMPARATOR

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

Procedure: Cervical occlusion

Interventions

Lateral occlusionPROCEDURE

Lateral occlusion close to the internal Iliac artery

Lateral occlusion
Cervical occlusionPROCEDURE

Cervical occlusion of the uterine artery

cervical occlusion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women submitted to total laparoscopic hysterectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vibeke Lysdal

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Postoperative HemorrhageHematoma

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Central Study Contacts

Vibeke Lysdal, Consultant

CONTACT

+4560113333mr@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 16, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

December 1, 2019

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)