NCT02879487

Brief Summary

The aim of this study is to assess a major complication of total laparoscopic hysterectomy, vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be operated for laparoscopic hysterectomy will be randomized to two different techniques. The colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the second group. All of the operations will be preformed by the same surgical at a university hospital. Vaginal dehiscence after surgery is the primary outcome measure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

August 19, 2016

Last Update Submit

September 18, 2020

Conditions

Surgical Wound Dehiscence

Outcome Measures

Primary Outcomes (1)

  • Vaginal dehiscence

    Vaginal dehiscence up to 3 months after surgery

    3 months

Study Arms (2)

Coagulation mode

ACTIVE COMPARATOR

Colpotomy will be performed by monopolar needle electrode using coagulation mode

Device: Monopolar needle electrode

Cut mode

ACTIVE COMPARATOR

Colpotomy will be performed by monopolar needle electrode using cut mode

Device: Monopolar needle electrode

Interventions

Monopolar needle electrodeDEVICE

Colpotomy during total laparoscopic hysterectomy

Coagulation modeCut mode

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All total laparoscopic hysterectomies performed by a single surgeon
  • Both benign and malignant cases
  • Completed laparoscopically
  • Intracorporeal vaginal cuff suturing

You may not qualify if:

  • Robotic hysterectomies
  • Pelvic infection within 30 days before surgery
  • Conversion to laparotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Medical Faculty Hospital

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Emre Şükür, MD

    Ankara University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 25, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Locations

TU(1)