Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy | NCT02879487

Studies
Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy

NCT02879487

Sponsor

Ankara University

Status

Completed

Last Update Posted

Sep 21, 2020Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Surgical Wound Dehiscence

Interventions

Monopolar needle electrode

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Aug 19, 2016

First Submission Date that Met QC Criteria

Aug 21, 2016

First Posted Date

Aug 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2020

Last Update Posted Date

Sep 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Monopolar needle electrode	Device	Colpotomy during total laparoscopic hysterectomy	Coagulation mode Cut mode

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaginal dehiscence	Vaginal dehiscence up to 3 months after surgery	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emre Şükür, MD	Ankara University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara University Medical Faculty Hospital		Ankara		06100	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013529	Surgical Wound Dehiscence

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided