Total Laparoscopic Hystrectomy Versus Total Abdominal Hys... | NCT03407846

Studies
Total Laparoscopic Hystrectomy Versus Total Abdominal Hystrectomy

NCT03407846

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Mar 12, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Effect of Learning Curve on Operative Time in TLH and Comparing it to TAH

Interventions

Hystrectomy

Countries

Egypt

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2016Actual

Primary Completion Date

Sep 1, 2018Estimated

Completion Date

Sep 22, 2018Estimated

First Submitted Date

Sep 20, 2017

First Submission Date that Met QC Criteria

Jan 16, 2018

First Posted Date

Jan 23, 2018Actual

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

Mar 8, 2018

Last Update Posted Date

Mar 12, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

100 patient will be recruited for hystrectomy for benign cause and TLH will be copared to TAH and effect of learning curve will be assessed by comparing operative time between early and lat patients in TLH group

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Total laparscopic hystrectomy	Active Comparator		Procedure: Hystrectomy
Total abdominal hystrectomy	Experimental		Procedure: Hystrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hystrectomy	Procedure	Total laparscopic hystrectomy versus total abdominal hystrectomy	Total abdominal hystrectomy Total laparscopic hystrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operative time	Time in both type of hystrectomy will be compared and learning curve will be assesd among TLH group by comparing early cases to late	2 years

Secondary Outcomes

Measure	Description	Time Frame
Blood loss, coplications, postoperative pain	Hb measurment , and visual scale for pain	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Age. More than 40 Uterine size less than 14 weeks No contraindications for laparscopic surgery Benign cause for hystrectomy

Exclusion Criteria:

virgins Malignancy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams university	Recruiting	Cairo		22222	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Kept with researcher as cds for patients

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided