A Modified Technique for Laparoscopic Subtotal Hysterectomy | NCT02328274

Studies
A Modified Technique for Laparoscopic Subtotal Hysterectomy

NCT02328274

Sponsor

Far Eastern Memorial Hospital

Status

Completed

Last Update Posted

Dec 31, 2014Estimated

Enrollment

19Actual

Phase

Not provided

Conditions

Subtotal Hysterectomy

Interventions

A Modified Technique for Laparoscopic Subtotal Hysterectomy

Countries

Not provided

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

Dec 2014

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 2014

Primary Completion Date

Sep 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Dec 25, 2014

First Submission Date that Met QC Criteria

Dec 25, 2014

First Posted Date

Dec 31, 2014Estimated

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

Dec 25, 2014

Last Update Posted Date

Dec 31, 2014Estimated

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

Laparoscopic subtotal hysterectomy (LASH) for benign uterine lesion has regained its popularity in the past decade due to its minimal invasiveness that results in less operation time, less blood loss and quicker return to normal activity. The standard surgical procedure in LASH includes separation of adnexa and round ligament from pelvic sidewall or uterus, dissection of the vesico-uterine peritoneum and opening of the paravesical space; followed by amputation of the uterus with energy-producing modalities (such as Harmonic Scalpel, monopolar electrocautery, bipolar electrocautery). Large uteri may result in longer operative time and higher possibility of conversion to laparotomy due to technical difficulty and excessive blood loss. In order to overcome these difficulties, we introduce a modified surgical technique of LASH which incorporated two methods of vessels ligation and laparoscopic in situ morcellation.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A Modified Technique for Laparoscopic Subtotal Hysterectomy	Procedure	incorporation of two methods of vessels ligation and laparoscopic in situ morcellation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operation time		at time of surgery
Intraoperative blood loss		at time of surgery

Secondary Outcomes

Measure	Description	Time Frame
Post-operative complications	such as ureteral injury, bowel perforation, conversion to laparotomy, recurrent vaginal bleeding	up to 7 days post operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients aged 20 years old and above with symtomatic uterine myomas or adenomyosis
complete medical record

Exclusion Criteria:

patients aged below 20 years old
uterine malignancy
incomplete medical record

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients aged 20 years old and above with symtomatic uterine myomas or adenomyosis

Sampling Method

Non-Probability Sample