Quality of Life of TEP vs Lichtenstein Hernioplasty | NCT02723045

Studies
Quality of Life of TEP vs Lichtenstein Hernioplasty

NCT02723045

Sponsor

Sarawak General Hospital

Status

Unknown status

Last Update Posted

Mar 30, 2016Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

Open Lichtenstein Hernioplasty
Laparoscopic TEP Hernioplasty

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

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Oct 2016Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Mar 14, 2016

First Submission Date that Met QC Criteria

Mar 24, 2016

First Posted Date

Mar 30, 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

Mar 24, 2016

Last Update Posted Date

Mar 30, 2016Estimated

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

To determine if there is a difference in the quality of life in between patients who undergoes laparoscopic totally extra-peritoneal (TEP) or modified Lichtenstein hernioplasty

Detailed Description

Patients presenting with reducible inguinal hernias will be randomized between open or laparoscopic repair groups. The primary outcome will be the quality of life scores. Patients will be followed-up for 12 months.

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
Open modified Lichtenstein repair	Active Comparator	Patients will undergo open repair of their inguinal hernias	Procedure: Open Lichtenstein Hernioplasty
Laparoscopic TEP inguinal hernia repair	Active Comparator	Patients will undergo laparoscopic repair of their inguinal hernias	Procedure: Laparoscopic TEP Hernioplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Open Lichtenstein Hernioplasty	Procedure		Open modified Lichtenstein repair
Laparoscopic TEP Hernioplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life	Carolina Comfort Scale	12 months

Secondary Outcomes

Measure	Description	Time Frame
Operating time		12 months
Duration of hospitalization		12 months
Complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age and older
Both genders
Unilateral inguinal hernias
Reducible inguinal hernias
Elective setting

Exclusion Criteria

ASA Physical Status (American Society of Anaesthesiologists) Grade > 2
Recurrence
Inguinal-scrotal hernias
Prostatectomy, Pfannenstiel incision, previous pre-peritoneal surgery
Pregnancy
Refusal for general anaesthesia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided