Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP)... | NCT02561910

Studies
Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results

NCT02561910

Sponsor

Hernia Center Rottenburg

Status

Completed

Last Update Posted

Sep 28, 2015Estimated

Enrollment

952Actual

Phase

Not provided

Conditions

Unilateral Inguinal Hernia With Gangrene and Obstruction

Interventions

Laparoscopic hernia repair

Countries

Germany

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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 2015

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

Jan 2000

Primary Completion Date

Dec 2008Actual

Completion Date

Aug 2015Actual

First Submitted Date

Sep 25, 2015

First Submission Date that Met QC Criteria

Sep 25, 2015

First Posted Date

Sep 28, 2015Estimated

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 25, 2015

Last Update Posted Date

Sep 28, 2015Estimated

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 effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one year period a total of 1208 inguinal hernias in 952 patients were consecutively operated using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine.

Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the standard procedure in inguinal hernia repair in future.

Detailed Description

Objective:

Hernia repair is the most frequent operation in general surgery worldwide, but about 25 years after the advent of minimal invasive surgical techniques the effectiveness of laparoscopic inguinal hernia repair still remains unclear.

Methods:

All patients admitted to the hospital for surgery of an inguinal hernia during a one year period were prospectively documented and included in a follow-up study. The follow-up was performed at least 5 years after surgery and consisted of a clinical examination, ultrasound investigation and a questionnaire.

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

952Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic hernia repair	Device	Preperitoneal mesh implantation because of inguinal hernia disease using the laparoscopic technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome of the trial was recurrence of a hernia within five years after the repair.		5 years

Secondary Outcomes

Measure	Description	Time Frame
The secondary outcome was chronic pain.	Chronic pain was measured by VAS scale	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients fit for general anesthesia and presenting an inguinal hernia.

Exclusion Criteria:

Not fit for general anesthesia, young age (>21 years), not wanting a mesh.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients admitted for hernia surgery during a one year period (n=928) were operated exclusively in TAPP technique and were assigned to follow-up.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Reinhard Bittner, M.D.	Hernia Center Rottenburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hernia Center		Rottenburg		72108	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24035088	Background	Cavazzola LT, Rosen MJ. Laparoscopic versus open inguinal hernia repair. Surg Clin North Am. 2013 Oct;93(5):1269-79. doi: 10.1016/j.suc.2013.06.013.

Type	Date	Date Unknown
Release	Sep 29, 2015
Reset	Oct 27, 2015
Release	Dec 6, 2015
Reset	Jan 12, 2016

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 29, 2015			Oct 27, 2015
Dec 6, 2015

ID	Term
D011041	Poisoning
D064419	Chemically-Induced Disorders
D014947	Wounds and Injuries