Comparing Pain After Laparoscopic Hernia Repair Using Two... | NCT02467140

Studies
Comparing Pain After Laparoscopic Hernia Repair Using Two Different Types of Mesh Fixation

NCT02467140

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Jun 9, 2015Estimated

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Inguinal Hernia
Pain

Interventions

Parietex ProGrib self-fixating mesh
Tack fixation

Countries

Denmark

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

May 2015

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

May 2015

Primary Completion Date

May 2016Estimated

Completion Date

May 2017Estimated

First Submitted Date

Jun 4, 2015

First Submission Date that Met QC Criteria

Jun 5, 2015

First Posted Date

Jun 9, 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

Jun 5, 2015

Last Update Posted Date

Jun 9, 2015Estimated

Name	Class
Medtronic - MITG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation.

Detailed Description

The primary aim of this study is to evaluate acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation. The ProGripTM laparoscopic self-fixating mesh has been approved for implantation to reinforce the abdominal wall during laparoscopic inguinal hernia repair (TAPP). The mesh delivers tack free fixation above and below the inguinal ligament potentially eliminating pain associated with traditional tack fixation. The present study is a prospective randomized clinical trial designed to collect information about complications such as acute and chronic pain and hernia recurrence rate from patients referred for laparoscopic inguinal hernia repair. Patients who qualify to take part in the study will be randomized for a procedure using either a self-gripping ProGrip mesh or a conventional polypropylene mesh attached with AbsorbaTackTM. Data will be collected from operations performed at 6 high volume hernia centers in Denmark.

Patients eligible for study will be recruited from the referral list for inguinal hernia repair at each participating institution. Prior to scheduled surgery, patients will be consented and will complete a questionnaire on inguinal pain intensity and quality of life .

The mesh will be placed intraperitoneally after the component separation is complete. The peritoneal layer will be closed with a V-loc stitch in both groups.

After surgery, key clinical data will be recorded, such as type of mesh used, size of the hernia defect, number of tacks used etc.

The participating patients will receive postoperative questionnaires following the first year after surgery.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Self-fixating mesh	Active Comparator	During surgery, the Parietex ProGrib mesh will be used.	Device: Parietex ProGrib self-fixating mesh
Tack fixation	Active Comparator	During surgery, the mesh will be fixated with tacks.	Device: Tack fixation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Parietex ProGrib self-fixating mesh	Device	Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh.	Self-fixating mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients experiencing acute postoperative pain, using the NRS pain score.		3 months
Number of patients with recurrent hernia.		1 year

Secondary Outcomes

Measure	Description	Time Frame
Number of patients experiencing chronic postoperative pain, using the NRS pain score.		1 year
Quality of life before and after surgery, using the Carolina Comfort Scale		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for elective, inguinal hernia repair
18 years or older
Male gender
ASA physical classification system 1-3
Informed consent

Exclusion Criteria:

Patients with recurrent hernia, except patients operated in childhood without mesh application.
Patients with bilateral hernia
Patients with chronic pain
Patients in anticoagulation therapy
Previous major surgery in lower abdomen

Accepts Healthy Volunteers

Sex

Male

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

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Malene O Dinesen, MD PhD	Contact	+45 42 29 00 23		maledine@rm.dk
Marie K Christensen, MD	Contact	+45 40 79 54 59		mariekirk@dadlnet.dk

Overall Officials

Name	Affiliation	Role
Michael F Nielsen, MD PhD		Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospitalsenheden Midt	Recruiting	Viborg	Region Midt	8800	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal
D010146	Pain
D006547	Hernia

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided