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

Pain Clinical Trial

Official title:

A Clinical Study of Postoperative Pain Following Laparoscopic Transabdominal Preperitoneal Inguinal Hernioplasty. Comparing Parietex ProGrib With Tacks for Mesh Fixation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02467140
• Other study ID #: 2307PG
• Status: Recruiting
• Phase: N/A
• First received: June 4, 2015
• Last updated: June 5, 2015
• Start date: May 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2015
• Source: University of Aarhus
• Contact: Malene O Dinesen, MD PhD
• Phone: +45 42 29 00 23
• Email: maledine[@]rm.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain

Intervention

Device:
• Parietex ProGrib self-fixating mesh
Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh.
• Tack fixation
Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh using tack fixation.

Locations

Country	Name	City	State
Denmark	Hospitalsenheden Midt	Viborg	Region Midt

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Medtronic - MITG

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients experiencing acute postoperative pain, using the NRS pain score.		3 months	No
Primary	Number of patients with recurrent hernia.		1 year	No
Secondary	Number of patients experiencing chronic postoperative pain, using the NRS pain score.		1 year	No
Secondary	Quality of life before and after surgery, using the Carolina Comfort Scale		6 months	No