Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00749268
Other study ID # AS08011
Secondary ID
Status Completed
Phase Phase 4
First received September 8, 2008
Last updated September 9, 2015
Start date October 2008
Est. completion date November 2012

Study information

Verified date September 2015
Source Medtronic - MITG
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardFrance: Institutional Ethical CommitteeGermany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent methods of mesh fixation in inguinal and ventral hernia repair.


Recruitment information / eligibility

Status Completed
Enrollment 216
Est. completion date November 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ability and willingness to provide written informed consent and comply with the schedule of protocol assessments

- Age > 18 years

- Subjects undergoing laparoscopic hernia repair with Parietex or Parietex Composite reinforcements depending on indication and fixation of reinforcements with helical tackers (ProTack, Covidien) or absorbable tacks (AbsorbaTack, Covidien) in accordance with recommendations for use

Exclusion Criteria:

- Pregnancy

- Patients considered to have greater than reasonable surgical risk associated with general anesthesia and laparoscopic hernia repair

- Known active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics within 30 days prior to screening

- History of alcohol or drug abuse within 6 months prior to screening

- History of chronic pain condition requiring more than 30 days of medical management

- Use of an additional nonresorbable means of fixation (inguinal)

- Patients considered not able to comply with the protocol and follow up schedule

- ASA grade of 4 or above

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Device:
AbsorbaTack
Comparison of different devices for mesh fixation. This intervention arm has absorbable tacks as the method of hernia mesh fixation. Application is during hernia repair and tacks will essentially absorb within the body after 1 year.
ProTack
Comparison of different devices for mesh fixation. This intervention is a permanent tack for hernia mesh fixation. Application is during hernia repair and the tacks will remain in the body.

Locations

Country Name City State
United States University Hospitals at Case Medical Center Cleveland Ohio
United States Greenville Hospital System Greenville South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Pain Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm.
Scale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable".
Discharge, Month 1, Month 6, Month 12 No
Primary Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events One year Yes
Secondary Quality of Life Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life.
The Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Pre-op, Month 1, Month 6, 1 year No
Secondary Hernia Recurrence Discharge, 1 Month, 6 Month, 1 year No
See also
  Status Clinical Trial Phase
Completed NCT02975401 - Robotic Utility for Surgical Treatment of Groin Hernias N/A
Completed NCT01421602 - A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia
Recruiting NCT01830452 - Less Chronic Pain After Lichtenstein Hernioplasty Using the Self-gripping Parietex Progrip Mesh Phase 4
Completed NCT00130091 - The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children Phase 2
Completed NCT03665883 - Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia N/A
Recruiting NCT03041948 - Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair N/A
Completed NCT02751190 - Chronic Pain After Groin Hernia Repair N/A
Completed NCT04228536 - Chronic Pain After Groin Hernia Surgery in Women
Completed NCT04839848 - Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty
Recruiting NCT02011698 - Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial N/A
Completed NCT00827944 - Parietex Progrip Study Phase 4
Recruiting NCT03673163 - Lidocaine Infusion for Pain After Herniotomy N/A
Terminated NCT00735124 - Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy Phase 2/Phase 3
Recruiting NCT05323552 - Hernia Repair Using the Totally ExtraPeritoneal (TEP) Laparoscopic Approach Without Curare and Without Orotracheal Intubation.
Completed NCT02616406 - Objective Measure of Recovery After Outpatient Surgery
Completed NCT03326700 - Effects of Hernia Repair on Men's Sexual Functions N/A
Recruiting NCT05839587 - Transabdominal Preperitoneal Inguinal Hernia Repair N/A
Completed NCT03392636 - Comparison of Recurrence Rate of 2 Herniotomy Techniques in Children Older Than 2 Years N/A
Completed NCT05600296 - Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block Phase 1
Recruiting NCT05280860 - Effect of Bilateral RSB on Postoperative Delirium in Elderly Patients Undergoing Laparoendoscopic Single-site Surgery N/A