Comparison of Different Meshes in Laparoscopic Hernia Repair

NCT02712827 | Completed DMC

• 1 other identifier: UW 16-042
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The placement of mesh is important in hernia surgery as it helps to reduce recurrence, yet the method of fixation of mesh may cause pain after surgery. In laparoscopic hernia repair, surgeon uses different methods to fix the mesh in large hernia defects or bilateral inguinal hernias. Progrip is a special mesh developed by manufacturer that it can be self-gripped to tissue, as a result no fixation is required after placement. There are few data about Progrip in laparoscopic hernia repair. In this randomized controlled trial we would like to compare the use of Progrip with the "conventional" mesh in laparoscopic hernia repair. Surgery is performed in the usual manner; prior to placement of mesh, surgeon will get the randomization result for that particular patient: Progrip and non-Progrip group. No fixation is required for Progrip group, while fixation with fibrin glue is needed for non-Progrip group. Intraoperative data (e.g. mesh deployment time, operative time, etc) will be collected. Patients will be assessed in clinic at 2-week, 3-month, 6-month and 1-year interval after surgery. Additional visits may be arranged if considered necessary. At follow up patient will be seen by surgeon first to review the wound condition and to look for any recurrence; while other post-operative data including total analgesic usage (number of tablets), return to normal activities (days), return to work (days), pain score etc will be assessed and recorded by a trained nurse who is blinded to the treatment that patient received. Any hernia recurrence will be recorded and treated accordingly. Primary aim of this study is to look for any difference of the 2 groups in terms of postoperative pain and quality of life scores.

Conditions

Hernia, Inguinal

Keywords

self-gripping mesh, fibrin glue, total extraperitoneal

Outcome Measures

Primary Outcomes (1)

• Chronic pain

  Chronic pain after hernia surgery was defined as the presence of pain at rest at the groin area. The severity of pain will be measured by a linear analogue pain score sacle from 0 to 10. Score \>= 1 indicate the presence of pain.

  3 months post surgery

Secondary Outcomes (4)

• mesh deployment time

  1 day

• intraoperative complications

  1 day

• hernia recurrence rate

  1 year

• quality of life

  1 year

Study Arms (2)

Progrip

EXPERIMENTAL

The Progrip group is the intervention group. Patients will undergo laparoscopic total extraperitoneal repair of inguinal hernia. The surgeon will use a self-gripping mesh to repair the hernia. No fixation is required for the mesh.

Procedure: Progrip

Non-Progrip

ACTIVE COMPARATOR

The Non-Progrip group is the control group. Operation is performed under general anesthesia. A standard three-trocar technique is used: one infra-umbilical camera trocar (1cm) and two 5mm trocars placed at midline between the umbilicus and pubic bone (or one at the side of inguinal hernia). A laparoscope is inserted to the preperitoneal space through the incision. The space is insufflated with carbon dioxide. Dissection is performed, hernia content (if any) is reduced. A non self-gripping synthetic mesh is placed. Fibrin glue is used for fixation.

Procedure: Non-Progrip

Interventions

Progrip PROCEDURE

Self-fixating mesh

Progrip

Non-Progrip PROCEDURE

Non self-fixating mesh with the use of glue

Non-Progrip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18
• Unilateral inguinal hernia with large hernia defect size (\>3cm)
• Bilateral inguinal hernias
• American Society of Anesthesiologists (ASA) score: 1-2
• Provision of written informed consent

You may not qualify if:

• Any prior surgery for ipsilateral inguinal hernia (i.e. recurrent inguinal hernia)
• American Society of Anesthesiologists (ASA) score: 3 or above
• History of major abdominal surgery that may result in difficulty in development of preperitoneal space
• Subject is pregnant or breast feeding
• Any serious concomitant illness with short life expectancy
• Subject who is not able to attend follow up postoperatively

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Tung Wah Hospital

Hong Kong, Hong Kong

Location

Related Publications (13)

• Bresnahan E, Bates A, Wu A, Reiner M, Jacob B. The use of self-gripping (Progrip) mesh during laparoscopic total extraperitoneal (TEP) inguinal hernia repair: a prospective feasibility and long-term outcomes study. Surg Endosc. 2015 Sep;29(9):2690-6. doi: 10.1007/s00464-014-3991-y. Epub 2014 Dec 18.

  PMID: 25519425 BACKGROUND

• Kingsnorth A, Gingell-Littlejohn M, Nienhuijs S, Schule S, Appel P, Ziprin P, Eklund A, Miserez M, Smeds S. Randomized controlled multicenter international clinical trial of self-gripping Parietex ProGrip polyester mesh versus lightweight polypropylene mesh in open inguinal hernia repair: interim results at 3 months. Hernia. 2012 Jun;16(3):287-94. doi: 10.1007/s10029-012-0900-y. Epub 2012 Mar 28.

  PMID: 22453675 BACKGROUND

• Teng YJ, Pan SM, Liu YL, Yang KH, Zhang YC, Tian JH, Han JX. A meta-analysis of randomized controlled trials of fixation versus nonfixation of mesh in laparoscopic total extraperitoneal inguinal hernia repair. Surg Endosc. 2011 Sep;25(9):2849-58. doi: 10.1007/s00464-011-1668-3. Epub 2011 Apr 13.

  PMID: 21487873 BACKGROUND

• Tam KW, Liang HH, Chai CY. Outcomes of staple fixation of mesh versus nonfixation in laparoscopic total extraperitoneal inguinal repair: a meta-analysis of randomized controlled trials. World J Surg. 2010 Dec;34(12):3065-74. doi: 10.1007/s00268-010-0760-5.

  PMID: 20714896 BACKGROUND

• Belyansky I, Tsirline VB, Klima DA, Walters AL, Lincourt AE, Heniford TB. Prospective, comparative study of postoperative quality of life in TEP, TAPP, and modified Lichtenstein repairs. Ann Surg. 2011 Nov;254(5):709-14; discussion 714-5. doi: 10.1097/SLA.0b013e3182359d07.

  PMID: 21997807 BACKGROUND

• Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009 Aug;13(4):343-403. doi: 10.1007/s10029-009-0529-7. Epub 2009 Jul 28.

  PMID: 19636493 BACKGROUND

• Pokorny H, Klingler A, Schmid T, Fortelny R, Hollinsky C, Kawji R, Steiner E, Pernthaler H, Fugger R, Scheyer M. Recurrence and complications after laparoscopic versus open inguinal hernia repair: results of a prospective randomized multicenter trial. Hernia. 2008 Aug;12(4):385-9. doi: 10.1007/s10029-008-0357-1. Epub 2008 Feb 19.

  PMID: 18283518 BACKGROUND

• Myers E, Browne KM, Kavanagh DO, Hurley M. Laparoscopic (TEP) versus Lichtenstein inguinal hernia repair: a comparison of quality-of-life outcomes. World J Surg. 2010 Dec;34(12):3059-64. doi: 10.1007/s00268-010-0730-y.

  PMID: 20703474 BACKGROUND

• Langeveld HR, van't Riet M, Weidema WF, Stassen LP, Steyerberg EW, Lange J, Bonjer HJ, Jeekel J. Total extraperitoneal inguinal hernia repair compared with Lichtenstein (the LEVEL-Trial): a randomized controlled trial. Ann Surg. 2010 May;251(5):819-24. doi: 10.1097/SLA.0b013e3181d96c32.

  PMID: 20395851 BACKGROUND

• Eklund AS, Montgomery AK, Rasmussen IC, Sandbue RP, Bergkvist LA, Rudberg CR. Low recurrence rate after laparoscopic (TEP) and open (Lichtenstein) inguinal hernia repair: a randomized, multicenter trial with 5-year follow-up. Ann Surg. 2009 Jan;249(1):33-8. doi: 10.1097/SLA.0b013e31819255d0.

  PMID: 19106673 BACKGROUND

• Dulucq JL, Wintringer P, Mahajna A. Laparoscopic totally extraperitoneal inguinal hernia repair: lessons learned from 3,100 hernia repairs over 15 years. Surg Endosc. 2009 Mar;23(3):482-6. doi: 10.1007/s00464-008-0118-3. Epub 2008 Sep 23.

  PMID: 18810548 BACKGROUND

• Gong K, Zhang N, Lu Y, Zhu B, Zhang Z, Du D, Zhao X, Jiang H. Comparison of the open tension-free mesh-plug, transabdominal preperitoneal (TAPP), and totally extraperitoneal (TEP) laparoscopic techniques for primary unilateral inguinal hernia repair: a prospective randomized controlled trial. Surg Endosc. 2011 Jan;25(1):234-9. doi: 10.1007/s00464-010-1165-0. Epub 2010 Jun 15.

  PMID: 20552368 BACKGROUND

• Rutkow IM. Demographic and socioeconomic aspects of hernia repair in the United States in 2003. Surg Clin North Am. 2003 Oct;83(5):1045-51, v-vi. doi: 10.1016/S0039-6109(03)00132-4.

  PMID: 14533902 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dominic, Chi Chung Foo, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 18, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)