Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery

Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study

The study attempts to quantify the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type.

For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR).

Study Overview

• Status: Completed
• Conditions: Recurrence; Hernia; Hernia, Inguinal; Laparoscopy; Hernia, Femoral; Surgical Mesh; Fixation Device; Complications; Surgical Procedures, Minimally Invasive; Surgical Staplers
• Intervention / Treatment: Procedure: TEP; Procedure: TAPP

Detailed Description

This is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in the Swedish Hernia Registry (SHR), which covers > 95% of all groin hernia repairs in Sweden. The very large cohort of more than 38,000 TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enables assessment of the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type, with fulfilling statistical power.

Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. Reoperations were registered in the SHR in the same manner as index repairs, and were used as endpoints.

• Study Type: Observational
• Enrollment (Actual): 38450

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of all laparoscopic TEP and TAPP repairs that have been registered in the SHR from September 1, 2005 until December 31, 2017.

The database is the SHR, which was launched in 1992 and prospectively records groin (lateral, medial and femoral) hernia repairs, including both public and private hospitals.

The source population are all residents in Sweden from the age of 15 years, having a state-assigned personal identity number.

Description

Inclusion Criteria:

• All laparoscopic (mainly TEP and TAPP) repairs that have been registered in the SHR from January 1, 2005 until December 31, 2018.

Exclusion Criteria:

• Open repairs.
• Hernioplasties that were converted from laparoscopic to open surgery.
• Age < 15 years.
• Patients not having a 10-digit state-assigned Patient Identification Number.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
StdPPM; Standard pure polypropylene mesh. "Standard" is defined in SHR by weight ≥ 50 g/square meter.	Procedure: TEP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic totally extraperitoneal mesh repair; Procedure: TAPP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic transabdominal preperitoneal mesh repair
LWM; Lightweight mesh: Either a pure polypropylene mesh, or a polypropylene-based composite mesh. The study uses SHR's classification of "light-weight" = <50 g/square meter.	Procedure: TEP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic totally extraperitoneal mesh repair; Procedure: TAPP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic transabdominal preperitoneal mesh repair
Tacks, metal; Metal staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.	Procedure: TEP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic totally extraperitoneal mesh repair; Procedure: TAPP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic transabdominal preperitoneal mesh repair
Tacks, absorbable; Absorbable synthetic staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.	Procedure: TEP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic totally extraperitoneal mesh repair; Procedure: TAPP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic transabdominal preperitoneal mesh repair
Tacks, uncategorized; Staples or tacks were in SHR 2005-2011 not further categorized. This category also includes staples/tacks registered from 2012 and forth, not being specified as either metal or absorbable.	Procedure: TEP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic totally extraperitoneal mesh repair; Procedure: TAPP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic transabdominal preperitoneal mesh repair
Fibrin glue; Biologic glue/sealant produced from human donor blood	Procedure: TEP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic totally extraperitoneal mesh repair; Procedure: TAPP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic transabdominal preperitoneal mesh repair
Non-fixation; Mesh is deployed without fixation	Procedure: TEP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic totally extraperitoneal mesh repair; Procedure: TAPP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic transabdominal preperitoneal mesh repair
3D Mesh; Mesh categorized by anatomical shaped, rather than material or weight. Therefore, this category will be excluded in the original study. Depending on the volume of casess found, the 3D mesh category may eventually be analyzed separately in another study..	Procedure: TEP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic totally extraperitoneal mesh repair; Procedure: TAPP; By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device; Other Names: Laparoscopic transabdominal preperitoneal mesh repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation for recurrence	The date of the recurrent surgery	Assessment at Dec 31, 2018
Death	The date of death	Assessment at Dec 31, 2018

Collaborators and Investigators

• Sponsor: Bengt Novik
• Collaborators: Uppsala University; Swedish Hernia Registry; Skaraborg Hospital Research & Development Center, Sweden
• Investigators: Principal Investigator: Bengt Novik, Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm

Publications and helpful links

General Publications

• Novik B, Nordin P, Skullman S, Dalenback J, Enochsson L. More recurrences after hernia mesh fixation with short-term absorbable sutures: A registry study of 82 015 Lichtenstein repairs. Arch Surg. 2011 Jan;146(1):12-7. doi: 10.1001/archsurg.2010.302.
• Novik B, Hagedorn S, Mork UB, Dahlin K, Skullman S, Dalenback J. Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair: a study with a 40-month prospective follow-up period. Surg Endosc. 2006 Mar;20(3):462-7. doi: 10.1007/s00464-005-0391-3. Epub 2006 Jan 19. Erratum In: Surg Endosc. 2022 May;36(5):3675.
• Novik B, et al. Mesh and mesh fixation in laparoscopic groin hernia repairs. A study of 25,189 TEP and TAPP in the Swedish Hernia Registry [congress abstract]. Hernia 2019; 23 (Suppl 2):S251-S252. https://doi.org/10.1007/s10029-019-02013-8
• Novik B, Sandblom G, Ansorge C, Thorell A. Association of Mesh and Fixation Options with Reoperation Risk after Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study of 25,190 Totally Extraperitoneal and Transabdominal Preperitoneal Repairs. J Am Coll Surg. 2022 Mar 1;234(3):311-325. doi: 10.1097/XCS.0000000000000060.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2005
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Fibrin glue; Mesh fixation; Totally extraperitoneal; Transabdominal preperitoneal; Fibrin sealant; Fixation devices
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Recurrence; Hernia, Femoral
• Other Study ID Numbers: Bengan III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No