Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery
1 other identifier
observational
38,450
0 countries
N/A
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2005
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedFirst Submitted
Initial submission to the registry
November 21, 2018
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedDecember 1, 2022
November 1, 2022
13 years
November 21, 2018
November 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reoperation for recurrence
The date of the recurrent surgery
Assessment at Dec 31, 2018
Death
The date of death
Assessment at Dec 31, 2018
Study Arms (8)
StdPPM
Standard pure polypropylene mesh. "Standard" is defined in SHR by weight ≥ 50 g/square meter.
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.
Tacks, metal
Metal staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.
Tacks, absorbable
Absorbable synthetic staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.
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.
Fibrin glue
Biologic glue/sealant produced from human donor blood
Non-fixation
Mesh is deployed without fixation
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..
Interventions
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
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
Eligibility Criteria
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.
You may qualify if:
- All laparoscopic (mainly TEP and TAPP) repairs that have been registered in the SHR from January 1, 2005 until December 31, 2018.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bengt Noviklead
- Uppsala Universitycollaborator
- Swedish Hernia Registrycollaborator
- Skaraborg Hospital Research & Development Center, Swedencollaborator
Related Publications (4)
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.
PMID: 21242440BACKGROUNDNovik 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.
PMID: 16424986BACKGROUNDNovik 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
RESULTNovik 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.
PMID: 35213495RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bengt Novik
Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 14 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 21, 2018
First Posted
November 27, 2018
Study Start
January 1, 2005
Primary Completion
December 31, 2017
Study Completion
December 31, 2018
Last Updated
December 1, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share