Clinical trial NCT03755219: Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery
Official title: Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Inguinal
Surgical Mesh
Laparoscopy
Hernia
Hernia, Femoral
Surgical Procedures, Minimally Invasive
Surgical Staplers
Recurrence
Fixation Device; Complications
Keywords: Totally extraperitoneal
Transabdominal preperitoneal
Fibrin glue
Fibrin sealant
Mesh fixation
Fixation devices
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Swedish Hernia Registry
name: Skaraborg Hospital Research & Development Center, Sweden
First posted: 2018-11-27
Enrollment: 38450
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reoperation for recurrence
timeFrame: Assessment at Dec 31, 2018
measure: Death
timeFrame: Assessment at Dec 31, 2018
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm
name: Bengt Novik
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.