Clinical trial NCT04839848: Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty
Official title: Mesh and Fixation Combinations in the Lichtenstein Groin Hernioplasty: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Inguinal
Hernia, Femoral
Postoperative Pain
Chronic Pain
PROM
Suture Related Complication
Keywords: Swedish Hernia Registry
Lichtenstein
Surgical mesh
Surgical sutures
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Swedish Hernia Registry
First posted: 2021-04-09
Enrollment: 80733
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: An unselected, consecutive nationwide cohort during 7 years, with a 1-year follow-up

Brief summary: The study attempts to quantify the relative risks for chronic postoperative inguinal pain (CPIP) after Lichtenstein repair of groin hernia, depending on mesh type and fixation suture material.

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 SHR, which covers \> 95% of all groin hernia repairs in Sweden. The large database enables assessment of the relative risks for CPIP depending on in particular mesh and mesh fixation, adjusted for other plausible risk factors.

Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. One year postop, each patient was sent a questionnaire focusing on present pain.

Eligibility criteria: Inclusion Criteria:

All Lichtenstein and similar open mesh repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018.

Exclusion Criteria:

* Laparoscopic repairs.
* Preperitoneal open repairs.
* Pure suture repairs
* Patients not having a 10-digit state-assigned Patient Identification Number.

Primary outcomes:
measure: CPIP
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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: Franneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyren O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93. doi: 10.1002/bjs.6014.
citation: Olsson A, Sandblom G, Franneby U, Sonden A, Gunnarsson U, Dahlstrand U. The Short-Form Inguinal Pain Questionnaire (sf-IPQ): An Instrument for Rating Groin Pain After Inguinal Hernia Surgery in Daily Clinical Practice. World J Surg. 2019 Mar;43(3):806-811. doi: 10.1007/s00268-018-4863-8.
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.