Clinical trial NCT04838028: Chronic Postoperative Pain After Laparoscopic Groin Hernia Repair
Official title: Mesh and Fixation Combinations in Laparoscopic Groin Hernia Repair: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Chronic Pain
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Uppsala University
name: Swedish Hernia Registry
First posted: 2021-04-08
Enrollment: 24680
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) depending on different combinations of mesh and mesh fixation. 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 approximately 25,000 primary TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enable assessment of the relative risks for CPIP depending on different combinations of mesh and mesh fixation. Each participant was entered at the date of surgery when demographic and intraoperative data were registered. The possible presence of CPIP after 1 year postoperative was evaluated with a PROM questionnaire.

Eligibility criteria: Inclusion Criteria:

All laparoscopic TEP and TAPP repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018.

Exclusion Criteria:

* Open repairs.
* Hernioplasties that were converted from laparoscopic to open surgery.
* Previous hernioplasty in the same groin
* Surgery merely for hernia (eg obturator) other than lateral, medial or femoral.
* Age \< 15 years.
* Patients not having a 10-digit state-assigned Patient Identification Number.

Primary outcomes:
measure: Relative risk for postoperative pain at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Reoperation
timeFrame: 1-8 years
Other outcomes:
Locations:
Study officials:
affiliation: Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm
name: Bengt Novik, MD
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: 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.