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Chronic Postoperative Pain After Laparoendoscopic Groin Hernia Repair

Mesh and Fixation Combinations in Laparoendoscopic Groin Hernia Repair: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04838028
Enrollment
15360
Registered
2021-04-08
Start date
2012-09-01
Completion date
2020-11-06
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Postoperative Pain

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.

Interventions

PROCEDURETEP

Laparoendoscopic totally extraperitoneal mesh repair of groin hernia

PROCEDURETAPP

Laparoscopic transabdominal mesh repair of groin hernia

PROCEDUREOther or unspecified laparoendoscopic groin hernia repair

Other refers to any laparoendoscopic mesh repair specified as not being either TEP or TAPP, eg, intraperitoneal onlay mesh (IPOM).

Sponsors

Uppsala University
CollaboratorOTHER
Swedish Hernia Registry
CollaboratorUNKNOWN
Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All laparoendoscopic repairs for groin hernia 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. * Bilateral repairs. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Relative risk for postoperative pain at 1 year1 yearChronic postoperative inguinal pain, measured by the Short Form Inguinal Pain Questionnaire (sf-IPQ)

Secondary

MeasureTime frameDescription
Reoperation1-8 yearsReoperation due to recurrence, during the study period

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026