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OpenTrials
Completed

NCT Number: NCT04838028

Chronic Postoperative Pain After Laparoendoscopic Groin Hernia Repair

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).

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Key information

Conditions

Postoperative Pain Chronic Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEP

Procedure

Laparoendoscopic totally extraperitoneal mesh repair of groin hernia

TAPP

Procedure

Laparoscopic transabdominal mesh repair of groin hernia

Other or unspecified laparoendoscopic groin hernia repair

Procedure

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

Primary outcomes

  1. Relative risk for postoperative pain at 1 year

    Time frame: 1 year

    Chronic postoperative inguinal pain, measured by the Short Form Inguinal Pain Questionnaire (sf-IPQ)

Secondary outcomes

  1. Reoperation

    Time frame: 1-8 years

    Reoperation due to recurrence, during the study period

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Swedish Hernia Registry
  • Uppsala University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2020
First posted
Apr 8, 2021
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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