CClinicalTrials.gg
CompletedNCT04839848Updated Dec 5, 2022

Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty

An observational study in Hernia, Inguinal, Hernia, Femoral and Postoperative Pain, sponsored by Karolinska Institutet. Completed. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2022-12-05.

Sponsored by Karolinska Institutet · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80,733
Ages
15 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Hernia, Inguinal
  • Hernia, Femoral
  • Postoperative Pain
  • Chronic Pain
  • PROM
  • Suture Related Complication

Keywords

  • Swedish Hernia Registry
  • Lichtenstein
  • Surgical mesh
  • Surgical sutures
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's enrollment of 80,733 is above the median of 102 across 607 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

An unselected, consecutive nationwide cohort during 7 years, with a 1-year follow-up

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

Exclusion Criteria:

  • Laparoscopic repairs.
  • Preperitoneal open repairs.
  • Pure suture repairs
  • Patients not having a 10-digit state-assigned Patient Identification Number.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80,733 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Permanent suture

    Mesh fixation with permanent suture

    Device: Lichtenstein mesh repair

  • Long-term absorbable

    Mesh fixation with long-term absorbable suture

    Device: Lichtenstein mesh repair

  • Short-term absorbable

    Mesh fixation with short-term absorbable suture

    Device: Lichtenstein mesh repair

  • Fibrin glue

    Biologic glue/sealant produced from human donor blood

    Device: Lichtenstein mesh repair

  • Progrip

    Pre-fabricated absorbable fixation hooks, integrated in mesh. Progrip is a registered trademark owned by Medtronic

    Device: Lichtenstein mesh repair

Interventions

  • DeviceLichtenstein mesh repair

    A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures

06

What researchers measure

Primary outcomes

  1. CPIP

    Chronic postoperative inguinal pain

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 21242440 ↗
  • 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. Erratum In: Surg Endosc. 2022 May;36(5):3675. doi: 10.1007/s00464-022-09196-9. PubMed 16424986 ↗
  • 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. PubMed 18161900 ↗
  • 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. PubMed 30478683 ↗
  • 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. PubMed 35213495 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04839848
Lead sponsor
Karolinska Institutet
Collaborators
Uppsala University, Swedish Hernia Registry
Responsible party
Bengt Novik (MD, SSOD, Karolinska Institutet) — Principal investigator
First posted
Apr 9, 2021
Start date
Sep 1, 2012
Primary completion
Nov 6, 2019
Completion
Nov 6, 2020
Last update
Dec 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion