Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty

NCT ID: NCT04839848

Last Updated: 2022-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80733 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-01

Study Completion Date

2020-11-06

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Permanent suture

Mesh fixation with permanent suture

Lichtenstein mesh repair

Intervention Type DEVICE

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

Long-term absorbable

Mesh fixation with long-term absorbable suture

Lichtenstein mesh repair

Intervention Type DEVICE

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

Short-term absorbable

Mesh fixation with short-term absorbable suture

Lichtenstein mesh repair

Intervention Type DEVICE

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

Fibrin glue

Biologic glue/sealant produced from human donor blood

Lichtenstein mesh repair

Intervention Type DEVICE

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

Progrip

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

Lichtenstein mesh repair

Intervention Type DEVICE

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

Interventions

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Lichtenstein mesh repair

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Swedish Hernia Registry

UNKNOWN

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Bengt Novik

MD, SSOD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 21242440 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16424986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18161900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30478683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35213495 (View on PubMed)

Other Identifiers

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Bengan V

Identifier Type: -

Identifier Source: org_study_id

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