Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty

NCT04839848 | Completed

• 1 other identifier: Bengan V
• Study Type: observational
• Target: 80,733
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

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

Keywords

Swedish Hernia Registry; Lichtenstein; Surgical mesh; Surgical sutures

Outcome Measures

Primary Outcomes (1)

• CPIP

  Chronic postoperative inguinal pain

  1 year

Study Arms (5)

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

Lichtenstein mesh repair DEVICE

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

Fibrin glue; Long-term absorbable; Permanent suture; Progrip; Short-term absorbable

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All Lichtenstein and similar open mesh repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Uppsala University: collaborator
• Swedish Hernia Registry: collaborator

Related Publications (5)

• 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.

  PMID: 21242440 BACKGROUND

• 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.

  PMID: 16424986 BACKGROUND

• 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.

  PMID: 18161900 BACKGROUND

• 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.

  PMID: 30478683 BACKGROUND

• 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.

  PMID: 35213495 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Femoral; Pain, Postoperative; Chronic Pain

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, SSOD

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: September 1, 2012
• Primary Completion: November 6, 2019
• Study Completion: November 6, 2020
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share