Chronic Postoperative Pain After Laparoscopic Groin Hernia Repair

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04838028
• Other study ID #: Bengan IV
• Status: Completed
• Start date: September 1, 2012
• Est. completion date: November 6, 2020

Study information

• Verified date: November 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24680
• Est. completion date: November 6, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

All laparoscopic TEP and TAPP repairs 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.

• Previous hernioplasty in the same groin

• 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.

Related Conditions & MeSH terms

• Chronic Pain
• Hernia
• Hernia, Inguinal
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• TEP
Laparoscopic totally extraperitoneal mesh repair of groin hernia
• TAPP
Laparoscopic transabdominal mesh repair of groin hernia

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Swedish Hernia Registry, Uppsala University

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative risk for postoperative pain at 1 year	Chronic postoperative inguinal pain, measured by the Short Form Inguinal Pain Questionnaire (sf-IPQ)	1 year
Secondary	Reoperation	Reoperation due to recurrence, during the study period	1-8 years