Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery

Recurrence Clinical Trial

Official title:

Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755219
• Other study ID #: Bengan III
• Status: Completed
• Start date: January 1, 2005
• Est. completion date: December 31, 2018

Study information

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

Clinical Trial Summary

The study attempts to quantify the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type. 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 more than 38,000 TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enables assessment of the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type, with fulfilling statistical power. Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. Reoperations were registered in the SHR in the same manner as index repairs, and were used as endpoints.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38450
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• All laparoscopic (mainly TEP and TAPP) repairs that have been registered in the SHR from January 1, 2005 until December 31, 2018.

Exclusion Criteria:

• Open repairs.
• Hernioplasties that were converted from laparoscopic to open surgery.
• Age < 15 years.
• Patients not having a 10-digit state-assigned Patient Identification Number.

Related Conditions & MeSH terms

• Fixation Device; Complications
• Hernia
• Hernia, Femoral
• Hernia, Inguinal
• Laparoscopy
• Recurrence
• Surgical Mesh
• Surgical Procedures, Minimally Invasive
• Surgical Staplers

Intervention

Procedure:
• TEP
By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device
• TAPP
By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Bengt Novik	Skaraborg Hospital Research & Development Center, Sweden, Swedish Hernia Registry, Uppsala University

References & Publications (4)

Novik B, et al. Mesh and mesh fixation in laparoscopic groin hernia repairs. A study of 25,189 TEP and TAPP in the Swedish Hernia Registry [congress abstract]. Hernia 2019; 23 (Suppl 2):S251-S252. https://doi.org/10.1007/s10029-019-02013-8

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation for recurrence	The date of the recurrent surgery	Assessment at Dec 31, 2018
Primary	Death	The date of death	Assessment at Dec 31, 2018