Recurrence Clinical Trial
Official title:
Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study
Verified date | November 2022 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bengt Novik | Skaraborg Hospital Research & Development Center, Sweden, Swedish Hernia Registry, Uppsala University |
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
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 |
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