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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03755219
Other study ID # Bengan III
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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