Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results

Unilateral Inguinal Hernia With Gangrene and Obstruction Clinical Trial

Official title:

Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561910
• Other study ID #: HerniaCR
• Status: Completed
• Phase: N/A
• First received: September 25, 2015
• Last updated: September 25, 2015
• Start date: January 2000
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Hernia Center Rottenburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one year period a total of 1208 inguinal hernias in 952 patients were consecutively operated using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine.

Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the standard procedure in inguinal hernia repair in future.

Description:

Objective:

Hernia repair is the most frequent operation in general surgery worldwide, but about 25 years after the advent of minimal invasive surgical techniques the effectiveness of laparoscopic inguinal hernia repair still remains unclear.

Methods:

All patients admitted to the hospital for surgery of an inguinal hernia during a one year period were prospectively documented and included in a follow-up study. The follow-up was performed at least 5 years after surgery and consisted of a clinical examination, ultrasound investigation and a questionnaire.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 952
• Est. completion date: August 2015
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• All patients fit for general anesthesia and presenting an inguinal hernia.

Exclusion Criteria:

• Not fit for general anesthesia, young age (>21 years), not wanting a mesh.

Related Conditions & MeSH terms

• Gangrene
• Hernia
• Hernia, Inguinal
• Unilateral Inguinal Hernia With Gangrene and Obstruction

Intervention

Device:
• Laparoscopic hernia repair
Preperitoneal mesh implantation because of inguinal hernia disease using the laparoscopic technique

Locations

Country	Name	City	State
Germany	Hernia Center	Rottenburg

Sponsors (1)

Lead Sponsor	Collaborator
Hernia Center Rottenburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Cavazzola LT, Rosen MJ. Laparoscopic versus open inguinal hernia repair. Surg Clin North Am. 2013 Oct;93(5):1269-79. doi: 10.1016/j.suc.2013.06.013. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome of the trial was recurrence of a hernia within five years after the repair.		5 years
Secondary	The secondary outcome was chronic pain.	Chronic pain was measured by VAS scale	5 years