Impacts of Stoppa and Total Extraperitoneal Inguinal Hernia Repair on the Lower Extremity Muscular Functions

Hernia, Inguinal Clinical Trial

Official title:

Quantitative Assessment of the Impacts of Stoppa Repair and Total Extraperitoneal Repair on the Lower Extremity Muscular Functions in Cases of Unilateral Inguinal Hernia; a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813057
• Other study ID #: 201203
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: June 22, 2016
• Start date: March 2012
• Est. completion date: February 2013

Study information

• Verified date: June 2016
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Comparison of physical activity parameters of the lower extremity muscles in patients who received total extraperitoneal repair (TEP) and STOPPA repair.

Description:

The patients were evaluated during the preoperative period and in the postoperative day 3, to achieve an isometric and isokinetic, objective assessment of the pain-related lower extremity muscular function changes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Unilateral inguinal hernia

Exclusion Criteria:

• Contralateral hernia repair history

• Recurrent inguinal hernia

• Incarceration or strangulation

• Bilateral inguinal hernia

• Severe congestive heart failure

• Severe hypertension

• Rheumatoid arthritis

• Systemic or neurologic diseases altering lower extremity functions

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• Stoppa inguinal hernia repair
Stoppa inguinal hernia repair
• Total extraperitoneal inguinal hernia repair
Total extraperitoneal inguinal hernia repair

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional loss in lower extremity muscles	Physical activity parameters (isokinetic and isometric values) of the lower extremity muscular functions were measured with a dynamometer.	postoperative day 3	Yes
Secondary	Duration of hospital stay		From time of admission to time of discharge an approximate length of three days	No
Secondary	Postoperative pain score	Visual analog score assessment of post operative pain	Postoperative 12 hour	No
Secondary	Recurrence rate	Number of patients with recurrence	Postoperative 4 months	No
Secondary	Complications	Complications like infection, seroma, hematoma, abscess, wound healing problems and urinary retension.	Postoperative 1 month	Yes