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

• Sponsor: Akdeniz University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02813057
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 11.1
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hernia, Inguinal	Procedure: Stoppa inguinal hernia repair; Procedure: Total extraperitoneal inguinal hernia repair	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stoppa repair Stoppa inguinal hernia repair	Procedure: Stoppa inguinal hernia repair; Stoppa inguinal hernia repair
Experimental: TEP repair Total extraperitoneal inguinal hernia repair	Procedure: Total extraperitoneal inguinal hernia repair; Total extraperitoneal inguinal hernia repair

Outcome Measures

Primary Outcome Measures

1. Functional loss in lower extremity muscles [postoperative day 3]

   Physical activity parameters (isokinetic and isometric values) of the lower extremity muscular functions were measured with a dynamometer.

Secondary Outcome Measures

1. Duration of hospital stay [From time of admission to time of discharge an approximate length of three days]

2. Postoperative pain score [Postoperative 12 hour]

   Visual analog score assessment of post operative pain

3. Recurrence rate [Postoperative 4 months]

   Number of patients with recurrence

4. Complications [Postoperative 1 month]

   Complications like infection, seroma, hematoma, abscess, wound healing problems and urinary retension.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Akdeniz University	Antalya		Turkey	07059

Sponsors and Collaborators

• Akdeniz University

Investigators

• Study Director: Ayhan Mesci, Assoc. Prof., Akdeniz University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Akdeniz University
• ClinicalTrials.gov Identifier: NCT02813057
• Other Study ID Numbers: 201203
• First Posted: Jun 24, 2016
• Last Update Posted: Jun 24, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Hernia; Hernia, Inguinal

Study Results

No Results Posted as of Jun 24, 2016