Clinical Trial: Study of Laparoscopic Inguinal Hernia Repair

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective, Randomized and Controlled Study Comparing Fixation Versus no Fixation of Mesh in Laparoscopic Inguinal Hernia Repair

Brief Summary: Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.

Detailed Summary: A randomized prospective study was conducted. Four groups of patients were constituted: (1) TEP with mesh fixation (2) TEP without fixation, (3) TAPP with mesh fixation, (4) TAPP without fixation. 120 patients were randomized to each group. The principal outcomes assessed were postoperative chronic groin pain assessed by visual analogue pain scale (VAS), hernia recurrence, other morbidity rates and hospital costs. Patients were reviewed in outpatient unit at 1 week and at 1, 6, 12 and 24 months.
Sponsor: Medical Park Gaziantep Hospital

Current Primary Outcome:

• Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS) [ Time Frame: preoperative and postoperative 2nd year ]
  neuralgia, inguinal
• Change from preoperative pain levels at 1 year assessed by the VAS [ Time Frame: preoperative and postoperative 1st year ]
  neuralgia, inguinal
• Change from preoperative pain levels at 6 months assessed by the VAS [ Time Frame: preoperative and postoperative 6th month ]
  neuralgia, inguinal
• Change from preoperative pain levels at 3 months assessed by the VAS [ Time Frame: preoperative and postoperative 3th month ]
  neuralgia, inguinal
• Change from preoperative pain levels at 1 month assessed by the VAS [ Time Frame: preoperative and postoperative 1 month ]
  neuralgia, inguinal
• Change from preoperative pain levels at 1 week assessed by the VAS [ Time Frame: preoperative and postoperative 1th week ]
  neuralgia, inguinal

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Total hospital costs [ Time Frame: up to 24 months ]
  consisted all costs of hospital stays and outpatient treatments
• conversion rate [ Time Frame: through the first day ]
  conversion to open surgery
• recurrence rate [ Time Frame: up to 24 months ]
  clinical and radiological diagnosed
• rate of minor and major complications [ Time Frame: 2 year ]
  it was assessed as; no complication, minor complications, major complications and complications needed reoperation

Original Secondary Outcome: Same as current

Information By: Medical Park Gaziantep Hospital

Dates:
Date Received: September 22, 2016
Date Started: May 2010
Date Completion:
Last Updated: September 29, 2016
Last Verified: September 2016