Clinical Trial: Cost- Effectiveness and Cost-utility of Laparoscopic Versus Open Repair of Ventral Hernia

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

Official Title: Cost- Effectiveness and Cost-utility of Laparoscopic Versus Open Repair of Ventral Hernia: Randomized Clinical Trial

Brief Summary: The purpose of this prospective paper is to make a comparison between laparoscopic and opening approaches in ventral hernia repair, taking into account absence of recurrence in long - time (5 years), results centered at patient, especially satisfaction with expectations and improvement of normal physical activity, morbidity that particular form must include chronic pain, adjusted mortality through co-morbidities and, finally, prospective expenses, related to both effectiveness and utility

Detailed Summary:

Population: 130 patients, diagnosed with clinic and radiologic (abdominal wall CT scan) ventral hernia, were recruited, after expressing their willingness, for either laparoscopic or laparotomy repair to be conducted at Infanta Elena Hospital, Huelva (Spain), between January 2005 and October 2008. Recruitment criteria were: patients above 18 years old, diagnosed with primary or incisional ventral hernia, including recurrent ones, featuring a prior-to-operation estimated size from 20 to 225 cm2. Exclusion criteria included type 4 or 5 of ASA (American Society of Anesthesiologist), to suffer from a disease limiting lifespan to less than 2 years, cirrhotic ascites, emergency surgery or any complication as intestinal obstruction, strangulated hernia, peritonitis, local or systemic infection, failure of patient to ensure an at least 2 years follow-up or abandonment protocol. Every patient was fully informed and signed his willingness. Defect sizes were estimated and classified following Chevrel Classification. Patients were assigned a randomly generated number (see validated and published tables), meaning both laparoscopic or open repair, and informed same morning of operation. All operations were conducted by experienced surgeons. Protocol was approved by Local Ethics Committee.

General techniques

All patients were given an heparin prophylactic dose to prevent thromboembolic events evening prior to operation-day, as well as 1500 mg cefuroxime intravenous (IV) during anesthetic induction (in case of allergy, 600 mg of clindamycin IV + 80 mg of gentamicin IV). Also, evening before intervention-day all patients filled in survey (SF-36 questionnaire). Skin was prepared with an alcoholic solution of clorhexidine. Surgical pain was treated with magnesium metamizole (2gr IV each 6 hours). Upon patient request, 100 mg of tramadol IV w
Sponsor: Fundación Andaluza Beturia para la Investigación en Salud

Current Primary Outcome:

  • Cost-effectiveness [ Time Frame: 5 years ]
    As effectiveness measure a clinic profit analysis was carried out by means of a composite analysis that integrates absence of recurrence, readmission, reoperation or disability.
  • Cost-utility [ Time Frame: 5 years ]
    As an indirect measure of utility is used values obtained from questionnaires (HRQOL -Health Related Quality Of Life), assuming standard mean response in case of SF-36 and mean response standardized by standard deviation of difference in case of CVP-CG instruments between two types of repairs as well as effect size between preoperative value and postoperative one in case of SF-36. choice of measurement of HRQOL as a measure of utility was made under requirement that in absence of clinically relevant differences in mortality, recurrence or morbidity, a clinically relevant difference in HRQOL is a preference by patient and thus a choice between treatment alternatives.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Fundación Andaluza Beturia para la Investigación en Salud

Dates:
Date Received: January 24, 2013
Date Started: January 2005
Date Completion:
Last Updated: January 25, 2013
Last Verified: January 2013