Cost- Effectiveness and Cost-utility of Laparoscopic Versus Open Repair of Ventral Hernia
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|ClinicalTrials.gov Identifier: NCT01778387|
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : January 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Ventral||Procedure: Laparoscopic ventral hernia repair||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Cost- Effectiveness and Cost-utility of Laparoscopic Versus Open Repair of Ventral Hernia: Randomized Clinical Trial|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2012|
Active Comparator: Laparoscopic ventral hernia repair
Laparoscopic repair: Pneumoperitoneum was performed to 12 mmHg. Herniary contents and sac are reduced releasing adhesions with diathermy or harmonic scalpel. Defects are repaired with a polytetrafluoroethylene (PTFE) patch (Dual Mesh; W.L Gore and Associates, FlagstaV, AZ USA) with double crown fixation as technique of Carbajo et al, ensuring exceed 3 cm edge of defect, using 5mm tackers (Protack, Autosuture; Tyco Healthcare, USA), reducing intrabdominal pressure to 8 mmHg. All operations were performed by experienced surgeons, over than 40 laparoscopic ventral hernia repairs.
Procedure: Laparoscopic ventral hernia repair
Intraperitoneal ventral hernia repair with the use of Gore-tex Patch
Placebo Comparator: Open ventral hernia repair
Open repair: Incision was made over hernia defect, reducing herniary contents by opening sac if it is necessary. We made 4 cm soft tissue flaps around edge of defect depending on available healthy fascial tissue. Chevrel technique with fascial closure using anterior rectus sheath with continuous and absorbable suture and placement of polypropylene mesh (Parietene standart polypropylene mesh, Covidien, Norwalk, CT) in an onlay position fixed with polypropylene suture.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778387
|Hospital Infanta Elena|
|Huelva, Spain, 21005|
|Study Director:||Pedro Naranjo-Rodríguez, Dr||Surgery Dep. Complejo Hospitalario Huelva|