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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01778387
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : January 29, 2013
Information provided by (Responsible Party):
Rafael Balongo-Garcia, Fundación Andaluza Beturia para la Investigación en Salud

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

Condition or disease Intervention/treatment Phase
Hernia, Ventral Procedure: Laparoscopic ventral hernia repair Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients above 18 years old, diagnosed
  • Primary or incisional ventral hernia (clinic and radiologic: abdominal wall CT scan), including recurrent ones,
  • Hernia estimated size from 20 to 225 cm2.

Exclusion Criteria:

  • Included type 4 or 5 of ASA (American Society of Anesthesiologist),
  • Disease limiting lifespan to less than 2 years,
  • Cirrhotic ascites,
  • Emergency surgery
  • intestinal obstruction,
  • strangulated hernia,
  • peritonitis,
  • Local or systemic infection,
  • failure of patient to ensure an at least 2 years follow-up or abandonment protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01778387

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Hospital Infanta Elena
Huelva, Spain, 21005
Sponsors and Collaborators
Fundación Andaluza Beturia para la Investigación en Salud
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Study Director: Pedro Naranjo-Rodríguez, Dr Surgery Dep. Complejo Hospitalario Huelva

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Responsible Party: Rafael Balongo-Garcia, General and Gastrointestinal Surgery, Fundación Andaluza Beturia para la Investigación en Salud Identifier: NCT01778387    
Other Study ID Numbers: ECUHV
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal