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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01778387
First Posted: January 29, 2013
Last Update Posted: January 29, 2013
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.
Information provided by (Responsible Party):
Rafael Balongo-Garcia, Fundación Andaluza Beturia para la Investigación en Salud
  Purpose
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 Intervention Phase
Hernia, Ventral Procedure: Laparoscopic ventral hernia repair Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rafael Balongo-Garcia, Fundación Andaluza Beturia para la Investigación en Salud:

Primary Outcome Measures:
  • 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.


Enrollment: 130
Study Start Date: January 2005
Study Completion Date: December 2012
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01778387


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

Responsible Party: Rafael Balongo-Garcia, General and Gastrointestinal Surgery, Fundación Andaluza Beturia para la Investigación en Salud
ClinicalTrials.gov Identifier: NCT01778387     History of Changes
Other Study ID Numbers: ECUHV
First Submitted: January 24, 2013
First Posted: January 29, 2013
Last Update Posted: January 29, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal