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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rafael Balongo-Garcia, Fundación Andaluza Beturia para la Investigación en Salud
ClinicalTrials.gov Identifier:
NCT01778387
First received: January 24, 2013
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Fundación Andaluza Beturia para la Investigación en Salud:

Primary Outcome Measures:
  • Cost-effectiveness [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 24, 2013
Last Updated: January 25, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on May 16, 2013