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Hernia

, Volume 14, Issue 3, pp 231–235 | Cite as

Classification and valuation of postoperative complications in a randomized trial of open versus laparoscopic ventral herniorrhaphy

  • H. M. A. Kaafarani
  • K. Hur
  • M. Campasano
  • D. J. Reda
  • K. M. F. Itani
Original Article

Abstract

Purpose

Generic instruments used for the valuation of health states (e.g., EuroQol) often lack sensitivity to notable differences that are relevant to particular diseases or interventions. We developed a valuation methodology specifically for complications following ventral incisional herniorrhaphy (VIH).

Methods

Between 2004 and 2006, 146 patients were prospectively randomized to undergo laparoscopic (n = 73) or open (n = 73) VIH. The primary outcome of the trial was complications at 8 weeks. A three-step methodology was used to assign severity weights to complications. First, each complication was graded using the Clavien classification. Second, five reviewers were asked to independently and directly rate their perception of the severity of each class using a non-categorized visual analog scale. Zero represented an uncomplicated postoperative course, while 100 represented postoperative death. Third, the median, lowest, and highest values assigned to each class of complications were used to derive weighted complication scores for open and laparoscopic VIH.

Results

Open VIH had more complications than laparoscopic VIH (47.9 vs. 31.5%, respectively; P = 0.026). However, complications of laparoscopic VIH were more severe than those of open VIH. Non-parametric analysis revealed a statistically higher weighted complication score for open VIH (interquartile range: 0–20 for open vs. 0–10 for laparoscopic; P = 0.049). In the sensitivity analysis, similar results were obtained using the median, highest, and lowest weights.

Conclusion

We describe a new methodology for the valuation of complications following VIH that allows a direct outcome comparison of procedures with different complication profiles. Further testing of the validity, reliability, and generalizability of this method is warranted.

Keywords

Hernia Ventral Randomized controlled trial Postoperative complications Classification Valuation 

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Copyright information

© US Government 2010

Authors and Affiliations

  • H. M. A. Kaafarani
    • 1
    • 2
    • 3
  • K. Hur
    • 4
  • M. Campasano
    • 1
  • D. J. Reda
    • 4
  • K. M. F. Itani
    • 1
    • 5
    • 6
  1. 1.Department of SurgeryVA Boston Healthcare System (112)West RoxburyUSA
  2. 2.Center for Health QualityOutcomes and Economic ResearchBedfordUSA
  3. 3.Department of SurgeryTufts Medical CenterBostonUSA
  4. 4.VA Cooperative Studies Program Coordinating CenterHinesUSA
  5. 5.Boston University School of MedicineBostonUSA
  6. 6.Harvard Medical SchoolBostonUSA

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