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Efficacy and safety of a resorbable collagen membrane COVA+™ for the prevention of postoperative adhesions in abdominal surgery

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Abstract

Background

This clinical study was designed to assess the efficacy and safety of COVA+™, a collagen membrane (CM), for the prevention of postoperative adhesions in abdominal surgery.

Methods

This prospective multicenter study concerned one hundred and thirteen patients undergoing two-stage abdominal surgeries between 2011 and 2014: either bariatric surgery (BS) or reversal of a diverting stoma (DS). They were divided into two groups, according to whether a CM was placed at the end of the first procedure or not. The primary endpoint was the evaluation of adhesions (incidence, severity, and extent) on the operative site during the second surgery using standard grading scales and a combined adhesion score. Secondary endpoints were the duration of reoperation and the overall postoperative morbidity.

Results

Sixty-five patients were included in the BS group, and forty-eight patients in the DS group. Mean time interval between surgeries was 33.2 ± 51.1 weeks for BS and 14.1 ± 10 weeks for DS. In both indications, results in the CM group were better compared to the control group regarding incidence, severity, and extent of adhesions. Mean combined adhesion scores were lower in the CM group: respectively, 2.1 ± 1.6 versus 3.6 ± 1.7 (p < 0.001) for BS and 1.1 ± 1.7 versus 3.1 ± 2.2 (p < 0.005) for DS. In BS group, the operative duration at reoperation was significantly shorter if a CM was used: 56 ± 34 versus 77 ± 47 min (p < 0.03). No adverse events related to the use of the CM were observed. Overall complication rate was 13.5 % in the CM group versus 27.9 % in the control group. Ease of handling and application of the CM were rated as satisfying or very satisfying in the great majority of cases.

Conclusions

In abdominal surgery, COVA+™ acts efficiently on the prevention of postoperative adhesions with lower incidence, severity, and extent levels. The CM can be used safely and might render reoperations less difficult.

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Acknowledgments

We would like to thank Dr. P. Hauters (Centre Hospitalier Wallonie Picardie, Tournai, Belgium) for the conduct of statistical analyses. The following study investigators are acknowledged for enrollment and follow-up of patients: Drs. G. Fromont (Polyclinique du Bois Bernard, Bois Bernard, France), T. Barthes (Polyclinique de Poitiers, Poitiers, France), J-H. Longeville (Polyclinique du Val de Loire, Nevers, France), B. Bokobza (Hôpital J. Monot, Le Havre, France), T. Dugué (Clinique de Saint-Omer, Blendecques, France), A. Valverde (Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France), S. Auvray (Centre Hospitalier Privé Saint-Martin, Caen, France), P. Malvaux (CH WAPI site Notre Dame, Tournai, Belgium), E. Olagne (Clinique du Tonkin, Villeurbanne, France), E. Magne (Clinique Tivoli, Bordeaux, France), P. Ledaguenel (Clinique Tivoli, Bordeaux, France).

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Authors and Affiliations

  1. Visceral and Digestive Surgery, Clinique de Saint-Omer, Blendecques, France

    André Dabrowski & Club Coelio

  2. General and Digestive Surgery, Clinique Saint-Charles, 11 Boulevard René Lévesque, 85000, La Roche-Sur-Yon, France

    Marc Lepère & Club Coelio

  3. Visceral and Digestive Surgery, Clinique du Mail, La Rochelle, France

    Constantin Zaranis & Club Coelio

  4. General, Digestive, Laparoscopic and Endocrine Surgery, CH WAPI, Site Notre Dame, Tournai, Belgium

    Club Coelio & Philippe Hauters

Authors
  1. André Dabrowski
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  2. Marc Lepère
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  3. Constantin Zaranis
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Corresponding author

Correspondence to Marc Lepère.

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Disclosures

As president of the Club Coelio and organizer of the Club Coelio Congress, Constantin ZARANIS has financial partnerships with a number of companies. However, he received no personal funding for this study. The Club Coelio is an independent scientific institution whose objective is to assess the use of different procedures and prostheses for laparoscopic procedure. It therefore has relationships with a number of companies with an interest in independent evaluation of their products. Drs. Dabrowski, Lepère, Zaranis, and Hauters have no conflicts of interest or financial ties to disclose.

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Dabrowski, A., Lepère, M., Zaranis, C. et al. Efficacy and safety of a resorbable collagen membrane COVA+™ for the prevention of postoperative adhesions in abdominal surgery. Surg Endosc 30, 2358–2366 (2016). https://doi.org/10.1007/s00464-015-4484-3

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