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A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy

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International Journal of Colorectal Disease Aims and scope Submit manuscript

Abstract

Purpose

Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT (ClinicalTrials.gov NCT01240772) according to the type of devices used.

Methods

In the DGHAL arm (N = 193), the procedure was done with transanal hemorrhoidal dearterialization (THD)™ (THD, Correggio, Italy) (104 patients) and with HAL-RAR™ (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm (N = 184), procedure for prolapse and hemorrhoids (PPH)-03™ (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)™ (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected.

Results

Three hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group (p < 0.0001); at 90 POD, the overall morbidity was similar between the two groups. In the CSH arm, donut sizes were similar; at 90 POD, the PPH group had a higher risk of postoperative grade 1 morbidity (anal urgency or incontinence) compared to the HEM group (p = 0.003). At 12 POM, no statistical difference was found between the two groups of each arm in terms of grade III recurrence or reoperation.

Conclusion

Postoperative morbidity and outcome at 1 year were similar regardless of the type of devices used. These findings suggest that device type has little impact on HD treatment results.

Trial registration

clinicaltrials.gov—Identifier NCT01240772

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Acknowledgements

The authors are grateful to the “Direction de la recherche clinique,” University Hospital of Nantes: C Dert, V Wyart, C Kubis, and M Treuil-Peraldi for the data acquisition, maintenance of the database, support for data analysis, and layout of figures and J-B Hardouin, PhD (Unit of Methodology and Biostatistics, University Hospital of Nantes, Nantes, France) for the methodological support, statistical analysis, and interpretation. The Safety monitoring committee was led by Dr. L Abramowitz, MD, SNFCP study coordinator.

The authors also thank Andrew Spiers for the editorial review of the manuscript.

LigaLongo Study Group/Participating Investigators having provided and cared for study patients: J-P ARNAUD, C CASA (Service de chirurgie Viscérale, CHU Angers), M-L BARUSSAUD, M COMY (Service de chirurgie viscérale, CHD La Roche/Yon), F BORIE (Hôpital Caremeau, service de Chirurgie digestive, CHU Nîmes), C BOURBAO-TOURNOIS, N HUTEN (Service de chirurgie générale, Hôpital Trousseau, CHU Tours), PA LEHUR, G MEURETTE, H BOUTOILLE, J PODEVIN (Hôtel Dieu, CCDE, CHU Nantes), C BRIGAND, S ROHR (Hôpital de Hautepierre, Chirurgie générale et digestive, CHU Strasbourg), V DE PARADES, A SENEJOUX (Groupe hospitalier Paris Saint-Joseph), A DUBOIS (Service de chirurgie digestive, Hôpital de Vichy), M ELEOUET, F PIGOT (Service de proctologie, Hôpital Bagatelle, Talence), P FARTHOUAT (Polyclinique H. Malartic, Ollioules), J-L FAUCHERON, (Unité de Chirurgie Colorectale, CHU Grenoble), Y GANGNER, (Service de chirurgie digestive, CHD Niort), P GODEBERGE (Institut Mutualiste Montsouris, Paris), X LESAGE, Ph ZERBIB (Hôpital Claude Huriez, CHU Lille), P ORSONI (Service de chirurgie viscérale, AP-HM Hôpital Nord Marseille), R PALAGHIU, J PORCHERON (Service de chirurgie générale digestive, CHU Saint-Étienne), G PORTIER, M QUERALTO (Service de chirurgie digestive, Hôpital Purpan, CHU Toulouse), Y REDON (Service de Chirurgie Digestive, Pôle Hospitalier Mutualiste St Nazaire), I SIELEZNEFF (Service de chirurgie digestive et générale, La Timone, CHU Marseille), L SIPROUDHIS (SMAD, Pontchaillou, CHU Rennes), A-L TARRERIAS (Hôpital Foch, Paris), B VINSON-BONNET (Service de chirurgie viscérale, CH Poissy /Saint-Germain en Laye).

Contributions

Aurelien Venara: data collection, analysis, and interpretation. Manuscript author, provided a critical review of the manuscript and drafted the article. Final approval of the version to be published.

Juliette Podevin: provided care for study patients, provided a critical review of the manuscript, drafted the article, and revised it for important intellectual content. Final approval of the version to be published.

Philippe Godeberge: provided care for study patients, provided a critical review of the manuscript, drafted the article, and revised it for important intellectual content. Final approval of the version to be published.

Yann Redon: provided care for study patients, provided a critical review of the manuscript, drafted the article, and revised it for important intellectual content. Final approval of the version to be published.

Marie-Line Barussaud: provided care for study patients, provided a critical review of the manuscript, drafted the article, and revised it for important intellectual content. Final approval of the version to be published.

Igor Sielezneff: provided care for study patients, provided a critical review of the manuscript, drafted the article, and revised it for important intellectual content. Final approval of the version to be published.

Michel Queralto: provided care for study patients, provided a critical review of the manuscript, drafted the article, and revised it for important intellectual content. Final approval of the version to be published.

Celine Bourbao: provided care for study patients, provided a critical review of the manuscript, drafted the article, and revised it for important intellectual content. Final approval of the version to be published.

Anne Chiffoleau: Qualified Person Responsible for Pharmacovigilance (QPPV) in the trial. Provided a critical review of the manuscript. Final approval of the version to be published.

Paul A Lehur: conception, design, analysis and interpretation of data, manuscript author, provided a critical review of the manuscript, drafted the article, and revised it for important intellectual content. Final approval of the version to be published.

Sources of funding

This study was financed by a grant from the French Ministry of Health (PSTIC, 2010). The sponsor had no role in the study. The study was endorsed by the “Société Nationale Française de Colo-Proctologie” (SNFCP) and the “Société Française de Chirurgie Digestive” (SFCD). Direction Générale de l’Offre de Soins (DGOS)—Ministry of Health, France.

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Authors and Affiliations

  1. Colorectal Unit, Institut des Maladies de l’Appareil Digestif (IMAD), University Hospital of Nantes, Nantes, France

    Aurelien Venara, Juliette Podevin & Paul A Lehur

  2. Department of Digestive Surgery, Angers University Hospital, Angers, France

    Aurelien Venara

  3. Proctology, Institut Mutualiste Montsouris, Paris, France

    Philippe Godeberge

  4. Department of Digestive Surgery, Pôle Hospitalier Mutualiste, St Nazaire, France

    Yann Redon

  5. Department of Visceral Surgery, CHD, La Roche/Yon, France

    Marie-Line Barussaud

  6. Department of General and Digestive Surgery, La Timone University Hospital, Marseilles, France

    Igor Sielezneff

  7. Proctology - Department of Digestive Surgery, University Hospital of Toulouse, Toulouse, France

    Michel Queralto

  8. Department of Digestive Surgery, University Hospital of Tours, Tours, France

    Cecile Bourbao

  9. Office of Research, University Hospital of Nantes, Nantes, France

    Anne Chiffoleau

  10. Department of Digestive and Endocrine Surgery, University Hospital of Nantes, Nantes, France

    Paul A Lehur

Authors
  1. Aurelien Venara
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  2. Juliette Podevin
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  3. Philippe Godeberge
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on behalf of the LigaLongo Study Group

Corresponding author

Correspondence to Paul A Lehur.

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The authors declare that they have no conflict of interest.

Additional information

Podium presentation at the 2017 ASCRS—Tripartite meeting. Seattle (USA), June 2017.

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Venara, A., Podevin, J., Godeberge, P. et al. A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy. Int J Colorectal Dis 33, 1479–1483 (2018). https://doi.org/10.1007/s00384-018-3093-8

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