Paul A Lehur1, Anne S Didnée, Jean-Luc Faucheron, Guillaume Meurette, Philippe Zerbib, Laurent Siproudhis, Béatrice Vinson-Bonnet, Anne Dubois, Christine Casa, Jean-Benoit Hardouin, Isabelle Durand-Zaleski. 1. *Colorectal Unit, Institut des Maladies de l'Appareil Digestif (IMAD), University Hospital of Nantes, Nantes, France †Colorectal Unit, Department of Surgery, Michallon University Hospital, Grenoble, France ‡Colorectal Unit, Department of Surgery, University Hospital of Lille, Lille, France §Department of Proctology, University Hospital of Rennes, Rennes, France ¶Department of Digestive Surgery, Poissy Hospital, Saint-Germain en Laye, France ||Department of Digestive Surgery, Vichy Hospital, Vichy, France **Department of Surgery, University Hospital of Angers, Angers, France ††Unit of Methodology and Biostatistics, University Hospital of Nantes, Nantes, France ‡‡Health economics and health policy research unit, AP-HP Paris, France.
Abstract
OBJECTIVE: To compare Doppler-guided hemorrhoidal artery ligation (DGHAL) with circular stapled hemorrhoidopexy (SH) in the treatment of grade II/III hemorrhoidal disease (HD). BACKGROUND:DGHAL is a treatment option for symptomatic HD; existing studies report limited risk and satisfactory outcomes. DGHAL has never before been compared with SH in a large-scale multi-institutional randomized clinical trial. METHODS:Three hundred ninety-three grade II/III HD patients recruited in 22 centers from 2010 to 2013 were randomized toDGHAL (n = 197) or SH (n = 196). The primary endpoint was operative-related morbidity at 3 months (D.90) based on the Clavien-Dindo surgical complications grading. Total cost, cost-effectiveness, and clinical outcome were assessed at 1 year. RESULTS: At D.90, operative-related adverse events occurred after DGHAL and SH, respectively, in 47 (24%) and 50 (26%) patients (P = 0.70). DGHAL resulted in longer mean operating time (44±16 vs 30±14 min; P < 0.001), less pain (postoperative and at 2 wks visual analogic scale: 2.2 vs 2.8; 1.3 vs 1.9; P = 0.03; P = 0.013) and shorter sick leave (12.3 vs 14.8 d; P = 0.045). At 1 year, DGHAL led to more residual grade III HD (15% vs 5%) and a higher reoperation rate (8% vs 4%). Patient satisfaction was >90% for both procedures. Total cost at 1 year was greater for DGHAL [&OV0556;2806 (&OV0556;2670; 2967) vs &OV0556;2538 (&OV0556;2386; 2737)]. The D.90, incremental cost-effectiveness ratio (ICER) was &OV0556;7192 per averted complication. At 1 year DGHAL strategy was dominated. CONCLUSIONS:DGHAL and SH are viable options in grade II/III HD with no significant difference in operative-related risk. Although resulting in less postoperative pain and shorter sick leave, DGHAL was more expensive, took longer, and provided a possible inferior anatomical correction suggesting an increased risk of recurrence.
RCT Entities:
OBJECTIVE: To compare Doppler-guided hemorrhoidal artery ligation (DGHAL) with circular stapled hemorrhoidopexy (SH) in the treatment of grade II/III hemorrhoidal disease (HD). BACKGROUND: DGHAL is a treatment option for symptomatic HD; existing studies report limited risk and satisfactory outcomes. DGHAL has never before been compared with SH in a large-scale multi-institutional randomized clinical trial. METHODS: Three hundred ninety-three grade II/III HDpatients recruited in 22 centers from 2010 to 2013 were randomized to DGHAL (n = 197) or SH (n = 196). The primary endpoint was operative-related morbidity at 3 months (D.90) based on the Clavien-Dindo surgical complications grading. Total cost, cost-effectiveness, and clinical outcome were assessed at 1 year. RESULTS: At D.90, operative-related adverse events occurred after DGHAL and SH, respectively, in 47 (24%) and 50 (26%) patients (P = 0.70). DGHAL resulted in longer mean operating time (44±16 vs 30±14 min; P < 0.001), less pain (postoperative and at 2 wks visual analogic scale: 2.2 vs 2.8; 1.3 vs 1.9; P = 0.03; P = 0.013) and shorter sick leave (12.3 vs 14.8 d; P = 0.045). At 1 year, DGHAL led to more residual grade III HD (15% vs 5%) and a higher reoperation rate (8% vs 4%). Patient satisfaction was >90% for both procedures. Total cost at 1 year was greater for DGHAL [&OV0556;2806 (&OV0556;2670; 2967) vs &OV0556;2538 (&OV0556;2386; 2737)]. The D.90, incremental cost-effectiveness ratio (ICER) was &OV0556;7192 per averted complication. At 1 year DGHAL strategy was dominated. CONCLUSIONS: DGHAL and SH are viable options in grade II/III HD with no significant difference in operative-related risk. Although resulting in less postoperative pain and shorter sick leave, DGHAL was more expensive, took longer, and provided a possible inferior anatomical correction suggesting an increased risk of recurrence.
Authors: Aurelien Venara; Juliette Podevin; Philippe Godeberge; Yann Redon; Marie-Line Barussaud; Igor Sielezneff; Michel Queralto; Cecile Bourbao; Anne Chiffoleau; Paul A Lehur Journal: Int J Colorectal Dis Date: 2018-05-28 Impact factor: 2.571
Authors: Angus J M Watson; Hanne Bruhn; Kathleen MacLeod; Alison McDonald; Gladys McPherson; Mary Kilonzo; John Norrie; Malcolm A Loudon; Kirsty McCormack; Brian Buckley; Steven Brown; Finlay Curran; David Jayne; Ramesh Rajagopal; Jonathan A Cook Journal: Trials Date: 2014-11-11 Impact factor: 2.279
Authors: Abualbishr Alshreef; Allan J Wailoo; Steven R Brown; James P Tiernan; Angus J M Watson; Katie Biggs; Mike Bradburn; Daniel Hind Journal: Pharmacoecon Open Date: 2017-09