title: Cost-effectiveness of New Surgical Treatments for Hemorrhoidal Disease: A Multicentre Randomized Controlled Trial Comparing Transanal Doppler-guided Hemorrhoidal Artery Ligation With Mucopexy and Circular Stapled Hemorrhoidopexy.
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 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.affiliation: *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.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Lehur
authors.forename: Anne S
authors.initials: AS
authors.lastname: Didnée
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Faucheron
authors.forename: Guillaume
authors.initials: G
authors.lastname: Meurette
authors.forename: Philippe
authors.initials: P
authors.lastname: Zerbib
authors.forename: Laurent
authors.initials: L
authors.lastname: Siproudhis
authors.forename: Béatrice
authors.initials: B
authors.lastname: Vinson-Bonnet
authors.forename: Anne
authors.initials: A
authors.lastname: Dubois
authors.forename: Christine
authors.initials: C
authors.lastname: Casa
authors.forename: Jean-Benoit
authors.initials: JB
authors.lastname: Hardouin
authors.forename: Isabelle
authors.initials: I
authors.lastname: Durand-Zaleski
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D005260:Female; D006484:Hemorrhoids / Q000191:economics / Q000601:surgery*; D006801:Humans; D007223:Infant; D008026:Ligation / Q000009:adverse effects / Q000191:economics / Q000379:methods; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D017792:Surgical Stapling / Q000009:adverse effects / Q000191:economics*; D000067368:Transanal Endoscopic Surgery / Q000009:adverse effects / Q000191:economics* / Q000379:methods*; D018608:Ultrasonography, Doppler / Q000191:economics; D018084:Ultrasonography, Interventional / Q000009:adverse effects / Q000191:economics*; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000191:economics* / Q000379:methods; D055815:Young Adult