Abstract and Introduction
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 [€2806 (€2670; 2967) vs €2538 (€2386; 2737)]. The D.90, incremental cost-effectiveness ratio (ICER) was €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.
Hemorrhoidal disease (HD) is a common reason to see a colorectal specialist. The decision for surgery is often guided by the grade of hemorrhoidal prolapse. Patients with HD have several surgical options available to them, particularly with grade (G)II and GIII hemorrhoids; recent less invasive procedures include the following: stapled hemorrhoidopexy (SH) and subsequently Doppler-guided hemorrhoidal artery ligation (DGHAL).[2–6]
Stapled hemorrhoidopexy is widely performed in France with a tariff since 2007. SH is a standard treatment for GIII and selected GII HD despite rare adverse events (AEs).[7,8] As an alternative, DGHAL could be considered as less invasive, although not yet on the French tariff. Current literature contains only small randomized clinical trials (RCTs) between SH and DGHAL, and most studies are case studies.[9–11]
The cost of these techniques has yet to be compared, although HD surgery has significant implications for health service resources: the French database recorded 27,606 surgical procedures for HD in 2013; similar figures have been recorded in comparable countries.[12–14]
We report hereby the results of a multicenter RCT identified as "LigaLongo" and conducted under the auspices of the French Ministry of Health. The trial postulated the hypothesis that "DGHAL with less postoperative risk and a lower risk of sequelae is more cost-effective in comparison to SH."
Annals of Surgery. 2016;264(5):710-716. © 2016 Lippincott Williams & Wilkins