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

Paul A. Lehur, MD, PhD; Anne S. Didnée, MD; Jean-Luc Faucheron, MD, PhD; Guillaume Meurette, MD, PhD; Philippe Zerbib, MD, PhD; Laurent Siproudhis, MD, PhD; Béatrice Vinson-Bonnet, MD; Anne Dubois, MD; Christine Casa, MD; Jean-Benoit Hardouin, PhD; Isabelle Durand-Zaleski, MD, PhD

Disclosures

Annals of Surgery. 2016;264(5):710-716. 

In This Article

Abstract and Introduction

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 [€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.

Introduction

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.[1] 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.[5] 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."

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