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

Discussion

Hemorrhoidal disease can be successfully treated using less aggressive surgery.[2] SH is associated with less pain and a faster recovery when compared with standard excisional hemorrhoidectomy. Despite the outlay on the disposable device, it can be cost-effective.[14,20] DGHAL based on a different concept is even less invasive, appropriate for outpatient surgery with low postoperative pain and reduced sick leave, as recently reported.[20] To date, there has been no significant study comparing the 2 procedures.

The present study also aimed to fill a gap between ongoing trials on HD management.[21–23] The "LigaLongo" trial was conducted within the day-to-day practice of 22 public centers, and should be interpreted in the context of the French healthcare system.

The primary endpoint differs from recent HD studies; although postoperative pain and length of stay are usually quoted, we focused on safety by looking at AEs according to the Clavien-Dindo grading system.[17,24] The hypothesis that DGHAL is less risky compared with SH has not been confirmed in this trial. However, switching to a noninferiority study, we can conclude that DGHAL does not produce a significantly higher risk than SH. In fact, our AE data are similar to previous studies.[24] DGHAL is, however, not without complications; significant postoperative pain and/or urinary retention were, respectively, reported in 13.0% and 8.6% of cases in a large series, with an overall morbidity of 18%.[21] In a smaller series, 24% of patients suffered complications after DGHAL with severe pain (16%), bleeding (7%), constipation (7%), local sepsis (6%), anal fissure (5%), and temporary incontinence (2%).[13] In another small RCT comparing DGHAL with open hemorrhoidectomy, whereas postoperative peak pain was significantly lower in DGHAL during the first week, there was no overall difference in pain.[26] However, DGHAL patients expressed earlier normal well-being, took less analgesics, and resumed professional activities earlier, as in the present trial. In this study, patients undergoing DGHAL had less postoperative pain and a faster return to work. Similarly, SH also seems to be a safe procedure without major complications and only a limited number of expected AEs.

In follow-up, both procedures showed equivalent results in terms of symptom reduction, QoL, and overall satisfaction. Long-term pain was not an issue in either group. Some SH patients experienced minor incontinence or urgency, not seen in the DGHAL group, but these symptoms did not persist. The excellent satisfaction rates after DGHAL in this study confirm other studies.[5,6,13,23,25] Residual or recurrent HD has been a concern after DGHAL, especially when performed for higher grades of HD, estimated at 8.7% at 12 months in a recent study. Other studies report between 0% and 20%.[10,12,21] Our findings of a higher number of GIII HD at 1 year after DGHAL, with the need for albeit minor procedures, are concerning, although long-term results with DGHAL are not yet available in current literature. Are the initial benefits offset by an increased risk of late failure as reported for SH?[2] Perhaps, careful patient selection, dietary advice, and hygienic behavior may improve long-term results.

This study is the first to perform a robust economic comparison between DGHAL and SH with careful collection of cost data.[27] It also provides solid data for resource allocation in the management of HD. We observed during the trial that DGHAL resulted in a modest but significant increase in healthcare costs, partly compensated by a decrease in sick leave. At 12 months, DGHAL seemed finally dominated. The resource utilization and costs of SH in our study were comparable with those previously reported.[14,28,29] A cost-utility analysis was not performed in the absence of a significant difference of SF36.[14] In this study, the duration of DGHAL and the OR occupation times were about 10 minutes longer than previously reported.[21,25] Although DGHAL was more frequently performed with outpatients than SH, the mean hospital length of stay was actually >1 day for DGHAL patients, longer than in other series. Reducing OR time and the length of stay for DGHAL could make the procedure cost-effective compared with SH. Indeed, is Doppler arterial guidance really necessary? Systematically positioning ligations and mucopexies around the anal canal may be sufficient as reported in a single-center RCT, potentially cutting time and equipment costs.[30]

Several limitations in our study need to be taken into account when interpreting the results. Firstly, we failed to reach the required sample size, although a reasonable cohort size for comparison was studied and a majority of patients were followed up at 1 year. The sample size allows the conclusion that DGHAL is certainly no worse when compared with SH in terms of complications. Secondly, we were unable to set up an independent postoperative assessment. However, independently filled questionnaires and records of any re-do surgery are solid data. Although investigators underwent training and had to perform 10 DGHAL before entering patients into the trial, they were probably less familiar with DGHAL.[13,26] Finally, the disparity in center recruitment could have affected the results (Table 1), although no significant center effect was identified.

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