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

Results

Baseline

Twenty-two French public institutions with expertise in the management of HD registered as investigators. Over a period of 29 months (September 2010–January 2013), ending with the last follow-up visit on February 28, 2014, 407 patients (DGHAL n = 203; SH n = 204) were recruited (Fig. 1).

Figure 1.

Flow chart—''LigaLongo'' RCT. Note: 14 patients excluded in the modified intention-to-treat (mITT) population.

At baseline, the 2 groups were well matched (Table 1). Respectively, 91(23%) and 302 (77%) patients had GII and GIII HD, which was circumferential in 27%. No difference was found at baseline with respect to pain levels, symptoms, disease severity score, QoL, or stool consistency (see SDC3, Table 1, http://links.lww.com/SLA/B20).

Surgery

The procedure was performed under general anesthesia in 94% of cases within half a Ropivacaine pudendal nerve block. The procedure was completed in a time of 37±16 minutes (range 9–94). The duration of the procedure and operating room (OR) occupation was significantly longer with DGHAL (see SDC4, Fig. 1, http://links.lww.com/SLA/B20). The number of arterial ligations and mucopexies was, respectively, 7.3 ± 2.4 and 3.6 ± 1.9. In the SH group, the staple line was 2.5 ± 2.0 cm above the dentate line. Doughnut width was 2.8 ± 1.2 cm. HD external components were excised in 11% of cases with DGHAL and 9% with SH.

The assigned procedure was not performed for 12 patients (see SDC5, Text 3, http://links.lww.com/SLA/B20). Intraoperative device dysfunctions were reported in 12 DGHAL (nonfunctioning Doppler probe) and 2 SH (purse string fracture, empty staple cartridge) procedures.

Hospital Stay

Mean hospital stay was 1.2 ± 1.2 days in each group. Outpatient surgery was more often performed for DGHAL (n = 64, 35% vs n = 52, 25%; P = 0.20). Visual analogic scale pain score on discharge was significantly less for DGHAL (2.2 ± 1.9 vs 2.8 ± 2.2; P = 0.003). In-hospital operative-related AEs were reported for 23 patients (6%) (DGHAL: 10; SH: 13; NS), and the most frequent complication was urinary retention (DGHAL: 6; SH: 4).

Follow-up to D.90

Primary Endpoint at D.90. Ninety-seven patients (25%; DGHAL: 47, SH: 50) experienced 1 or more procedure-related postoperative AEs before D.90, including those recorded during hospitalization (Table 2). One hundred fourteen AEs occurring in 63 patients were deemed not procedure-related. No statistical difference was found between the 2 groups with respect to the trial hypothesis, and as foreseen in the protocol, a switch to a noninferiority analysis was performed. Since the CI entirety (0%; 28.9%) is above the obtained value (30.6%), the noninferiority of DGHAL versus SH in terms of rate of complications at D.90 with a 5% type I error was demonstrated and confirmed in the per-protocol analysis [the 95% unilateral CI (0%; 30.5%) does not include the 33.5% threshold].

Secondary Clinical Endpoints at D.90. There was a statistical difference in pain levels (1.3 ± 1.9 vs 1.9 ± 2.1; P = 0.013) during the second postoperative week, but not in analgesic requirements (37% vs 44%; P = 0.17). At D.90, pain levels (1.1 ± 1.9 vs 1.2 ± 1.8; P = 0.57) and analgesic requirements (5 vs 10; P = 0.18) were similar. One hundred sixty-six out of 253 working patients (62.1%) had an initial sick leave of 13.6 ± 7.8 days (DGHAL: 12.4 ± 8.2 vs SH: 14.8 ± 7.3; P = 0.045) and 21 (DGHAL: 7 vs SH: 14; P = 0.11) delayed returning to work (DGHAL: 17.6 ± 22.0 vs SH: 24.9 ± 23.0 d; P = 0.37).

Seventeen patients were readmitted up to D.15 (DGHAL: 9; SH: 8). Reasons included bleeding (DGHAL: 3; SH: 4), urinary retention (DGHAL: 3; SH: 2), thrombosis/abscess (DGHAL: 3; SH: 2). From D.15 to D.90, only 1 SH patient was readmitted (painful chronic fissure; Table 2).

Follow-up From D.90 to 1 Year. At M.6 and M.12, 338 (86%) and 329 (84%) patients were re-assessed (DGHAL: 170, 167; SH: 168, 162; Table 2).

At M.6, proctologic examination was considered difficult in 4 and 7 patients (P = 0.54). Hypertrophic external hemorrhoids (35.2% vs 17.1%; P = 0.006) and hemorrhoidal prolapse (25.1% vs 13.8%; P = 0.049) were significantly more common after DGHAL. GIII hemorrhoids were seen in 9% and 4% of the patients (P = 0.27).

At M.12, data on anal examinations were similar to that at M.6, with more GIII HD after DGHAL (15% vs 5%; P = 0.007). There was no difference in pain levels (DGHAL 1.0 ± 1.9 vs SH 0.9 ± 1.6; P = 0.47), analgesics (5 vs 2; P = 0.28), QoL, and satisfaction score (82.8 ± 25.6 vs 83.1 ± 25.1; P = 0.94)[7] (see SDC3, Table 1, http://links.lww.com/SLA/B20). Both groups (DGHAL 93%, SH 94%; P = 0.67) would recommend their operation (see SDC3, Table 1, http://links.lww.com/SLA/B20).

From D.90 to M.12, 47 patients (25%) experienced HD problems. Sixteen (8%) DGHAL and 7 (4%) SH (P = 0.055) required further surgery and sick leave (7 vs 4 cases). No unusual complications were reported.

Health Economics

Cost comparison for the index admission procedure and the contribution of each cost item to uncertainty at D.90 and M.12 are presented (Table 3; see SDC6, Tornado diagram 1, http://links.lww.com/SLA/B20).

At D.90 and M.12, mean direct and indirect total cost was higher for DGHAL than for SH, respectively, by €198 (P < 0.001) and €268 (P < 0.001). At D.90, there was a 67% chance that DGHAL would be more effective but also more costly than SH, with an ICER of €7192 (direct and indirect costs) or €12,007 (direct costs only) per averted complication, whereas at M.12, DHGAL was less effective and more costly (ie, dominated; Fig. 2).

Figure 2.

Uncertainty associated with cost-effectiveness as scatter plot of mean cost and mean effectiveness differences. Note: D.90 and M.12 cost and effectiveness of DGHAL versus SH. Costs (in €2015) include direct healthcare cost and compensated days-off work. Effectiveness is measured by the rate of patients with at least 1 postoperative complication or repeat intervention during the initial admission and follow-up period. At D.90, 67% of replications are located in the upper right quadrant, indicating that DGHAL is more expensive and more efficient than SH. At M.12, 85% of replications are located in the upper left quadrant, indicating that DGHAL is still more expensive, but less efficient (ie, dominated) than SH.

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