The February 'Paper of the Month' focusses on a proctological problem, the treatment of haemorrhoids. The paper considers for the first time not only clinical effectiveness but also cost-effectiveness and the long term quality of life following stapled haemorrhoidopexy (SH) and traditional excisional haemorrhoidectomy (TH) for patients with haemorrhoids. It was published in Health Technol Assessment Journal, which report studies supported by the HTA programme, part of the National Institute for Health Research (NIHR), UK.
Watson AJ, Cook J, Hudson J, Kilonzo M, Wood J, Bruhn H, Brown S, Buckley B, Curran F, Jayne D, Loudon M, Rajagopal R, McDonald A, Norrie J.
What is known on the subject?
Stapled haemorrhoidopexy (SH) was introduced into clinical practice for its potential advantages of a decreased postoperative pain, length of hospital stay, time to return to work over traditional surgery, making this technique very attractive to patients and health-care providers. However, multiple RCTs comparing SH with traditional haemorrhoidectomy (TH) and systematic reviews highlighted several uncertainties concerning recurrence of symptoms, costs and complications. Most of these studies showed less pain in the early postoperative period after SH, equivalent complication rate, but higher recurrence of symptoms and prolapse requiring re-intervention. However, most RCTs suffered from some methodological flaws with scarce information about quality of life and cost effectiveness. The same authors published last year in the Lancet the outcome of this trial looking at the clinical effectiveness of the two surgical techniques1, but in this HTA paper2 the cost effectiveness analysis, patient preference and the incentivisation trials (trial within a trial) data were also included.
What this study adds
In this RCT involving 777 patients (389 SH and 388 TH) recruited in 29 UK Hospitals, “the primary outcome was area under the quality-of-life curve measured using the EQ-5D-3L descriptive system over 24 months, and the primary economic outcome was the incremental cost-effectiveness ratio. Secondary outcomes included disease-specific quality of life, recurrence, complications, further interventions and costs”.
704 out of 774 randomized patients attended the 6 week clinical follow-up appointments and 562 attended the 24-month post-randomisation follow-up. The two groups were well matched for baseline clinical characteristics.
The primary outcome, EQ-5D-3L AUC over 24 months post randomisation, reported as QALYs, favoured TH (p = 0.034). The secondary analysis of AUC over six weeks post-surgery favoured SH but over 12 months post-randomisation the AUC showed no evidence of a difference between the two interventions.
The mean total cost per patient in the SH arm was £921.80, which was significantly higher than the mean cost of treatment in the TH arm of £620.65.
Implications for colorectal practice
Some of the findings in the previous RCT were confirmed, but there were a number of differences. For example, TH was associated with lower haemorrhoid recurrences, while SH was associated with less early postoperative pain and with a higher rate of recurrence. The eTHoS study did not confirm the higher complications rates, later return to normal activity and longer operation time and in hospital stay in TH group.
To quote the authors:
"Excisional surgery (TH) was both more clinically effective and less costly than SH. It was more painful in the short term, but this level of pain can be adequately managed at home. Return to normal activity rates were equal. In addition to superior quality-of-life scores, haemorrhoid symptoms scores, continence and tenesmus rates and the need for further surgery were all lower in TH. …TH is, therefore, a superior surgical treatment for the management of grades II–IV haemorrhoids when compared with SH in terms of clinical effectiveness and cost-effectiveness."
The findings of this study must be considered in national and international guidelines on the treatment of haemorrhoids and should be considered by colorectal surgeons. Patients waiting for surgery for hemorrhoids should be made aware of this.
References
- Watson AJ, Hudson J, Wood J, Kilonzo M, Brown SR, McDonald A, Norrie J, Bruhn H, Cook JA; eTHoS study group. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial.
Lancet. 2016 Nov 12;388(10058):2375-2385. doi: 10.1016/S0140-6736(16)31803-7. - Watson AJM, Cook J, Hudson J, Kilonzo M, Wood J, Bruhn H, et al. A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study. Health Technol Assess 2017;21(70).
