Prospective randomised multi-centre trial comparing the clinical efficacy, safety and patient acceptability of circular stapled anopexy with closed diathermy haemorrhoidectomy

Thaha, Mohamed A.; Campbell, Kenneth L.; Kazmi, Syed Atif Mehmood; Irvine, L. A.; Khalil, Ahmed Al; Binnie, N. R.; Hendry, Wilson S.; Walker, Andrew; Staines, Harry; Steele, Robert

doi:10.1136/gut.2008.151266

Cited by 46 publications

(32 citation statements)

References 26 publications

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“…These scenarios (A and B) were a simplification of the expectation regarding SH and TH at the initiation of the study, given previous evidence. 2,13 Details of how the baseline questionnaire data were collected and information relating to the study design are provided in Chapter 3. …”

Section: Methodsmentioning

confidence: 99%

“…SH thus appeared to be associated with less pain in the immediate postoperative period, but a higher rate of recurrence in the longer term and an increased need for further surgery. 13 These findings were based on data from small trials, all with methodological flaws, and provided only limited data on quality of life (or, with respect to an economic interpretation, health-state utilities) in the early postoperative period.…”

Section: Evidence Leading To the Inception Of The Ethos Studymentioning

confidence: 99%

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A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study

Watson

Cook

Hudson

et al. 2017

Health Technol Assess

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BackgroundHaemorrhoids are a benign anorectal condition and are highly prevalent in the UK population. Treatments involve clinic-based procedures and surgery. The surgical procedures available include stapled haemorrhoidopexy (SH) and traditional haemorrhoidectomy (TH), and over 25,000 operations are performed for haemorrhoids annually in the UK. The disease is therefore important both to patients and to health service commissioners. Debate remains as to which of these surgical procedures is the most clinically effective and cost-effective.ObjectiveThe aim of this study was to compare the clinical effectiveness and cost-effectiveness of SH with that of TH.DesignA large, open two-arm parallel-group pragmatic multicentre randomised controlled trial involving 32 UK hospitals and a within-trial cost–benefit analysis. A discrete choice experiment was conducted to estimate benefits (willingness to pay).ParticipantsPatients with grades II–IV haemorrhoids who had not previously undergone SH or TH were included in the study.InterventionsParticipants were randomised to receive either SH or TH. Randomisation was minimised at 1 : 1, in accordance with baseline EuroQol-5 Dimensions, three-level version (EQ-5D-3L) score, haemorrhoid grade, sex and centre, via an automated system.Main outcome measuresThe 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.ResultsBetween January 2011 and August 2014, 777 patients were randomised (389 to receive SH and 388 to receive TH). There were 774 participants included in the analysis as a result of one post-randomisation exclusion in the SH arm and two in the TH arm. SH was less painful than TH in the short term. Surgical complications were similar in both arms. EQ-5D-3L score was higher for the SH arm in the first 6 weeks after surgery, but over 24 months the TH group had significantly better EQ-5D-3L scores (–0.073, 95% confidence interval –0.140 to –0.006;p = 0.0342). Symptoms and further interventions were significantly fewer in the TH arm at 24 months. Continence was better in the TH arm and tenesmus occurred less frequently. The number of serious adverse events reported was 24 out of 337 (7.1%) for participants who received SH and 33 out of 352 (9.4%) for those who received TH. There were two deaths in the SH arm, both unrelated to the eTHoS (either Traditional Haemorrhoidectomy or Stapled haemorrhoidopexy for haemorrhoidal disease) study. Patient preference did not seem to influence the treatment difference. SH was dominated by TH as it cost more and was less effective. The net benefit for the TH arm was higher than that for the SH arm.LimitationsNeither the participants nor the assessors were masked to treatment assignment and final recruitment was slightly short of the total target of 800. There were also substantial missing follow-up data.ConclusionsWhile patients who received SH had less short-term pain, after 6 weeks, recurrence rates, symptoms, re-interventions and quality-of-life measures all favoured TH. In addition, TH is cheaper. As part of a tailored management plan for haemorrhoids, TH should be considered over SH as the surgical treatment of choice for haemorrhoids refractory to clinic-based interventions.Future workPerform an updated meta-analysis incorporating recently conducted European trials [eTHoS, HubBLe (haemorrhoidal artery ligation versus rubber band ligation for the management of symptomatic second-degree and third-degree haemorrhoids) and LingaLongo (Cost-effectiveness of New Surgical Treatments for Haemorrhoidal Disease)].Trial registrationCurrent Controlled Trials ISRCTN80061723.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 70. See the NIHR Journals Library website for further project information.

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Section: Methodsmentioning

confidence: 99%

Section: Evidence Leading To the Inception Of The Ethos Studymentioning

confidence: 99%

A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study

Watson

Cook

Hudson

et al. 2017

Health Technol Assess

View full text Add to dashboard Cite

show abstract

“…This obviously shacked the scientific community , creating debate and obviously a series os scientific researches comparing the classical excisional technique [8,9] to the other and trying to establish a new pathway of treatment and finally define what to do and in which kind of patients. After a short period of trials, some negative point arose around the Longo technique [10][11][12][13][14][15][16][17][18], with this debate still in place in congresses and symposium around the word and in modern literature [16].…”

mentioning

confidence: 99%

Hemorrhoidal Disease, from Legacy to a Change of Perspective

Morelli¹

2015

Int J Gastroenterol Disord Ther

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“…A very recent study assessed quality of life, patients' satisfaction, and patients' approval of the procedure and their willingness for a repeat procedure. The authors conc l u d e d t h a t w h e n co m p a r e d w i t h c o n v e n t i on a l hemorrhoidectomy stapled hemorrhoidopexy is favored by the patients [75].…”

Section: Resultsmentioning

confidence: 99%

Clinical Outcome Following Hemorrhoid Surgery: a Narrative Review

Picchio¹,

Greco²,

Filippo

et al. 2014

Indian J Surg

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Surgical therapy guaranties satisfactory results, which are significantly better than those obtained with conservative therapies, especially for Grade III and IV hemorrhoids. In this review, we present and discuss the results of the most diffuse surgical techniques for hemorrhoids. Traditional surgery for hemorrhoids aims to remove the hemorrhoids, with closure (Fergusson's technique) or without closure (Milligan-Morgan procedure) of the ensuing defect. This traditional approach is effective, but causes a significant postoperative pain because of wide external wounds in the innervated perianal skin. Stapled hemorrhoidopexy, proposed by Longo, has gained a vast acceptance because of less postoperative pain and faster return to normal activities. In the recent literature, a significant incidence of recurrence after stapled hemorrhoidopexy was reported, when compared with conventional hemorrhoidectomy. Double stapler hemorrhoidopexy may be an alternative to simple stapled hemorrhoidopexy to reduce the recurrence in advanced hemorrhoidal prolapse. Transanal hemorrhoidal deartertialization was showed to be as effective as stapled hemorrhoidopexy in terms of treatment success, complications, and incidence recurrence. However, further high-quality trials are recommended to assess the efficacy and safety of this technique.

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Prospective randomised multi-centre trial comparing the clinical efficacy, safety and patient acceptability of circular stapled anopexy with closed diathermy haemorrhoidectomy

Cited by 46 publications

References 26 publications

A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study

A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study

Hemorrhoidal Disease, from Legacy to a Change of Perspective

Clinical Outcome Following Hemorrhoid Surgery: a Narrative Review

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