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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
  1. M A Thaha1,
  2. K L Campbell1,
  3. S A Kazmi1,
  4. L A Irvine1,
  5. A Khalil1,
  6. N R Binnie2,
  7. W S Hendry3,
  8. A Walker4,
  9. H J Staines5,
  10. R J C Steele1
  1. 1
    Colorectal Unit, Department of Surgery & Molecular Oncology, Ninewells Hospital & Medical School, University of Dundee, Dundee, UK
  2. 2
    Department of Surgery, Aberdeen Royal Infirmary, Aberdeen, UK
  3. 3
    Department of Surgery, Stirling Royal Infirmary, Stirling, UK
  4. 4
    Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK
  5. 5
    SIMBIOS, University of Abertay Dundee, Dundee, UK
  1. Mr M A Thaha, Department of Surgery & Molecular Oncology, Level 6, Ninewells Hospital & Medical School, University of Dundee, Dundee DD1 9SY, UK; m.a.thaha{at}dundee.ac.uk

Abstract

Objective: Unlike excisional haemorrhoidectomy, stapled anopexy (SA), which does not involve radical excision, has theoretical advantages, thus offering potential patient benefits. We compared the clinical efficacy, safety and patient acceptability of SA, with closed haemorrhoidectomy (CH).

Patients and methods: 182 patients with symptomatic haemorrhoids (grades II, III, IV) were randomly assigned to receive SA or CH and were followed for up to 1 year (6, 12, 24, 48 weeks) after operation. Postoperative pain, symptom control, complications, re-treatment rates, patient satisfaction, and quality of life were compared on an intention-to-treat basis.

Results: Postoperative pain in the SA group (n = 91) was significantly lower (p = 0.004, Mann–Whitney U test). At 1 year there were no significant differences in the symptom load, symptom severity or the disease severity between the two groups. Overall complication rates were similar but faecal urgency was reported more frequently following SA (p = 0.093, Fisher’s exact test). Despite a similar rate of residual symptoms, prolapse control was better with CH (p = 0.087, Fisher’s exact test), and more patients in the SA group required re-treatment for residual prolapse at 1 year (p = 0.037, Fisher’s exact test). However, more patients rated SA as an excellent operation at 6 and 12 weeks (p = 0.008 and 0.033, binary logistic regression) and were willing to undergo a repeat procedure if required (p = 0.018, Fisher’s exact test).

Conclusion: Stapled anopexy offers a significantly less painful alternative to excisional haemorrhoidectomy and achieves a higher patient acceptability. Although the overall symptom control and safety are similar in the majority of the patients, the re-treatment rate for recurrent prolapse at 1 year is higher following SA when compared to CH.

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Footnotes

  • Funding: Funding is received (accredited to the research grants, Department of Surgery & Molecular Oncology, University of Dundee, UK) from Ethicon Endo-surgery towards a clinical educational fellowship and Ethicon Endo-surgery provided the staplers free of cost for the trial. The trial protocol and design were driven by the lead researchers (MAT, KLC and RJCS) in Dundee without any influence or input from the sponsoring bodies. No feed-back of patient data will be made available to the sponsors. MAT and RJC have full access to all the data in the study and have the final responsibility for the decision to submit the work for publication without any constraints from the sponsors.

  • Competing interests: MAT is the recipient of the clinical research training fellowship from National Education Scotland (NES), previously Scottish Council for Postgraduate Medical and Dental Education (SCPMDE), and the Chief Scientist Office (CSO) of Scotland in August 2002. MAT also received an educational fellowship from Ethicon Endo-surgery, UK and Europe. The funding covered the salary towards a full-time clinical research fellowship in the Department of Surgery & Molecular Oncology, University of Dundee, educational costs towards research courses and travel to scientific meetings. No payment was received by any authors towards recruitment and conduct of the trial.

  • Ethics approval: The Tayside, Forth Valley and Grampian Research Ethics Committees approved the study (Tayside number 202/99) on 28 September 1999, with an amendment in 2000.

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