Randomised controlled trial comparing rubber band ligation with stapled haemorrhoidopexy for Grade II circumferential haemorrhoids: Long-term results

V. Shanmugam, G. Muthukumarasamy, Jonathan Alistair Cook, Luke David Vale, Angus Watson, M. A. Loudon

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Abstract

Objective An improved understanding of the pathophysiology of haemorrhoids has resulted in the introduction of new surgical techniques including stapled haemorrhoidopexy (SH). This randomized controlled trial compared the long-term effectiveness of SH with rubber band ligation (RBL) in the treatment of grade II circumferential symptomatic haemorrhoids.

Method A consecutive cohort of patients was randomly allocated to either SH or RBL. Data on haemorrhoidal symptoms, Cleveland continence scores, sphincter assessment, SF-36, EQ-5D, HAD score and prior treatment history were assessed at enrolment and reassessed by long-term postal questionnaire. The details were analysed using spssTM 12.0 from MicrosoftTM Access®.

Results Sixty patients were allocated by computer block randomization. Both groups were balanced for age, sex and symptoms. Recurrence favoured SH [3 vs 11; OR 0.18, 95% CI (0.03 to 0.86), P = 0.028] at 1 year and, at a mean of 40.67 (31–47) months [4 vs 12; OR 0.23, 95% CI (0.05, 0.95); P = 0.039]. SH patients experienced prolonged pain [Median (IQR) = 7 (5,7) vs 3 (1,7), P = 0.008] and took a longer time to return to work [6 (3,7) vs 3 (1,6) days, P = 0.018]. This was no significant difference in quality of life.

Conclusion Stapled haemorrhoidopexy achieved better disease control at 1 year without any major complication. This was sustained in the long-term. Further studies with greater patient numbers are needed to confirm this study.
Original languageEnglish
Pages (from-to)579-586
Number of pages8
JournalColorectal Disease
Volume12
Issue number6
Early online date27 Mar 2009
DOIs
Publication statusPublished - Jun 2010

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Hemorrhoids
Rubber
Ligation
Randomized Controlled Trials
Return to Work
Random Allocation
History
Quality of Life
Recurrence
Pain
Therapeutics

Keywords

  • haemorrhoids
  • stapled haemorrhoidopexy
  • rubber band ligation
  • randomized controlled trial

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Randomised controlled trial comparing rubber band ligation with stapled haemorrhoidopexy for Grade II circumferential haemorrhoids : Long-term results. / Shanmugam, V.; Muthukumarasamy, G.; Cook, Jonathan Alistair; Vale, Luke David; Watson, Angus; Loudon, M. A.

In: Colorectal Disease, Vol. 12, No. 6, 06.2010, p. 579-586.

Research output: Contribution to journalArticle

Shanmugam, V. ; Muthukumarasamy, G. ; Cook, Jonathan Alistair ; Vale, Luke David ; Watson, Angus ; Loudon, M. A. / Randomised controlled trial comparing rubber band ligation with stapled haemorrhoidopexy for Grade II circumferential haemorrhoids : Long-term results. In: Colorectal Disease. 2010 ; Vol. 12, No. 6. pp. 579-586.
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N2 - Objective An improved understanding of the pathophysiology of haemorrhoids has resulted in the introduction of new surgical techniques including stapled haemorrhoidopexy (SH). This randomized controlled trial compared the long-term effectiveness of SH with rubber band ligation (RBL) in the treatment of grade II circumferential symptomatic haemorrhoids. Method A consecutive cohort of patients was randomly allocated to either SH or RBL. Data on haemorrhoidal symptoms, Cleveland continence scores, sphincter assessment, SF-36, EQ-5D, HAD score and prior treatment history were assessed at enrolment and reassessed by long-term postal questionnaire. The details were analysed using spssTM 12.0 from MicrosoftTM Access®. Results Sixty patients were allocated by computer block randomization. Both groups were balanced for age, sex and symptoms. Recurrence favoured SH [3 vs 11; OR 0.18, 95% CI (0.03 to 0.86), P = 0.028] at 1 year and, at a mean of 40.67 (31–47) months [4 vs 12; OR 0.23, 95% CI (0.05, 0.95); P = 0.039]. SH patients experienced prolonged pain [Median (IQR) = 7 (5,7) vs 3 (1,7), P = 0.008] and took a longer time to return to work [6 (3,7) vs 3 (1,6) days, P = 0.018]. This was no significant difference in quality of life. Conclusion Stapled haemorrhoidopexy achieved better disease control at 1 year without any major complication. This was sustained in the long-term. Further studies with greater patient numbers are needed to confirm this study.

AB - Objective An improved understanding of the pathophysiology of haemorrhoids has resulted in the introduction of new surgical techniques including stapled haemorrhoidopexy (SH). This randomized controlled trial compared the long-term effectiveness of SH with rubber band ligation (RBL) in the treatment of grade II circumferential symptomatic haemorrhoids. Method A consecutive cohort of patients was randomly allocated to either SH or RBL. Data on haemorrhoidal symptoms, Cleveland continence scores, sphincter assessment, SF-36, EQ-5D, HAD score and prior treatment history were assessed at enrolment and reassessed by long-term postal questionnaire. The details were analysed using spssTM 12.0 from MicrosoftTM Access®. Results Sixty patients were allocated by computer block randomization. Both groups were balanced for age, sex and symptoms. Recurrence favoured SH [3 vs 11; OR 0.18, 95% CI (0.03 to 0.86), P = 0.028] at 1 year and, at a mean of 40.67 (31–47) months [4 vs 12; OR 0.23, 95% CI (0.05, 0.95); P = 0.039]. SH patients experienced prolonged pain [Median (IQR) = 7 (5,7) vs 3 (1,7), P = 0.008] and took a longer time to return to work [6 (3,7) vs 3 (1,6) days, P = 0.018]. This was no significant difference in quality of life. Conclusion Stapled haemorrhoidopexy achieved better disease control at 1 year without any major complication. This was sustained in the long-term. Further studies with greater patient numbers are needed to confirm this study.

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