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Effect of High Suspension and Low Incision Surgery Based on Traditional Ligation of Chinese Medicine in Treatment of Mixed Haemorrhoids: A Multi-centre, Randomized, Single-Blind, Non-inferiority Clinical Trial

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Chinese Journal of Integrative Medicine Aims and scope Submit manuscript

Abstract

Objective

To observe the clinical effect of high suspension and low incision (HSLI) surgery on mixed haemorrhoids, compared with Milligan-Morgan haemorrhoidectomy.

Methods

A multi-centre, randomized, single-blind, non-inferiority clinical trial was performed. Participants with mixed haemorrhoids from Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing Rectum Hospital, Air Force Medical Center of People’s Liberation Army of China, and Puyang Hospital of Traditional Chinese Medicine were enrolled from September 2016 to March 2018. By using a blocked randomization scheme, participants were assigned to two groups. The experimental group was treated with HSLI, while the control group was treated with Milligan-Morgan haemorrhoidectomy. The primary outcome was the clinical effect evaluated at 12 weeks after operation. The secondary outcomes included the number of haemorrhoids treated during the operation, pain scores, use of analgesics, postoperative oedema, wound healing, incidence of anal stenosis, anorectal manometry after operation, as well as surgical duration, length of stay and total hospitalization expenses. A safety evaluation was also conducted.

Results

In total, 246 eligible participants were enrolled, with 123 cases in each group. There was no significant difference in the clinical effect between the two groups (100.00% vs. 99.19%, P>0.05). Compared with the control group, the number of external haemorrhoids treated during the operation and the pain scores after operation were significantly reduced in the experimental group (P<0.05 or P<0.01); the patient number with wound healing at 2 weeks after operation and the functional length of anal canal at 12 weeks after operation were significantly increased in the experimental group (P<0.05). There was no significant difference in the incidence of anal stenosis, the numbers of patients using analgesics and patients with postoperative oedema between the two groups after operation (P>0.05). The surgical duration and length of stay in the experimental group were significantly longer than those in the control group, and the total hospitalization expense was significantly higher than that in the control group (all P<0.05). No adverse events were reported in either group during the whole trial or follow-up period.

Conclusion

HSLI had the advantages of preserving the skin of anal canal completely, alleviating postsurgical pain and promoting rapid recovery after operation. (Registration No. ChiCTR1900022883)

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Acknowledgements

We would like to thank Lea Moore for providing editorial assistance, also thank Miss ZHAO Yang from Xiyuan Hospital of China Academy of Chinese Medical Sciences for providing statistical consultation.

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Authors and Affiliations

  1. Department of Anorectal, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China

    Xiao-qiang Jia, Wei-wei Cao, Long-fang Quan, Wei-bing Zhao, Fang Cheng, Zhen-nian Xie, Dong Wang, Chun-yan Xu, Chun-hui Cui, Xing-juan Cai, Lan-ye He, Liang Su & Meng-fan Zhai

  2. Department of Anorectal, Beijing Rectum Hospital, Beijing, 100120, China

    Shan Jia, Zhan-jun Wang & Ying Tian

  3. Department of Anorectal, Air Force Medical Center, People’s Liberation Army of China, Beijing, 100089, China

    Liu-quan Feng & Shu-min Shi

  4. Department of Anorectal, Puyang Hospital of Traditional Chinese Medicine, Puyang, Henan Province, 457001, China

    Xu-feng Wei & Si-miao Sun

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  1. Xiao-qiang Jia
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  2. Wei-wei Cao
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  18. Si-miao Sun
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  19. Liang Su
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  20. Meng-fan Zhai
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Contributions

Jia XQ participated in the design of this study. Cao WW, Quan LF, Zhao WB, Cheng F, Jia S, Feng LQ, Wei XF, Xie ZN, Wang ZJ, Tian Y, Shi SM, Sun SM and Zhai MF provided assistance for data acquisition. Wang D, Xu CY, Cai XJ, Cui CH and Su L performed the statistical analysis. He LY drafted the manuscript. All authors read and approved the final version of the paper.

Corresponding author

Correspondence to Xiao-qiang Jia.

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The authors have no financial associations or any other conflicts of interests to declare.

Additional information

Supported by the Capital Featured Clinical Application and Promotion Project (No. Z151100004015082), Basic Research Business Fees Independent Selection Project of China Academy of Chinese Medical Sciences (No. ZZ0908002), and Cultivation Project of National Natural Science Foundation of China in Xiyuan Hospital, China Academy of Chinese Medical Sciences (No. XY20-16)

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Jia, Xq., Cao, Ww., Quan, Lf. et al. Effect of High Suspension and Low Incision Surgery Based on Traditional Ligation of Chinese Medicine in Treatment of Mixed Haemorrhoids: A Multi-centre, Randomized, Single-Blind, Non-inferiority Clinical Trial. Chin. J. Integr. Med. 27, 649–655 (2021). https://doi.org/10.1007/s11655-021-3329-2

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  • DOI: https://doi.org/10.1007/s11655-021-3329-2

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