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

Xiao-qiang JIA; Wei-wei CAO; Long-fang QUAN; Wei-bing ZHAO; Fang CHENG; Shan JIA; Liu-quan FENG; Xu-feng WEI; Zhen-nian XIE; Dong WANG; Chun-yan XU; Chun-hui CUI; Xing-juan CAI; Lan-ye HE; Zhan-jun WANG; Ying TIAN; Shu-min SHI; Si-miao SUN; Liang SU; Meng-fan ZHAI

doi:10.1007/s11655-021-3329-2

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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

Original Article | Updated：2021-09-01

- 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
- 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
- Chinese Journal of Integrative Medicine 2021年27卷第9期页码：649-655
- Affiliations：
  
  1.Department of Anorectal, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing(100091), China
  2.Department of Anorectal, Beijing Rectum Hospital, Beijing(100120), China
  3.Department of Anorectal, Air Force Medical Center, People's Liberation Army of China, Beijing(100089), China
  4.Department of Anorectal, Puyang Hospital of Traditional Chinese Medicine, Puyang, Henan Province (457001), China
- Author bio：
  
  Prof. JIA Xiao-qiang, E-mail: jxq391@sina.com
- Funds：
  
  the Capital Featured Clinical Application and Promotion Project(Z151100004015082);Basic Research Business Fees Independent Selection Project of China Academy of Chinese Medical Sciences(ZZ0908002);Cultivation Project of National Natural Science Foundation of China in Xiyuan Hospital, China Academy of Chinese Medical Sciences(XY20-16)
- DOI：10.1007/s11655-021-3329-2
  中图分类号：
- 纸质出版日期：2021-09-01，
  
  网络出版日期：2021-03-12，
  
  录用日期：2020-05-18
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Xiao-qiang JIA, Wei-wei CAO, Long-fang QUAN, 等. 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[J]. Chinese Journal of Integrative Medicine, 2021,27(9):649-655.

Xiao-qiang JIA, Wei-wei CAO, Long-fang QUAN, 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[J]. Chinese Journal of Integrative Medicine, 2021,27(9):649-655.
Xiao-qiang JIA, Wei-wei CAO, Long-fang QUAN, 等. 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[J]. Chinese Journal of Integrative Medicine, 2021,27(9):649-655. DOI： 10.1007/s11655-021-3329-2.

Xiao-qiang JIA, Wei-wei CAO, Long-fang QUAN, 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[J]. Chinese Journal of Integrative Medicine, 2021,27(9):649-655. DOI： 10.1007/s11655-021-3329-2.

摘要

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

singleblind

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%

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 (

0.05 or

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 (

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 (

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

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)

关键词

Keywords

mixed haemorrhoidshigh suspension and low incision surgeryrandomized controlled trialMilligan-Morgan haemorrhoidectomy

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