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Journal of Chinese Integrative Medicine ›› 2006, Vol. 4 ›› Issue (2): 140-146.doi: 10.3736/jcim20060207

• Original Clinical Research • Previous Articles     Next Articles

Clinical research of thread-dragging through fistula method in treating patients with simple anorectal fistula

Jin-gen Lu, Yong-qing Cao, Chun-mei He, Xiu-tian Guo, Hong-xiang Huang, Jin Yi, Li-xin Xiao, Yu-min Xu, Min Ding, Yi-bin Pan, Chen Wang   

  1. Department of Anorectal Surgery, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai Clinical Medical Center for Chinese Traditional Surgery, Shanghai 200032, China
  • Online:2006-03-20 Published:2006-03-15

Objective

To evaluate the efficacy and safety of thread-dragging through fistula method in treating patients with simple anorectal fistula.

Methods

In this multi-centered, prospective, and randomized controlled clinical trial, 244 patients with simple low or high anorectal fistula were randomly divided into study group (with the method of thread-dragging through fistula) and control group (with the method of incision or thread-drawing). The healing time and curative rate of anorectal fistula, and the integral calculus of clinical symptom and life quality evaluations before and after treatment were all examined. The maximal anal canal squeeze pressure was measured to compare the therapeutic safety between these two groups. The health economical benefits were also assessed to determine which therapeutic method was more economical.

Results

The curative rate of simple low and high anorectal fistula were of no significant differences between the study group and the control group. The healing time of simple low anorectal fistula in the study group and the control group were (22.26±8.67) d and (31.41±11.39) d respectively, while the healing time of simple high anorectal fistula in the study group and the control group were (24.73±8.15) d and (32.20±12.60) d respectively, and there revealed significant differences between these two groups. Each integral calculus of clinical symptom evaluation in the study group was not obviously different from those in the control group besides the integral calculus of anal sphincter function. The integral calculus of life quality between the study group and the control group of simple low anorectal fistula had no significant differences. The integral calculus of anal sphincter function and confidence in treatment in the study group of high anorectal fistula were better than those in the control group. The hospitalization expense of the study group was remarkably lower than that of the control group. The maximal anal canal squeeze pressure in the study group after treatment was not reduced obviously as compared with that in the same group before treatment, while it was decreased significantly in the control group after treatment as compared with those in the same group before treatment and in the study group after treatment. 

Conclusion

The method of thread-dragging through fistula in treating simple low and high anorectal fistula can shorten the course of the disease, save the hospitalization expenses, improve the life quality of the patients, and protect the anal sphincter function.

Key words: Thread-dragging through fistula, Anal fistula, Anorectal surgery (TCM), Randomized controlled trials, Treatment outcome

CLC Number: 

  • R657.16

Table 1

Case distribution in three clinical centers"

Clinical centerCases includedCases dropped outCases rejectedCases included
in clinical trialsin statistical analysis
Longhua Hospital
Study group640163
Control group641063
Yueyang Hospital
Study group202018
Control group192017
Affiliated Hospital of Jiangxi College of TCM
Study group390039
Control group382036

Table 2

Comparison of age between two groups (ヌ±S, y)"

Groupn Age
Study
Low anorectal fistula6639.3±10.7
High anorectal fistula5740.2±12.7
Control
Low anorectal fistula6537.5±13.3
High anorectal fistula5640.9±11.7

Table 3

Comparison of gender composition between two groups[n (%)]"

GroupGender
MaleFemale
Study
Low anorectal fistula51 (77.27)15 (22.73)
High anorectal fistula49 (85.96)8 (14.04)
Control
Low anorectal fistula48 (73.85)17 (26.15)
High anorectal fistula40 (71.43)16 (28.57)

Table 4

Comparisons of integral calculus (IC) of clinical symptom and life quality evaluations between two groups"

Clinical symptom and life qualityLow anorectal fistulaHigh anorectal fistula
nW valueP valuenW valueP value
Clinical symptom evaluation
Study661.000.15571.930.23
Control6556
Anal sphincter function
Study660.540.46570.540.46
Control6556
Emotion evaluation
Study662.250.13570.600.44
Control6556
Confidence in treatment
Study660.830.36571.350.25
Control6556

Table 5

Comparison of healing time of anorectal fistula between two groups"

Groupn Healing time (ヌ±S, d)t valueP value
High anorectal fistula
Study5624.73±8.153.69<0.01
Control5332.20±12.60
Low anorectal fistula
Study6422.26±8.675.10<0.01
Control6331.41±11.39

Table 6

Comparison of curative rate of anorectal fistula between two groups"

Groupn Recovery
completely (%)
Recovery
partly (%)
High anorectal fistula
Study5654 (96.4)2 (3.6)
Control5353 (100.0)0 (0)
Low anorectal fistula
Study6463 (98.4)1 (1.6)
Control6361 (96.8)2 (3.2)

Table 7

Comparisons of integral calculus (IC) of clinical symptom evaluation between two groups with low anorectal fistula"

Clinical symptomnIC
Before treatmentAt recoveryAfter follow-up of 3 months
Pain
Study642.660.710.08
Control632.390.890.14
Anal sphincter function
Study640.080.17**0.03**
Control630.080.340.11
Total
Study649.551.150.20
Control639.021.500.31

Table 8

Comparisons of integral calculus (IC) of clinical symptom evaluation between two groups with high anorectal fistula"

Clinical symptomnIC
Before treatmentAt recoveryAfter follow-up of 3 months
Pain
Study562.380.720.07
Control532.330.790.29
Anal sphincter function
Study560.020.04**0.02**
Control530.080.430.24
Total
Study5610.51.220.18
Control53102.170.71

Table 9

Comparisons of integral calculus (IC) of life quality evaluation between two groups with low anorectal fistula"

Life qualitynIC
Before treatmentAt recoveryAfter follow-up of 3 months
Pain
Study642.980.550.12
Control632.690.840.16
Clincal symptoms
Study647.720.600.14
Control637.090.850.16
Anal sphincter function
Study640.190.340.08
Control630.200.520.13
Emotion evaluation
Study644.570.290.08
Control633.820.290.13
Confidence in treatment
Study643.694.254.47
Control633.524.214.50

Table 10

Comparisons of integral calculus (IC) of life quality evaluation between two groups with high anorectal fistula"

Life qualitynIC
Before treatmentAt recoveryAfter follow-up of 3 months
Pain
Study562.590.790.07
Control532.420.730.25
Clincal symptoms
Study567.110.980.15
Control536.361.020.27
Anal sphincter function
Study560.150.26*0.05*
Control530.180.610.21
Emotion evaluation
Study563.260.240.04
Control532.980.560.13
Confidence in treatment
Study562.824.22*4.56*
Control532.493.113.25

Table 11

Comparisons of index of health economics between two groups"

Groupn Ratio of drug usage (%)Hospitalization expenses (?x±s, yuan)
Low anorectal fistula
Study6421.68±9.492 763.99±994.25**
Control6321.17±8.963 504.51±1 196.06
High anorectal fistula
Study5621.97±0.063 168.55±856.75**
Control5320.27±0.084 076.55±1 311.32

Table 12

Comparisons of maximal anal canal squeeze pressure between two groups (ヌ±S, kPa)"

GroupnMaximal anal canal squeeze pressure
Before treatmentAfter treatment
Low anorectal fistula
Study6425.38±8.3223.87±8.11
Control6326.51±9.1218.21±10.26*
High anorectal fistula
Study5624.17±7.6422.44±6.39
Control5325.51±8.1215.36±10.11*
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