Botulinum toxin for chronic anal fissure after biliopancreatic diversion for morbid obesity

Table 1 Parameters considered in the analysis of 59 patients who were treated with botulinum toxin for chronic anal fissure and had previously undergone biliopancreatic diversion

	Frequency	Percent (%)
Age (yr)
≤ 30	12	20.3
31-40	19	32.2
41-50	15	25.4
> 50	13	22.0
Sex
Female	38	64.4
Male	21	35.6
Duration of symptoms (mo)
≤ 7	31	52.5
> 7	28	47.5
Postdefecatory anal pain
Present	58	98.3
Absent	1	1.7
Nocturnal anal pain
Present	17	28.8
Absent	42	71.2
Anal pain unrelated to defecation
Present	22	37.3
Absent	37	62.7
Bleeding
Present	44	74.6
Absent	15	25.4
Mucorrhea
Present	13	22.0
Absent	46	78.0
Other anal pathologies
Present	7	11.9
Absent	52	88.1
Extra-anal pathologies
Present	23	39.0
Absent	36	61.0
Defecation pattern
Normal	5	8.5
Diarrhea	50	84.7
Constipation	4	6.8
Stool consistency
Formed	5	8.5
Soft	50	84.7
Hard	4	6.8
Number of evacuations per week
≤ 7	6	10.2
> 7	53	89.8
Straining
Present	3	5.1
Absent	56	94.9
Incomplete evacuations
Present	3	5.1
Absent	56	94.9
Laxative use
Yes	3	5.1
No	56	94.9
Enemas/suppositories use
Yes	3	5.1
No	56	94.9
Location of fissure
Posterior midline	54	91.5
Anterior midline	3	5.1
Others	2	3.4

Table 2 Results of treatment with botulinum toxin A

	Frequency	Percent (%)
Botox dose
20 IU	3	5.1
30 IU	11	18.6
50 IU	45	76.3
Site of injection
Unspecified - internal sphincter	1	1.7
Posterior side internal sphincter	2	3.4
Anterior side internal sphincter	56	94.9
Resting anal tone
Normal	1	1.7
Increased	58	98.3
Maximal voluntary anal squeeze
Normal	4	6.8
Increased	53	89.8
Decreased	2	3.4
Pubo-rectal muscle relaxation
Present	58	98.3
Absent	1	1.7

Table 3 Manometric data before, and 1 and 2 mo after botulinum toxin treatment (mean ± SD)

Time	Resting anal pressure (mmHg)	Maximum voluntary anal squeeze pressure (mmHg)
Baseline	107.1 ± 20.0	78.2 ± 17.0
1 mo	84.4 ± 23.6b	70.9 ± 18.3a
2 mo	82.3 ± 22.7b	70.1 ± 19.2

All patients were included in all evaluations.

^aP = 0.036,

^bP < 0.001 vs baseline.

Table 4 Univariate analysis of parameters registered 1 and 2 mo after treatment

Risk factor	P value1	P value2
Age	0.4275	0.4034
Sex	0.1147	0.4128
Duration of symptoms	0.4566	0.4018
Post-defecatory anal pain	0.6889	NA
Nocturnal anal pain	0.1008	0.1039
Anal pain unrelated to defecation	0.1507	0.1039
Bleeding	0.4669	0.1585
Mucorrhea	0.5826	0.2081
Other anal pathologies	0.1656	0.1591
Extra-anal associated pathologies	0.3223	0.133
Defecation pattern	0.3825	0.3972
Stool consistency	0.3825	0.3291
Number of evacuations/wk	0.1656	0.4197
Straining	0.2244	0.2615
Sensation of incomplete evacuation	0.2244	0.7323
Laxative use	0.2244	0.2615
Enemas/ suppositories use	0.2244	0.7323
Botulinum toxin dose	0.8151	0.1635
Resting anal tone	0.6889	NA
Maximal voluntary anal squeeze	0.2094	0.6179
Puborectal muscle relaxation	0.3111	NA
MVAS 0 (mmHg)	0.2457	0.7281
MVAS 1 (mmHg)	0.5292	0.4133
MVAS 2	NA	0.8272
RAP 0 (mmHg)	0.284	0.1322
RAP 1 (mmHg)	0.3513	0.0985
RAP 2	NA	0.172
Site of injection	0.0818	0.5815

MVAS 0: Maximal voluntary anal squeeze (pretreatment); MVAS 1: Maximal voluntary anal squeeze (1 mo after the treatment); MVAS 2: Maximal voluntary anal squeeze (2 mo after the treatment); RAP 0: Resting anal pressure (pretreatment); RAP 1: Resting anal pressure (1 mo after treatment); RAP 2: Resting anal pressure (2 mo after treatment). NA: Not applicable. 1: 1 mo after treatment; 2: 2 mo after treatment.

Table 5 Multivariate analysis of parameters registered 1 mo after treatment

Risk factor	P value	T ratio	95% CI
Age	0.8286	0.2183	-0.02207 to 0.01780
Sex	0.4231	0.8115	-0.2156 to 0.5011
MVAS 0	0.9669	0.04185	-0.01058 to 0.01102
Site of injection	0.7336	0.3433	-0.2783 to 0.3911
Maximal voluntary anal squeeze	0.3607	0.9273	-0.6433 to 0.2409
Enemas/suppositories use	0.5132	0.6612	-0.5860 to 1.149
Sensation of incomplete evacuations	0.7892	0.2696	-0.8144 to 1.063
Straining	0.8183	0.2317	-0.9509 to 1.195
Number of evacuations/wk	0.4590	0.7496	-0.03187 to 0.01473
Anal pain unrelated to evacuation	0.6136	0.5099	-1.341 to 0.8041
Nocturnal anal pain	0.5195	0.6513	-0.7694 to 1.492
Other anal pathologies	0.4454	0.7727	-0.3460 to 0.7686

MVAS 0: Maximal voluntary anal squeeze (pretreatment).

Table 6 Multivariate analysis of parameters registered 2 mo after treatment

Risk factor	P value	T Ratio	95% CI
Age	0.3091	1.059	-0.01680 to 0.005750
Sex	0.0111	2.957	0.1110 to 0.7129
Nocturnal pain	0.8100	0.2454	-0.3677 to 0.4619
Bleeding	0.2130	1.310	-0.4982 to 0.1221
Mucorrhea	0.3122	1.052	-0.6795 to 0.2345
Other anal pathologies	0.0712	1.965	-0.8284 to 0.03926
Extra-anal pathologies	0.2659	1.163	-0.4816 to 0.1446
Dose of botulinum toxin	0.0771	1.920	-0.02639 to 0.001555
RAP 0	0.0225	2.588	0.001689 to 0.01872
RAP 1	0.8975	0.1314	-0.008417 to 0.007451
RAP 2	< 0.0001	5.953	-0.03038 to -0.01420

RAP 0: Resting anal pressure (pretreatment); RAP 1: Resting anal pressure (1 mo after treatment); RAP 2: Resting anal pressure (2 mo after treatment).