Perianal fistulodesis – A pilot study of a novel minimally invasive surgical and medical approach for closure of perianal fistulae

Table 1 Comparison of clinical and epidemiological characteristics of patient cohorts

Characteristics	Non-IBD patients, n = 17	Patients with CD, n = 3	P value
Female: n (%); Male: n (%)	8 (47%); 9 (53%)	2 (66%); 1 (33%)	> 0.9999 (NS)
BMI (kg/m2), median (IQR), range	26 (21-30); Range: 20-38	23 (20h28); Range: 20-28	0.5632 (NS)
Age (yr), median (IQR), range	45 (39-52.2); Range: 32-76	34 (25-52); Range: 25-52	0.3114 (NS)
Smokers: n (%); Pack years; median (IQR), range	4 (24%)1; 0 (0-12.5)2; Range: 0-30	1 (33%); 0.25 (0-10); Range: 0-10	0.3333 (NS); 0.7911 (NS)
Years from fistula onset until fistulodesis median (IQR), range	1 (0-2); Range: 0-12	3 (2-7); Range: 2-7	0.0386
Previous fistula operations median (IQR), range	1 (1-3); Range: 0-10	4 (2-8); Range: 2-8	0.1219 (NS)
IBD-Q score at screening median (IQR), range	167.5 (144.5-199.3)3; Range: 110.5-217	215.5 (213-218)4; Range: 213-218	0.0333
PDAI at screening median (IQR), range	6 (5-8); Range: 3-141	5 (4-7); Range: 4-7	0.4334 (NS)
HBI at screening median (IQR), range	Not determined	0 (0-2); Range: 0-2
Pre-operative local pain median (IQR), range	1 (1-2.8); Range: 0-101	2 (1-5); Range: 1-5	0.4964 (NS)
Pre-operative secretions median (IQR), range	4 (3-5); Range: 0-51	4 (4-5); Range: 4-5	0.8720 (NS)
Distance outer lumen to dentate line (cm) median (IQR), range	2 (1.4-3.1); Range: 1-41	1 (1-2); Range: 1-2	0.1714 (NS)
Distance inner lumen to dentate line (cm) median (IQR), range	0 (0-0.5); Range: 0-21	0.5 (0-1.5); Range: 0-1.5	0.3842 (NS)
Length of fistula tract (cm) median (IQR), range	3.8 (2.7-4.9); Range: 1.5-61	2.5 (2-5); Range: 2-5	0.5549 (NS)
Sphincter involvement (%) mean (IQR), range	50 (40-68.3); Range: 25-801	55 (20-90); Range: 20-90	> 0.9999 (NS)
Fistula closure 24 wk after fistulodesis; n (%)	5 (26%)5	2 (66%)	0.3333 (NS)

¹Data not available for 1 non-inflammatory bowel disease (IBD) patient.

²Data not available of 4 non-IBD patients.

³IBD-Q at screening of 3 non-IBD patients not available.

⁴IBD-Q at screening of on 1 CD patient was available.

⁵From a total of 19 operated fistulae in 17 non-IBD patients. Statistical analysis was performed using the Mann-Whitney and Fisher’s exact test.

BMI: Body-Mass-Index; IQR: Interquartile range; IBD-Q: Inflammatory bowel disease questionnaire; PDAI: Perianal disease activity index; HBI: Harvey-Bradshaw Index; NS: Not significant.

Table 2 Adverse effects of fistulodesis

Side effects of treatment	Non-IBD patients, n = 17	Patients with CD, n = 3	Related to study procedures
Fistula recurrence	13	1	Yes
New fistula (at a separate site from initial fistula)	0	1	Unlikely
Perianal abscess (at a separate site from initial fistula)	1	0	Unlikely
Anemia	1	0	Highly unlikely
Anal fissure	x	x	Possible

non-IBD: Non-inflammatory bowel disease; CD: Crohn’s disease.