Prospective evaluation of a new device for the treatment of anal fistulas

Table 1 Patients’ characteristics

Patient No.	Gender	Age (yr)	Fistula type	Fistula age (mo)	Aetiology	Symptoms	Previous fistula surgery	Smoking	Comorbidity
1	M	48	Transphincteric	2	Cryptoglandular	Drainage, smell	Setons	Yes	Hypertension
2	F	53	Transphincteric	21	Cryptoglandular	Drainage, smell	Setons	No	Thyroiditis, celiac disease
3	M	84	Extrasphincteric	9	Cryptoglandular	Drainage, pain	Setons	No	Hypertension, diabetes
4	M	48	Transphincteric	60	Cryptoglandular	Drainage, smell	Setons, fistulotomy	Yes	None
5	M	81	Extrasphincteric	8	Cryptoglandular	Drainage, pain	Setons	No	Hypertension
6	M	81	Transphincteric	36	Cryptoglandular	Drainage, pain	-	No	Atrial fibrillation
7	M	80	Transphincteric	9	Cryptoglandular	Drainage, smell	Setons	No	Hypertension, atrial fibrillation
8	F	34	Transphincteric	6	Cryptoglandular	Drainage, smell	Setons	No	None
9	F	71	Transphincteric	12	Cryptoglandular	Drainage, smell	Setons	No	COPD, Hypothyroidism
10	M	58	Transphincteric	36	Cryptoglandular	Drainage, smell	Setons, flap, plugs	No	Gastritis

Table 2 Intra-operative details

Patient No.	Device type	Distance from the a.v. (cm)	Length of the fistula tract (cm)	Internal opening, n	Fistula tracts, n	External opening, n	Size of external opening (cm)	Brushing of the tract	Irrigation of the tract
1	M2	2.0	3.5	1	1	1	0.1	Endoscopic brush, curette	H2O2, antibiotic
2	M2	2.0	3.0	1	1	2	0.1	Endoscopic brush, curette	H2O2, antibiotic
3	M2	5.0	10.0	1	2	2	0.2	Endoscopic brush, curette	H2O2, antibiotic
4	M1	1.5	3.0	1	2	2	0.1	Endoscopic brush, curette	H2O2, antibiotic
5	M2	5.0	7.5	1	2	2	0.2	Endoscopic brush, curette	H2O2, antibiotic
6	M1	2.0	4.0	1	1	1	0.1	Endoscopic brush, curette	H2O2, antibiotic
7	M2	1.5	2.5	1	1	1	0.5	Gauze, curette	H2O2, antibiotic
8	M2	1.5	3.0	1	1	1	0.2	Endoscopic brush, curette	H2O2, antibiotic
9	M1	2.0	3.0	1	1	1	0.5	Endoscopic brush, curette	H2O2, antibiotic
10	M2	2.0	4.0	1	1	1	1.5	Curette, Bovie	H2O2, antibiotic

Table 3 Results

Patient No.	1-wk follow up	2-wk follow up	1-mo follow up	2-mo follow up	3-mo follow up	6-mo follow up
1	Slight fever (TC 37.2 °C), serum discharge	Slight fever (TC 37.0 °C), serum discharge	Low serum discharge, disk removal	Persistence of inflammation	-	Failure
2	Low serum discharge	Low serum discharge	Low serum discharge, disk absent	Healing	Healing	Success
3	Low serum discharge	Low serum discharge	Low serum discharge, disk absent	Healing	Healing	Success
4	Serum discharge	Low serum discharge	Low serum discharge, disk absent	Healing	Healing	Success
5	Serum discharge, slight pain	Serum discharge, no pain	Low serum discharge, disk absent	Low serum discharge	Healing	Success
6	Serum discharge, slight pain	Low serum discharge, disk expulsion, no pain	Serum discharge	Low serum discharge	Healing	Success
7	Low serum discharge	Low serum discharge	Low serum discharge, disk absent	Healing	Healing	Success
8	Low serum discharge	Low serum discharge	Low serum discharge, disk absent	Low serum discharge	Low serum discharge	Failure
9	Low serum discharge	Low serum discharge	Low serum discharge, disk absent	Healing	Healing	Success
10	Low serum discharge	Device extrusion	-	-	-	Failure