Randomized controlled trial of minimally invasive surgery using acellular dermal matrix for complex anorectal fistula

Table 1 Demographic data about the patients included in this study

Characteristic	ADM (n = 45)	ERAF (n = 45)	P value
Gender (male/female)	24/21	25/20	NS
Age (SD, range)	18-59 (44.8)	17-61 (45.1)	NS
Smoking history, n (%)	14 (31)	11 (24)	NS
Course of disease (SD, range, mo)	3.0-7.1 (4.6)	2.8-6.9 (5.1)	NS
Type of fistula (intrasphincteric/transsphincteric)	19/26	17/28	NS
Median follow-up time	5.7 (5.1-6.4)	6.1 (5.9-6.5)	NS

ADM: Acellular dermal matrix; ERAF: Endorectal advancement flap; NS: Not significant.

Table 2 Vaizey score system

	Never	Rare	Sometimes	Each week	Everyday
Frequency of incontinence	0	1	2	3	4
Solid	0	1	2	3	4
Liquid	0	1	2	3	4
Gas	0	1	2	3	4
Alteration in lifestyle				No	Yes
Need to wear a pad or plug				0	2
Use of constipating medication				0	2
Lack of ability to defer defecation for 15 min				0	4

Table 3 Life quality scale system[16]

Physical

P1 It is difficult for me to get out and do things like going to a movie or to church

P2 I avoid travelling

P3 Whenever I am away from home, I try and stay near a toilet as much as possible

P4 I can’t hold on to my bowel motion long enough to get to the bathroom

P5 I try to prevent bowel accidents by staying very near a bathroom

P6 I cut down on how much I eat before I go out

P7 Whenever I go somewhere new, I make sure I know where the toilets are

Social

S1 I avoid visiting my friends

S2 I avoid staying the night away from home

S3 It is important to plan my daily activities around my bowel habit

S4 I leak stool without even noticing it

S5 I can’t do many things I want to do

S6 I have sex less often than I would like

S7 I feel different from other people

S8 I avoid travelling by plane or public transport

S9 I avoid going out to eat

S10 I am afraid to have sex

Emotional

E1 I am afraid to go out

E2 I worry about not being able to get to the toilet in time

E3 I feel unhealthy

E4 I feel ashamed

E5 I worry about bowel accidents

E6 I feel depressed

E7 I worry about the smell

E8 I enjoy life less

E9 The possibility of bowel accidents is always on my mind

E10 During the past month have you felt so sad, discouraged, hopeless, or had so many

Problems that you wondered whether anything was worthwhile?

Overall sense of well-being

In general, would you say your health is excellent/very good/good/fair/poor?

Table 4 Recurrence, fecal incontinence, anal deformity, postoperative pain time, and healing time of patients with ADM or ERAF n (%)

	ADM	ERAF	P value
n	45	45
Recurrence	2 (4.45)	13 (28.89)	0.0047
Fecal incontinence	1 (2.22)	4 (8.89)	0.3574
Anal deformity	0 (0)	3 (6.67)	0.2402
Postoperative pain time (d)	1.5 ± 0.5	7.5 ± 1.8	0.0000
Healing time (d)	7.5 ± 3.5	24.5 ± 5.5	0.0000

Table 5 Recurrence, fecal incontinence, anal deformity, postoperative pain time, and healing time of patients with intrasphincteric fistula, ADM or ERAF n (%)

	Intra ADM	Intra ERAF	P value
n	19	17
Recurrence	0 (0.00)	3 (17.65)	0.1907
Fecal incontinence	0 (0.00)	0 (0.00)
Anal deformity	0 (0.00)	0 (0.00)
Postoperative pain time (d)	1.2 ± 0.4	5.5 ± 1.9	0.0000
Healing time (d)	7.1 ± 3.4	24.6 ± 5.4	0.0000

Table 6 Recurrence, fecal incontinence, anal deformity, postoperative pain time, and healing time of patients with transsphincteric fistula, ADM or ERAF n (%)

	Trans ADM	Trans ERAF	P value
n	26	28
Recurrence	2 (7.69)	10 (35.71)	0.0318
Fecal incontinence	1 (3.85)	4 (14.29)	0.9390
Anal deformity	0 (0.00)	3 (10.71)	0.2615
Postoperative pain time (d)	1.5 ± 0.6	8.6 ± 1.4	0.0000
Healing time (d)	7.6 ± 3.6	25.9 ± 5.7	0.0000

Table 7 Life quality score in different groups

Group	n	Life quality score	P value
ADM	45	85.9 ± 5.3
Intra ADM	19	87.6 ± 6.5
Trans ADM	26	83.5 ± 5.7
ERAF	45	65.3 ± 8.9	0.0000
Intra ERAF	17	64.3 ± 5.1	0.00001
Trans ERAF	28	65.9 ± 7.8	0.00002

¹Represents comparison between intrasphincteric fistulae using ADM and ERAF;

²Represents comparison between transsphincteric fistulae using ADM and ERAF.

Table 8 Publications on anal fistula plug in the World

Author	Publication form	Total patients (n)	Crohn’s patients (n)	Follow-up median (mo)	Success rate (%)
Adamina et al[29], 2010	Article	12	0	12.6 (10-14)	50.0
Schwandner et al[30], 2009	Article	60	0	12	62.0
Schwandner et al[31], 2009	Article	36	0	9	75.0
Zubaidi et al[32], 2009	Article	23	0	12	83.0
Ortiz et al[33], 2009	Article	15	0	12	20.0
Chung W et al[34], 2009	Article	65	0	12	59.3
Wang et al[35], 2009	Article	29	0	18 (9.1-26.8)	34.0
Christoforidis et al[36], 2009	Article	37	4	14 (6-22)	32.0
Safar et al[37], 2009	Article	35	4	4	14.0
Christoforidis et al[38], 2008	Article	49	4	6.5	43.0
Song et al[39], 2008	Article	30	0	6.3	100.0
Ky et al[40], 2008	Article	45	14	6.5 (3-13)	84.0
Lawes et al[41], 2008	Article	20	0	7.4	24.0
Ellis[42], 2007	Article	17	5	6	88.0
van Koperen et al[43], 2007	Article	17	1	7	41.0
Ky et al[44], 2007	Abstract	37	8	3	84.0
Abbas et al[45], 2007	Abstract	17	0	7.4	24.0
Bohe et al[46], 2007	Abstract	32	7	6	65.0
Lenisa et al[47], 2007	Abstract	27	0	11	63.0
Thekkinkattil et al[48], 2007	Abstract	40	0	6	40.0
Poirier et al[49], 2006	Abstract	27	0	5	59.0
Champagne et al[50], 2006	Article	46	0	12	83.0