Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn’s perianal fistulas

doi:10.4240/wjgs.v15.i11.2537

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Nov 27, 2023 (publication date) through Jan 5, 2025

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World Journal of Gastrointestinal Surgery

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1948-9366

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

Observational Study

World J Gastrointest Surg. Nov 27, 2023; 15(11): 2537-2552
Published online Nov 27, 2023. doi: 10.4240/wjgs.v15.i11.2537

Table 1 Discrete choice experiment attributes and levels

Attribute	Level
Attribute	1	2	3	4
Postoperative discomfort	Low	Medium	High	-
Fistula healing: Proportion of patients who have fistula closure/fistula healing and minimal fluid collection in the fistula after treatment	48%	55%	60%	95%
Fecal incontinence: Proportion of patients who experienced fecal incontinence after treatment	0%	16%	20%	34%
Recurrence: Proportion of patients with a return of symptoms related to anal fistula (discharge, pain, odor) after treatment	15%	25%	35%	60%
Rehabilitation time: Time taken to resume normal daily activities	Up to 1 wk	More than 1 wk, up to 4 wk	-	-
Invasiveness: Does the treatment involve cutting or puncturing of the skin?	Yes, involves cutting or puncturing and insertion of surgical instruments into the anal area	Yes, involves minimal cutting or puncturing and an injection of the treatment into the anal area	-	-

Table 2 Baseline demographics and patient characteristics

	Cohort 1	Cohort 2	Cohort 3	Cohorts 2 + 3
	All non-PF CD (n = 620)	CPF no surgery (n = 174)	CPF with surgery (n = 135)	All CPF (n = 309)
Sex, n (%)
Male	360 (58)^a	116 (67)^b	93 (69)^b	209 (68)^c
Age, yr, n (%)¹
21-40	340 (55)^a^,^d^,^e	112 (64)^c	90 (67)^c	202 (65)^c
41-60	208 (34)^b	59 (34)^b	44 (33)^b	103 (33)^b
61-80	72 (12)^a^,^d^,^e	3 (2)^c	1 (1)^c	4 (1)^c
CD flare-up status, n (%)
Recent flare-up	270 (44)^a^,^e	85 (49)^e	87 (64)^c^,^d	172 (56)^c
Comorbidities, n (%)
Asthma	88 (14)^b	27 (16)^b	30 (22)^b	57 (18)^b
Obesity	87 (14)^b	31 (18)^b	22 (16)^b	53 (17)^b
Cardiovascular disease	33 (5)^a^,^e	13 (7)^b	17 (13)^c	30 (10)^c
COPD	17 (3)^e	4 (2)^d	11 (8)^c^,^d	15 (5)^b
Cancer	22 (4)^b	7 (4)^b	7 (5)^b	14 (5)^b
Renal disease	14 (2)^b	6 (3)^b	6 (4)^b	12 (4)^b

^aP < 0.05 vs cohort 2 and 3 combined.

^bNo statistically significant difference versus any other cohort.

^cP < 0.05 vs cohort 1.

^dP < 0.05 vs cohort 2.

^eP < 0.05 vs cohort 3.

¹None of the patients were aged < 21 or > 80 yr.

Table 3 Disease presentation and symptom severity

	Cohort 1	Cohort 2	Cohort 3	Cohorts 2 + 3
	All non-PF CD (n = 620)	CPF no surgery (n = 174)	CPF with surgery (n = 135)	All CPF (n = 309)
Ever experienced fecal incontinence, n (%)	251 (40)^a^,^b^,^c	103 (59)^d	80 (59)^d	183 (59)^d
More than 5 CD complications, n (%)	266 (43)^a^,^b^,^c	135 (78)^d	111 (82)^d	246 (80)^d
PF experience
Number of unique PFs (mean ± SD)	NA	2.3 (1.4)^b	3.0 (3.0)^a	NA
Experience with PF recurrence/persistence, n (%)	NA	84 (48)^e	80 (59)^e	NA
CD severity (physician classified) at diagnosis, n (%)
Mild	187 (30)^a^,^b^,^c	24 (14)^d	23 (17)^d	47 (15)^d
Moderate	298 (48)^a^,^b^,^c	123 (71)^b^,^d	78 (58)^a^,^d	201 (65)^d
Severe	86 (14)^b	22 (13)^b	31 (23)^a^,^d	53 (17)^e
Not sure	49 (8)^a^,^b^,^c	5 (3)^d	3 (2)^d	8 (3)^d

^aP < 0.05 vs cohort 2.

^bP < 0.05 vs cohort 3.

^cP < 0.05 vs cohort 2 and 3 combined.

^dP < 0.05 vs cohort 1.

^eNo statistically significant difference versus any other cohort.

P values are shown where there is a statistically significant difference between specified cohorts. Bonferroni adjustment was applied when comparing more than 2 groups at P < 0.05. CD complications include reported frequency of intestinal obstructions, perianal abscesses, fissures, malabsorption and malnutrition, diarrhea, small intestinal bacterial overgrowth, megacolon, perforation of the intestine, colovesical fistulas, coloenteric fistulas, rectovaginal fistulas, multiple fistulas, anorectal strictures, fistulas in the upper part of the sphincter complex, enterocutaneous fistulas, ulcer, severe bleeding, intestinal strictures neoplasm, and “other”. CD: Crohn’s disease; CPF: Crohn’s perianal fistulas; NA: Not applicable; PF: Perianal fistulas.

Table 4 Medication and surgical experience

	Cohort 1	Cohort 2	Cohort 3	Cohorts 2 + 3
	All non-PF CD (n = 620)	CPF no surgery (n = 174)	CPF with surgery (n = 135)	All CPF (n = 309)
CD-related medication experience, n (%)
Currently taking	429 (69)^a^,^b^,^c	147 (84)^d	108 (80)^d	255 (83)^d
Previously taken	155 (25)^a^,^b^,^c	27 (16)^d	22 (16)^d	49 (16)^d
Never taken	36 (6)^a^,^c	0^b^,^d	5 (4)^a	5 (2)^d
CD-related surgical experience
Frequency of surgical experience ever, n (%)	190 (31)^a^,^b^,^c	78 (45)^b^,^d	119 (88)^a^,^d	197 (64)^d
Number of surgeries in the past 12 mo (mean ± SD)	1.5 (0.9)^b^,^c	1.8 (1.1)^b	2.2 (1.3)^a^,^d	2.0 (1.3)^d
Number of surgeries in the past 12 mo (median)	1^e	1^e	2^e	2^e
Frequency of surgical failure ever, n (%)	52 (27)^b^,^c	22 (28)^b	55 (46)^a^,^d	77 (39)^d
Number of failed surgeries ever (mean ± SD)	1.7 (2.1)^e	2.2 (1.6)^e	1.9 (1.8)^e	2.0 (1.7)^e
Number of failed surgeries ever (median)	1^e	2^e	1^e	1^e
PF-related surgical care
PF-related procedure or surgery frequency (mean ± SD)	NA	NA	5.6 (3.5)^e	NA
One PF-related procedure or surgery	NA	NA	9 (7)^e	NA
Two PF-related procedures or surgeries	NA	NA	21 (16)^e	NA
Three or more PF-related procedures or surgeries	NA	NA	105 (78)^e	NA
Failure of PF-related procedure or surgical care (at any time) ever, n (%)
One failed PF-related procedure or surgery	NA	NA	35 (26)^e	NA
Two or more failed PF-related procedure or surgery	NA	NA	19 (14)^e	NA

^aP < 0.05 vs cohort 2.

^bP < 0.05 vs cohort 3.

^cP < 0.05 vs cohort 2 + 3 combined.

^dP < 0.05 vs cohort 1.

^eNo statistically significant difference versus any other cohort.

Table 5 Satisfaction with perianal fistula treatments

	Cohort 2	Cohort 3
	CPF no surgery (n = 174)	CPF with surgery (n = 135)
Satisfaction with PF treatments (on a scale of 1-9), mean ± SD, % rated ≥ 7
Medication	6.5 (1.4), 57^a	6.4 (1.5), 50^a
Long-term seton placement	6.7 (1.5), 57^b	6.2 (1.7), 47^c
Endorectal/anal advancement flap	6.2 (1.7), 52^a	6.3 (1.7), 52^a
Fibrin glue	6.4 (1.9), 61^a	6.2 (1.6), 45^a
Anal fistula plug	6.6 (1.8), 66^a	6.5 (1.6), 56^a
Fistulectomy/fistulotomy	6.9 (1.6), 68^a	6.3 (1.9), 50^a
LIFT (ligation of intersphincteric fistula tract)	6.7 (1.5), 65^a	6.2 (1.7), 46^a
Satisfaction with PF treatment attributes (on a scale of 1-9), mean ± SD, % rated ≥ 7
Aids in closure of external opening of the fistulas	6.4 (1.5), 48^a	6.5 (1.6), 55^a
Reduction or no drainage	6.4 (1.6), 54^a	6.4 (1.6), 51^a
Time required for symptom improvement	6.3 (1.6), 54^a	6.3 (1.7), 50^a
Time required for rehabilitation	6.2 (1.7), 51^a	6.2 (1.8), 52^a
Length of duration before symptom(s) recur	6.3 (1.7), 52^a	6.3 (1.8), 52^a
Has minimal side effects (local pain, redness, itchiness)	6.2 (1.9), 54^a	6.3 (1.8), 53^a
Minimal risk of fecal incontinence	6.3 (1.7), 51^a	6.4 (1.7), 53^a
Not requiring a long-term seton placement	6.4 (1.7), 52^a	6.6 (1.7), 59^a
Less invasive nature of treatment (not requiring incision)	6.4 (1.7), 56^a	6.3 (1.8), 48^a

^aNo statistically significant difference versus the other cohort.

^bP < 0.05 vs cohort 3.

^cP < 0.05 vs cohort 2.

On a scale of 1-9, a higher number indicates a greater satisfaction. P values are shown where there is a statistically significant difference between specified cohorts. Bonferroni adjustment was applied when comparing more than 2 groups at P < 0.05. CPF: Crohn’s perianal fistulas; PF: Perianal fistulas.

Citation: Karki C, Athavale A, Abilash V, Hantsbarger G, Geransar P, Lee K, Milicevic S, Perovic M, Raven L, Sajak-Szczerba M, Silber A, Yoon A, Tozer P. Multi-national observational study to assess quality of life and treatment preferences in patients with Crohn’s perianal fistulas. World J Gastrointest Surg 2023; 15(11): 2537-2552
URL: https://www.wjgnet.com/1948-9366/full/v15/i11/2537.htm
DOI: https://dx.doi.org/10.4240/wjgs.v15.i11.2537