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Table 1 Base-line characteristics of patients with FAP

From: Ursodeoxycholic acid counteracts celecoxib in reduction of duodenal polyps in patients with familial adenomatous polyposis: a multicentre, randomized controlled trial

 

Overall population

Group A:

Celecoxib&UDCA

Group B:

Celecoxib&Placebo

p value

Number of patients

37

19

18

 

Age at study entry, median/range (yr)

42/22–67

42/22–67

41/27–64

0.9641

Sex (n, %)

   

0.6182

  Male

18 (48.6)

10 (52.6)

8 (44.4)

 

  Female

19 (51.4)

9 (47.4)

10 (55.6)

 

Participants per centre (n, %)

   

0.9323

  RUNMC

18 (48.6)

10 (52.6)

8 (44.4)

 

  AMC

10 (27.0)

4 (21.1)

6 (33.3)

 

  EMC

4 (10.8)

2 (10.5)

2 (11.1)

 

  UMCG

3 (8.1)

2 (10.5)

1 (5.6)

 

  LUMC

2 (5.4)

1 (5.3)

1 (5.6)

 

Body Mass Index, median/range (kg/m2)

25.6/18.8–34.5

26.0/19.2–34.5

25.6/18.8–33.1

0.4081

Diagnosis FAP

   

0.6603

  Clinical only

6 (16.2)

4 (21.2)

2 (11.1)

 

  APC gene mutation

31 (83.8)

15 (78.9)

16 (88.9)

 

Age at primary CR surgery, median/range (yr)

21/7–60

22/7–60

18.5/11–48

0.2981

Time since primary CR surgery, median/range (yr)

18/1–38

17/1–33

20.5/8–38

0.1781

Type of primary CR surgery

   

0.7383

  IRA

18 (48.6)*

10 (52.6)*

8 (44.4)

 

  IPAA

14 (37.8)

6 (31.6)

8 (44.4)

 

  Ileostomy

5 (13.5)

3 (15.8)

2 (11.1)

 

Secondary CR surgery (n, %)

11 (29.7)

5 (26.3)

6 (33.3)

0.6412

Spigelman stage at last surveillance before entry

   

0.9852

  II

19 (51.4)**

10 (52.6)

9 (50)**

 

  III

17 (45.9)**

9 (47.4)

8 (44.4)**

 
  1. * Including one patient who underwent ileosigmoid anastomosis; ** In 1 case exact data on last previous surveillance duodenoscopy was missing; 1 The P value was calculated using the Mann–Whitney U test; 2 The P value was calculated using the chi-square test; 3 The P value was calculated using the Fisher’s exact test. FAP familial adenomatous polyposis, APC adenomatous polyposis coli, CR colorectal, IRA ileorectal anastomosism, IPAA ileal pouch-anal anastomosis; Ileostomy: proctocolectomy with ileostomy, UDCA ursodeoxycholic acid, AMC Academic Medical Centre Amsterdam, EMC Erasmus Medical Centre Rotterdam, LUMC Leiden University Medical Centre, RUNMC Radboud University Nijmegen Medical Centre, UMCG University Medical Centre Groningen.