Wireless pH-motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation.
BACKGROUND
Colon transit (CT) measurements are used in the management of significant constipation. The radiopaque marker (ROM) method provides limited information.


METHODS
We proposed to validate wireless motility capsule (WMC), that measures pH, pressure and temperature, to ROM measurement of CT in patients with symptomatic constipation evaluated at multiple centers. Of 208 patients recruited, 158 eligible patients underwent simultaneous measurement of colonic transit time (CTT) using ROM (Metcalf method, cut off for delay >67 h), and WMC (cutoff for delay >59 h). The study was designed to demonstrate substantial equivalence, defined as diagnostic agreement >65% for patients who had normal or delayed ROM transit.


RESULTS
Fifty-nine of 157 patients had delayed ROM CT. Transit results by the two methods differed: ROM median 55.0 h [IQR 31.0-85.0] and WMC (43.5 h [21.7-70.3], P < 0.001. The positive percent agreement between WMC and ROM for delayed transit was approximately 80%; positive agreement in 47 by WMC/59 by ROM or 0.796 (95% CI = 0.67-0.98); agreement vs null hypothesis (65%) P = 0.01. The negative percent agreement (normal transit) was approximately 91%: 89 by WMC/98 by ROM or 0.908 (95% CI = 0.83-0.96); agreement vs null hypothesis (65%), P = 0.00001. Overall device agreement was 87%. There were significant correlations (P < 0.001) between ROM and WMC transit (CTT [r = 0.707] and between ROM and combined small and large bowel transit [r = 0.704]). There were no significant adverse events.


CONCLUSIONS
The 87% overall agreement (positive and negative) validates WMC relative to ROM in differentiating slow vs normal CT in a multicenter clinical study of constipation.
Camilleri
M
M
College of Medicine, Mayo Clinic, Rochester, MN, USA. camilleri.michael@mayo.edu
Thorne
N K
NK
Ringel
Y
Y
Hasler
W L
WL
Kuo
B
B
Esfandyari
T
T
Gupta
A
A
Scott
S M
SM
McCallum
R W
RW
Parkman
H P
HP
Soffer
E
E
Wilding
G E
GE
Semler
J R
JR
Rao
S S C
SS
D000328:Adult; D053704:Capsule Endoscopy / Q000379:methods*; D002214:Capsules; D002908:Chronic Disease; D003106:Colon / Q000503:physiopathology*; D003248:Constipation / Q000175:diagnosis / Q000503:physiopathology; D003287:Contrast Media / Q000378:metabolism*; D005260:Female; D005772:Gastrointestinal Transit / Q000502:physiology*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results
D002214:Capsules; D003287:Contrast Media
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