I C Lawrance1, R P Willert, K Murray. 1. Centre for Inflammatory Bowel Diseases, Fremantle Hospital, Fremantle, WA, Australia. ian.lawrance@uwa.edu.au
Abstract
BACKGROUND AND STUDY AIMS: Bowel-cleansing studies are frequently underpowered, poorly designed, and with subjective assessments. Consensus on tolerability of the bowel-cleansing agents is thus lacking. This study developed and validated a bowel-preparation tolerability questionnaire and used it to assess the tolerability of three bowel-cleansing agents, sodium phosphate (NaP), polyethylene glycol (PEG), and sodium picosulphate (Pico), in a prospective randomized single-blinded trial of ambulatory patients. PATIENTS AND METHODS: The bowel-preparation tolerability questionnaire was validated in 125 consecutive patients and then bowel-preparation agent tolerability was assessed in 634 patients in a prospective randomized single-blinded trial. RESULTS: The questionnaire's internal consistency was satisfactory with good to excellent "test-retest" reliability for aggregate tolerability and visual analogue scores. Validity assessment confirmed it as reliable and accurate. Of 634 patients, 97.8 % took >75 % of the allocated preparation and 98.9 % completed the questionnaire. Overall, Pico was better tolerated than PEG (p < 0.001) and NaP (p < 0.001). NaP was better tolerated than PEG (p < 0.001). Regardless of the bowel-preparation agent used, males tolerated them better than females (p = 0.009) as did patients having their procedure in the AM. Older patients, however, tolerated all preparations better than younger patients (p = 0.006). CONCLUSIONS: This study used the first validated bowel-preparation tolerability questionnaire and identified that age, sex, and procedure time all impacted tolerability. Overall, Pico was best tolerated, but PEG's tolerability in patients ≥60 years was equal to that of Pico and NaP, suggesting that PEG can be recommended for older patients to avoid the electrolyte disturbances associated with the osmotic preparations.
RCT Entities:
BACKGROUND AND STUDY AIMS: Bowel-cleansing studies are frequently underpowered, poorly designed, and with subjective assessments. Consensus on tolerability of the bowel-cleansing agents is thus lacking. This study developed and validated a bowel-preparation tolerability questionnaire and used it to assess the tolerability of three bowel-cleansing agents, sodium phosphate (NaP), polyethylene glycol (PEG), and sodium picosulphate (Pico), in a prospective randomized single-blinded trial of ambulatory patients. PATIENTS AND METHODS: The bowel-preparation tolerability questionnaire was validated in 125 consecutive patients and then bowel-preparation agent tolerability was assessed in 634 patients in a prospective randomized single-blinded trial. RESULTS: The questionnaire's internal consistency was satisfactory with good to excellent "test-retest" reliability for aggregate tolerability and visual analogue scores. Validity assessment confirmed it as reliable and accurate. Of 634 patients, 97.8 % took >75 % of the allocated preparation and 98.9 % completed the questionnaire. Overall, Pico was better tolerated than PEG (p < 0.001) and NaP (p < 0.001). NaP was better tolerated than PEG (p < 0.001). Regardless of the bowel-preparation agent used, males tolerated them better than females (p = 0.009) as did patients having their procedure in the AM. Older patients, however, tolerated all preparations better than younger patients (p = 0.006). CONCLUSIONS: This study used the first validated bowel-preparation tolerability questionnaire and identified that age, sex, and procedure time all impacted tolerability. Overall, Pico was best tolerated, but PEG's tolerability in patients ≥60 years was equal to that of Pico and NaP, suggesting that PEG can be recommended for older patients to avoid the electrolyte disturbances associated with the osmotic preparations.
Authors: Christian Ell; Wolfgang Fischbach; Hans-Joachim Bronisch; Stefan Dertinger; Peter Layer; Michael Rünzi; Thomas Schneider; Günther Kachel; Jörg Grüger; Michael Köllinger; Waltraud Nagell; Karl-Josel Goerg; Roland Wanitschke; Hans-Jürgen Gruss Journal: Am J Gastroenterol Date: 2008-01-11 Impact factor: 10.864
Authors: Michael Sai Lai Sey; Daniel von Renteln; Richard Sultanian; Cassandra McDonald; Myriam Martel; Alan Barkun Journal: BMJ Open Date: 2019-07-09 Impact factor: 2.692
Authors: Dale R Bachwich; James D Lewis; Vera O Kowal; Brian C Jacobson; Audrey H Calderwood; Michael L Kochman Journal: Clin Transl Gastroenterol Date: 2020-12 Impact factor: 4.396
Authors: Gabriel Perreault; Adam Goodman; Sebastian Larion; Ahana Sen; Kirsten Quiles; Michael Poles; Renee Williams Journal: Ann Gastroenterol Date: 2018-03-28
Authors: Jaroslaw Regula; Manon C W Spaander; Stepan Suchanek; Anne Kornowski; Valerie Perrot; Wolfgang Fischbach Journal: Endosc Int Open Date: 2020-02-21