Bowel Preparation for Colonoscopy in the Elderly

Colonoscopy Clinical Trial

Official title:

Bowel Preparation With Standard 4 Liters of PEG vs. Split-dose of 4 Liters PEG vs. Split-dose of 2 Liters PEG Containing Ascorbic Acid Solutions for Outpatient Elective Colonoscopy in the Elderly: A Randomized, Colonoscopist-blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290093
• Other study ID #: 4LPEG-2LPEGA-Elderly-2014
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2014
• Last updated: February 22, 2016
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

The success of colonoscopy is closely related to the quality of colonic preparation. However, data regarding colonoscopy preparations in the elderly (65 years older) are scarce. Split-dosage cathartic bowel preparation are currently suggested, whereas supporting evidence is lacking in this particular group of patients. Moreover, patient tolerability is a key factor for success of bowel preparation in the aged people.

The purpose of this study is to compare the bowel cleansing efficacy and patient compliance of following bowel preparation methods prior to elective outpatient colonoscopy in the elderly: (1) standard preparation of 4 liters (L) PEG-3350 solution on the night before colonoscopy, (2) split-dose of 4L PEG-3350 solution, and (3) split-dose of reduced volume [2L] PEG-3350 containing ascorbic acid solution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• elderly people aged over 65 years

• elective outpatient colonoscopy

• informed consent

Exclusion Criteria:

• patients who had bowel movements of less than 3 per week during last one month

• patients who have a history of renal dysfunction (abnormal elevation of serum creatinine and electrolyte imbalance)

• patients who have a history of alimentary tract surgery

• patients who have other gastrointestinal diseases that are not suitable for undergoing colonoscopy (gastroparesis, gastric outlet obstruction, ileus, ischemic colitis, megacolon, and toxic colitis)

• patients classified as the American Society for Anesthesiology class III or higher

• Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy

Intervention

Drug:
• Standard full-volume PEG
Subjects will be asked to take 4L of PEG-3350 solution the day prior to procedure.
• Split-dose full-volume PEG
Subjects will be asked to take 2L of PEG-3350 solution the day prior to procedure, followed by another 2L of PEG-3350 solution on the day of the procedure.
• Split-dose low-volume PEG
Subjects will be asked to take 1L of PEG-3350 containing ascorbic acid solution the day prior to procedure, followed by another 1L of PEG-3350 containing ascorbic acid solution on the day of the procedure.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Guri Hospital	Guri
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Hanyang University, Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

ASGE Standards of Practice Committee, Chandrasekhara V, Early DS, Acosta RD, Chathadi KV, Decker GA, Evans JA, Fanelli RD, Fisher DA, Foley KQ, Fonkalsrud L, Hwang JH, Jue T, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf R, Shergill AK, Cash BD. Modifications in endoscopic practice for the elderly. Gastrointest Endosc. 2013 Jul;78(1):1-7. doi: 10.1016/j.gie.2013.04.161. Epub 2013 May 9. Review. Erratum in: Gastrointest Endosc. 2013 Sep;78(3):559. — View Citation

Cohen LB. Split dosing of bowel preparations for colonoscopy: an analysis of its efficacy, safety, and tolerability. Gastrointest Endosc. 2010 Aug;72(2):406-12. doi: 10.1016/j.gie.2010.04.001. Epub 2010 Jul 1. Review. — View Citation

Ell C, Fischbach W, Bronisch HJ, Dertinger S, Layer P, Rünzi M, Schneider T, Kachel G, Grüger J, Köllinger M, Nagell W, Goerg KJ, Wanitschke R, Gruss HJ. Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing be — View Citation

Téllez-Ávila FI, Murcio-Pérez E, Saúl A, Herrera-Gómez S, Valdovinos-Andraca F, Acosta-Nava V, Barreto R, Elizondo-Rivera J. Efficacy and tolerability of low-volume (2 L) versus single- (4 L) versus split-dose (2 L + 2 L) polyethylene glycol bowel prepara — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of adequate bowel preparation quality at the time of colonoscopy defined by the Boston bowel preparation scale (BBPS).	The BBPS assesses cleanliness of 3 segments of the colon (ascending, transverse, and descending colon), and the total is a 10-point scale (0-9) that grades each segment of the colon from 0 to 3. In this study, adequate bowel preparation is defined as a total score 6 points or higher and individual score of 2 points or higher in each segment.	1 year	No
Secondary	Patient satisfaction with recommended bowel preparation method based on the 10-point visual analog scale		1 year	No
Secondary	Rate of adverse events related to bowel preparation for colonoscopy	Adverse events include tenesmus, sleep disturbance, nausea, vomiting, abdominal cramping, abdominal fullness, abdominal discomfort, headache, dizziness, and others.	1 year	Yes
Secondary	Number of patients who have a willingness to repeat same bowel preparation method method		1 year	No
Secondary	Consumed volume of recommended bowel preparation agent based on the 3-grade scale	The 3-grade scale: optimal (100%), good (= 75%), and poor (< 75%)	1 year	No
Secondary	Difficulty of completing ingestion of recommended bowel preparation agent based on the 3-grade scale	The 3-grade scale: never, some, and much	1 year	No
Secondary	Taste of recommended bowel preparation agent based on the 3-grade scale	The 3-grade scale: bad, neutral, and good	1 year	No