Effectiveness of Prokinetic Agents in Improving Abdominal Discomfort at Colonoscopy

Summary

colonoscopy has been a preferred modality for colorectal screening which efficiently reduce in morbidity and mortality of the disaese. Although colonoscopy is a safe procedure, some patients may be suffered from major and minor complications. Abdominal discomfort (approximately 30%) usually persisted for 2 days after colonoscopy. These unsatisfactory experiences might affect the patients' willingness to return for a repeat colonoscopy, which the loss of adherence eventually reduce the effectiveness of colorectal cancer screening and surveillance.

Furthermore, during colonoscopy preparation, the patients are required to take large volume Polyethylene glycol-electrolyte lavage (PEG-EL) solution for bowel preparation which possibly lead to unpleasant gastrointestinal symptoms likewise.

Prokinetic agents are a class of drugs that promoted gastrointestinal motility and, thereby, decrease transit time. This stimulatory effect was considered clinically relevant to the management of disorders characterized by impaired motility, such as gastro-esophageal reflux, gastroparesis, intestinal pseudo-obstruction, and colonic inertia. Prokinetic agents have various mechanism such as Cholinergic agonists, Dopamine antagonists (i.e.Domperidone, Metoclopramide), Serotonergic agonists (i.e. Cisapride, Prucalopride,Mosapride). Interestingly, these drugs have been used to minimize the unpleasant abdominal symptoms from colonoscopy.

The objective of this study is to examine the efficacy of a prokinetic agent in alleviating abdominal discomfort during the period of colonoscopy preparation and aftercolonoscopy consecutively.

Conditions

• Abdominal Pain

Interventions

DRUG

Itopride

the patients are instructed to take one pill of Itopride at 8.00 AM, 12.00 AM, 4.30 PM respectively before the dat of colonoscopy. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy.

DRUG

Domperidone

the patients are instructed to take one pill of Domperidone at 8.00 AM, 12.00 AM, 4.30 PM respectively before the dat of colonoscopy. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy.

OTHER

Placebo

the patients are instructed to take one pill of placebo at 8.00 AM, 12.00 AM, 4.30 PM respectively before the dat of colonoscopy. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy.

Sponsors & Collaborators

• Mahidol University

  lead OTHER

Principal Investigators

• Chairat Supsamutchai, MD · Ramathibodi Hospital

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-16

Primary Completion

2022-10-30

Completion

2023-02-01

Countries

• Thailand

Study Locations