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Effectiveness of Prokinetic Agents in Improving Abdominal Discomfort at Colonoscopy

Primary Purpose

Abdominal Pain

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Itopride
Domperidone
Placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abdominal Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who are an outpatient scheduled for elective colonoscopy at Ramathibodi hospital
  • Age between 18 to 80 years old
  • American Society of Anesthesiologists (ASA) classification 1-2

Exclusion Criteria:

  • Patients who reject to participate or withdrawal from the research
  • History of Domperidone or Itopride allergy
  • Patients who do not complete taking the study medication
  • Patients who have ostomy or history of subtotal colectomy
  • Patients who are diagnosed active colitis i.e. ulcerative colitis, TB colitis
  • Take any pain reliever agent during the study period
  • Patients who are unable to communicate comprehensibly
  • Severe renal or hepatic impairment
  • Pregnancy

Sites / Locations

  • Chairat Supsamutchai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Colonoscopy preparation by PEG-EL with Itopride

Colonoscopy preparation by PEG-EL with Placebo

Colonoscopy preparation by PEG-EL with Domperidone

Arm Description

Regular protocol for colonoscopy preparation, no solid foods are allowed except low residue diet during three days before the procedure. On the next day, only liquid diet consumption is allowed.On the day prior to colonoscopy, the patients can have only clear liquid and ad libitum throughout the day until midnight. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours one day befor colonoscopy.

Regular protocol for colonoscopy preparation, no solid foods are allowed except low residue diet during three days before the procedure. On the next day, only liquid diet consumption is allowed.On the day prior to colonoscopy, the patients can have only clear liquid and ad libitum throughout the day until midnight. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours one day befor colonoscopy.

Regular protocol for colonoscopy preparation, no solid foods are allowed except low residue diet during three days before the procedure. On the next day, only liquid diet consumption is allowed.On the day prior to colonoscopy, the patients can have only clear liquid and ad libitum throughout the day until midnight. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours one day befor colonoscopy.

Outcomes

Primary Outcome Measures

abdominal pain
the severity of abdominal pain using a 4-point scale (1=absent, 2=mild, 3=moderate, 4=severe)

Secondary Outcome Measures

abdominal pain
the severity of abdominal pain using a 4-point scale (1=absent, 2=mild, 3=moderate, 4=severe)
abdominal pain
the severity of abdominal pain using a 4-point scale (1=absent, 2=mild, 3=moderate, 4=severe)

Full Information

First Posted
September 17, 2019
Last Updated
September 1, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04104867
Brief Title
Effectiveness of Prokinetic Agents in Improving Abdominal Discomfort at Colonoscopy
Official Title
A Randomized Controlled Double-blinded of Effectiveness of Prokinetic Agents in Improving Abdominal Discomfort at Pre- and Post- Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
The participants will be randomly selected into one of the three arms of this report's diagram (1:1:1 ratio) drawing of a sealed, opaque envelope by one of the surgical residents in charge or by the attending surgeon. The participants in each group will receive an envelope containing pills of identical appearance, each of Domperidone 10 mg, Itopride 50 mg or placebo. Both the attending physicians and the participants are blinded to the kind of study medication contained in the envelope. From the regular protocol for colonoscopy preparation, no solid foods are allowed except low residue diet during three days before the procedure. On the next day, only liquid diet consumption is allowed. On the day prior to colonoscopy, the patients can have only clear liquid and ad libitum throughout the day until midnight. Additionally, the patients are instructed to take one pill at 8.00 AM, 12.00 AM, 4.30 PM respectively. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy. At the colonoscopy unit, the patients will be interviewed regarding the severity of abdominal discomfort during the preparation period after consuming the 3 liters of PEG-EL using a 4-point scale (1=absent, 2=mild, 3=moderate, 4=severe). After finish the procedure, patients are informed to continue the study medication for three days consecutively. The interviewer will make a phone call to the individuals at the first and third day after the procedure to confirm compliance of the study medication and inquiry about the severity of abdominal discomfort after procedure by using the same 4-point scale. If the patient can't be reached by a phone call or fail to continue the medication, this patient is classified as a drop out. All data is collected by the main investigator from the patient chart and data recording form. Statistical analysis is performed using SPSS version 18. Patient characteristic and numerical data are reported by descriptive statistic such as mean, standard deviation. Parametric data is compared between groups using Chi-square, logistic regression analysis.Statistical significance is set at a level of p<0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants will be randomly selected into one of the three arms (1:1:1 ratio) of a sealed, opaque envelope by one of the surgical residents or by the attending surgeon. The participants in each group will receive an envelope containing pills of identical appearance, each of Domperidone 10 mg, Itopride 50 mg or placebo. Both the attending physicians and the participants are blinded to the kind of study medication contained in the envelope. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy. At the colonoscopy unit, the patients will be interviewed regarding the severity of abdominal discomfort during the preparation period after consuming the 3 liters of PEG-EL using a numeric pain rating scale.
Masking
Participant
Allocation
Randomized
Enrollment
525 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colonoscopy preparation by PEG-EL with Itopride
Arm Type
Active Comparator
Arm Description
Regular protocol for colonoscopy preparation, no solid foods are allowed except low residue diet during three days before the procedure. On the next day, only liquid diet consumption is allowed.On the day prior to colonoscopy, the patients can have only clear liquid and ad libitum throughout the day until midnight. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours one day befor colonoscopy.
Arm Title
Colonoscopy preparation by PEG-EL with Placebo
Arm Type
Placebo Comparator
Arm Description
Regular protocol for colonoscopy preparation, no solid foods are allowed except low residue diet during three days before the procedure. On the next day, only liquid diet consumption is allowed.On the day prior to colonoscopy, the patients can have only clear liquid and ad libitum throughout the day until midnight. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours one day befor colonoscopy.
Arm Title
Colonoscopy preparation by PEG-EL with Domperidone
Arm Type
Active Comparator
Arm Description
Regular protocol for colonoscopy preparation, no solid foods are allowed except low residue diet during three days before the procedure. On the next day, only liquid diet consumption is allowed.On the day prior to colonoscopy, the patients can have only clear liquid and ad libitum throughout the day until midnight. They are also informed to begin consuming the 3 liters of PEG-EL at 5.00 PM and complete it within 3 hours one day befor colonoscopy.
Intervention Type
Drug
Intervention Name(s)
Itopride
Other Intervention Name(s)
Colonoscopy preparation by PEG-EL with Itopride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Domperidone
Other Intervention Name(s)
Colonoscopy preparation by PEG-EL with Domperidone
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Colonoscopy preparation by PEG-EL with Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
abdominal pain
Description
the severity of abdominal pain using a 4-point scale (1=absent, 2=mild, 3=moderate, 4=severe)
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
abdominal pain
Description
the severity of abdominal pain using a 4-point scale (1=absent, 2=mild, 3=moderate, 4=severe)
Time Frame
48 hour
Title
abdominal pain
Description
the severity of abdominal pain using a 4-point scale (1=absent, 2=mild, 3=moderate, 4=severe)
Time Frame
72 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are an outpatient scheduled for elective colonoscopy at Ramathibodi hospital Age between 18 to 80 years old American Society of Anesthesiologists (ASA) classification 1-2 Exclusion Criteria: Patients who reject to participate or withdrawal from the research History of Domperidone or Itopride allergy Patients who do not complete taking the study medication Patients who have ostomy or history of subtotal colectomy Patients who are diagnosed active colitis i.e. ulcerative colitis, TB colitis Take any pain reliever agent during the study period Patients who are unable to communicate comprehensibly Severe renal or hepatic impairment Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chairat Supsamutchai, MD
Organizational Affiliation
Ramathibodi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chairat Supsamutchai
City
Bangkok
State/Province
Bankok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28887755
Citation
Quigley EMM. Prokinetics in the Management of Functional Gastrointestinal Disorders. Curr Gastroenterol Rep. 2017 Sep 8;19(10):53. doi: 10.1007/s11894-017-0593-6.
Results Reference
background
PubMed Identifier
19866393
Citation
Panteris V, Haringsma J, Kuipers EJ. Colonoscopy perforation rate, mechanisms and outcome: from diagnostic to therapeutic colonoscopy. Endoscopy. 2009 Nov;41(11):941-51. doi: 10.1055/s-0029-1215179. Epub 2009 Oct 28.
Results Reference
result
PubMed Identifier
22391645
Citation
de Jonge V, Sint Nicolaas J, van Baalen O, Brouwer JT, Stolk MF, Tang TJ, van Tilburg AJ, van Leerdam ME, Kuipers EJ; SCoPE consortium. The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. Am J Gastroenterol. 2012 Jun;107(6):878-84. doi: 10.1038/ajg.2012.40. Epub 2012 Mar 6.
Results Reference
result
PubMed Identifier
12118964
Citation
Pignone M, Saha S, Hoerger T, Mandelblatt J. Cost-effectiveness analyses of colorectal cancer screening: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2002 Jul 16;137(2):96-104. doi: 10.7326/0003-4819-137-2-200207160-00007.
Results Reference
result
PubMed Identifier
18577886
Citation
Mishima Y, Amano Y, Okita K, Takahashi Y, Moriyama N, Ishimura N, Furuta K, Ishihara S, Adachi K, Kinoshita Y. Efficacy of prokinetic agents in improving bowel preparation for colonoscopy. Digestion. 2008;77(3-4):166-72. doi: 10.1159/000141040. Epub 2008 Jun 25.
Results Reference
result

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Effectiveness of Prokinetic Agents in Improving Abdominal Discomfort at Colonoscopy

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