IRCT | Comparison of the effect of mechanical intestinal preparation with 6 and 4 packaged Polyethylene glycol with telephon based re-education before colonoscopy on adequacy of intestinal preparation, safety and acceptance of patients undergoing colonoscopy.

Protocol summary

Study aim: Comparison mechanical intestinal preparation with 6 and 4 packaged Polyethyleneglycol with telephon based re-education on adequacy of intestinal preparation, safety and acceptance of patients undergoing colonoscopy
Design: The intervention consists of 3 different groups as follows: the first group 4 packed polyethylene glycol , the second group 6 packed polyethylene glycol and the third group 4 packed polyethylene glycol with telephone base re-education. The groups were selected randomly using spss statistical software.
Settings and conduct: The site of sampling is the endoscopy department of Ghaem Hospital
Participants/Inclusion and exclusion criteria: 1.To be satisfied to participate in the study. 2.Aged 18 to 64 years old. 3.At the present time, Not to be treated for liver and kidney disease. 4.There are no symptoms of intestinal obstruction (prolonged constipation, abdominal distension and sometimes sensitivity to touch, abdominal pain, nausea and vomiting, certain radiographic findings). 5.Has not History of surgery to remove all or part of the colon 6.Not be Pregnant 7.Not have hearing problem. Exclusion criteria 1.The Intestinal preparation protocol Completely dose not implementation. 2.Do not want to continue to cooperate
Intervention groups: The first group was 4 packed polyethylene glycols, the second group 6 packed polyethylene glycol and the third group 4 packed polyethylene glycol with telephone based re-education on before colonoscopy day.
Main outcome variables: The main consequences include adequacy of intestinal preparation, safety and patient acceptance under colonoscopy

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20171120037552N2

Registration date: 2018-11-13, 1397/08/22

Registration timing: retrospective

Last update: 2018-11-13, 1397/08/22

Update count: 0
Registration date: 2018-11-13, 1397/08/22

Registrant information: Name

سیده نسرین ماشاالله

Name of organization / entity

دانشکده پرستاری و مامایی دانشگاه علوم پزشکی مشهد

Country

Iran (Islamic Republic of)

Phone

+98 84 1300 7051

Email address

mashallahn931@mums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-03-21, 1397/01/01
Expected recruitment end date: 2018-08-21, 1397/05/30
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the effect of mechanical intestinal preparation with 6 and 4 packaged Polyethylene glycol with telephon based re-education before colonoscopy on adequacy of intestinal preparation, safety and acceptance of patients undergoing colonoscopy.

Public title: Comparison of the effect of mechanical intestinal preparation with Polyethylene glycol
Purpose: Diagnostic
Inclusion/Exclusion criteria: Inclusion criteria:

To be satisfied to participate in the study . Aged 18 to 64 years old. At the present time, Not to be treated for liver and kidney disease. There are no symptoms of intestinal obstruction (prolonged constipation, abdominal distension and sometimes sensitivity to touch, abdominal pain, nausea and vomiting, certain radiographic findings). Has not History of surgery to remove all or part of the colon. Not be Pregnant. Not have hearing problem.

Exclusion criteria:

The Intestinal preparation protocol Completely dose not implementate. Do not want to continue to cooperation.
Age: From 18 years old to 64 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Care provider
Outcome assessor

Sample size

Target sample size: 100

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization tool using statistical software

Blinding (investigator's opinion)

Double blinded

Blinding description

1-Patients in the study are not known About the type of preparation regimen. 2-Routine Complications Preparation is measured through a Special research tool By researcher help that does not know of the preparation regimen. 3-The endoscopic specialist does not know the type of bowel preparation.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee Mashhad University of medical sciences

Street address

Gaem hospital

City

Mashhad

Province

Razavi Khorasan

Postal code

91766-99199
Approval date: 2018-02-17, 1396/11/28
Ethics committee reference number: IR.MUMS.REC.1396.380

Health conditions studied

1

Description of health condition studied: Patients under colonoscopy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Adequacy of intestinal preparation, safety and patient acceptance under colonoscopy
Timepoint: Day of recurrences for colonoscopy and the day of colonoscopy
Method of measurement: The adequacy of intestinal preparation through the Boston instrument and the patient's acceptance through a checklist questionnaire and the safety of the patient are measured by checking blood electrolytes.

Secondary outcomes

empty

Intervention groups

1

Description: Control group: Four polyethylene glycol packages. Interventions include: On the first day, patients will eat soft diet and much fluid at least 24 to 30 glasses . The second day, patients will eat' Smooth fluid and much fluid at least 24 to 30 glasses a day. Patients on the day of referral receive 4 packets of polyethylene glycol, 6 bisacodyl tablet and one bisacodyl suppository per day for colonoscopy. Patients take 2 packs of this powder plus 4 tablet of bisacodyl on the day before colonoscopy, and 2 packs of polyethylene glycol, 2 tablet of biacodyl and one bisacodyl suppository are taken on the morning of the colonoscopy. Also on the referral and colonoscopy day Blood tests are taken from patients. These tests include Mg, P, Na, k, Ca, BUN.cr.
Category: Diagnosis

2

Description: Intervention group 1: Six packet of polyethylene glycol. Interventions include: On the first day, patients will eat soft diet and much fluid at least 24 to 30 glasses . The second day, patients will eat' Smooth fluid and much fluid at least 24 to 30 glasses a day. Patients on the day of referral receive 6 packets of polyethylene glycol, 10 bisacodyl tablet and one bisacodyl suppository per day for colonoscopy. Patients take 4 packs of this powder plus 8 tablet of bisacodyl on the day before colonoscopy, and 2 packs of polyethylene glycol, 2 tablet of biacodyl and one bisacodyl suppository are taken on the morning of the colonoscopy. Also on the referral and colonoscopy day Blood tests are taken from patients. These tests include Mg, P, Na, k, Ca, BUN.cr.
Category: Diagnosis

3

Description: Intervention group 2: Four polyethylene glycol packets by telephone base re-education. Interventions include: On the first day, patients will eat soft diet and much fluid at least 24 to 30 glasses . The second day, patients will eat' Smooth fluid and much fluid at least 24 to 30 glasses a day. Patients on the day of referral receive 4 packets of polyethylene glycol, 6 bisacodyl tablet and one bisacodyl suppository per day for colonoscopy. Patients take 2 packs of this powder plus 4 tablet of bisacodyl on the day before colonoscopy, and 2 packs of polyethylene glycol, 2 tablet of biacodyl and one bisacodyl suppository are taken on the morning of the colonoscopy.In addition, the nurse on the day before the colonoscopy (second day), followed by a 5 to 10 minute phone call follow up by the patients in the third group and responded if there was a question. Also on the referral and colonoscopy day Blood tests are taken from patients. These tests include Mg, P, Na, k, Ca, BUN.cr.
Category: Diagnosis

Recruitment centers

1

Recruitment center: Name of recruitment center

Endoscopy Center of Ghaem Hospital

Full name of responsible person

Dr mostafa dastani

Street address

Shariati Square Beginning of Boulevard Ahmad Abad

City

Mashhad

Province

Razavi Khorasan

Postal code

91766-99199

Phone

+98 51 3840 1532

Email

Quaem.Medical.Center@mums.ac.ir

1

Sponsor: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Dr Mohsen Tafaghodi

Street address

Mashhad,beside Hoveize cinema.

City

Mashhad

Province

Razavi Khorasan

Postal code

99191-91778

Phone

+98 51 3841 1548

Fax

+98 51 3871 3638

Email

Vcresearch@mums.ac.ir

Web page address

http://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Mashhad University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Seyed Reza Mazlom

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Nursery

Street address

Faculty of Nursing and Midwifery, Avicenna St., Avicenna Street, Mashhad, Iran.

City

Mashhad

Province

Razavi Khorasan

Postal code

9137913199

Phone

+98 51 3859 1511

Fax

+98 51 3859 1511

Email

Mazlomr@mums.ac.ir

Web page address

http://nurse.mums.ac.ir/

Person responsible for scientific inquiries

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Seyed Reza Mazlom

Position

Professor

Latest degree

Ph.D.

Other areas of specialty/work

Nursery

Street address

Faculty of Nursing and Midwifery, Avicenna St., Avicenna Street, Mashhad, Iran.

City

Mashhad

Province

Razavi Khorasan

Postal code

9137913199

Phone

+98 51 3859 1511

Fax

+98 51 3859 1511

Email

mazlomr@mums.ac.ir

Web page address

http://nurse.mums.ac.ir/

Person responsible for updating data

Contact: Name of organization / entity

Mashhad University of Medical Sciences

Full name of responsible person

Seyede Nasrin Mashallah

Position

Master student

Latest degree

Bachelor

Other areas of specialty/work

Nursery

Street address

Mashhad, Toos BLVD, Toos 65.12, No 36

City

Mashhad

Province

Razavi Khorasan

Postal code

91918-87875

Phone

+98 51 3658 3276

Fax

+98 51 3658 3276

Email

mashallahn931@mums.ac.ir

Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: The file contains patient information in the colonoscopy section.
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: Part of the information that relates to the outcomes Unidentifiable will be shared.
When the data will become available and for how long: Start the access period 6 months after the results are published
To whom data/document is available: People working in scientific and academic and industry
Under which criteria data/document could be used: Doing an analysis on study data is not allowed
From where data/document is obtainable: seyede nasrin mashallah
What processes are involved for a request to access data/document: If available and authorized to provide requested items as soon as possible
Comments

Comparison of the effect of mechanical intestinal preparation with 6 and 4 packaged Polyethylene glycol with telephon based re-education before colonoscopy on adequacy of intestinal preparation, safety and acceptance of patients undergoing colonoscopy.