The Effect of the Abdominal Corset on Colonoscopy

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

In patients with central obesity, the effect of the abdominal corset on colonoscopy completeness, cecum and ileum intubation time will be investigated.

Study Overview

• Status: Unknown
• Conditions: Colonoscopy; Complete Colonoscopy; Cecum Intubation Time; İleum Intubation Time
• Intervention / Treatment: Device: Abdominal Corset

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Mustafa MD Duman; Phone Number: 1176 0216 500 1500; Email: drmustafaduman@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Recruiting
    • Kartal Kosuyolu Yuksek Ihtisas Education and Research
    • Contact: Hilal Yıldırım; Phone Number: 1176 0216 500 1500; Email: etikkurul@kosuyolu.gov.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients who were remotely applying to our clinic and planned for colonoscopy according to ASGE colonoscopy indications.

Description

Inclusion Criteria:

• Above 18 years, Meeting the central obesity criteria Cases where colonoscopy is performed under elective conditions

Exclusion Criteria:

• In case of emergency, The process is terminated due to bad bowel preparation, Inflammatory bowel disease, Serious arrhythmia, Chronic obstructive pulmonary disease Coronary artery disease The previous abdominal surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Standard method group	Device: Abdominal Corset; The patient's colonoscopy procedure in group 2 after randomization will be performed with the abdominal corset.
Group 2; Abdominal corset group	Device: Abdominal Corset; The patient's colonoscopy procedure in group 2 after randomization will be performed with the abdominal corset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Obesity	BMI ≥ 30 (kg / m2), waist circumference> 102 cm in men and waist circumference> 88 cm in women	01/04/2017- 01/06/2017
Cecum intubation time	Insertion time of the colonoscope from anus to the cecum (second)	01/04/2017- 01/06/2017
İleum intubation time	Insertion time of the colonoscope from cecum to the ileum (second)	01/04/2017- 01/06/2017

Collaborators and Investigators

• Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 15, 2017

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2017/3/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No