NCT03128645

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

April 17, 2017

Last Update Submit

July 21, 2024

Conditions

ColonoscopyComplete ColonoscopyCecum Intubation Timeİleum Intubation Time

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Group 1

Standard method group

Device: Abdominal Corset

Group 2

Abdominal corset group

Device: Abdominal Corset

Interventions

Abdominal CorsetDEVICE

The patient's colonoscopy procedure in group 2 after randomization will be performed with the abdominal corset.

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Kosuyolu Yuksek Ihtisas Education and Research

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (1)

  • Gundes E, Ofkeli O, Uzun O, Senger AS, Polat E, Duman M. Effect of Abdominal Corset on Completion of Colonoscopy and Cecal and Ileocecal Intubation Time in Patients with Central Obesity: A Prospective Randomized Controlled Trial. Ann Ital Chir. 2024;95(4):603-608. doi: 10.62713/aic.3348.

    PMID: 39186356DERIVED

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterological Surgery

Study Record Dates

First Submitted

April 17, 2017

First Posted

April 25, 2017

Study Start

April 1, 2017

Primary Completion

September 1, 2017

Study Completion

December 15, 2017

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)