- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07517848
Comparison of the Left-Lateral Horizontal and Supine Positions for Colonoscopy Intervention: A Randomized Controlled Study
Objective: One of the most common technical difficulties during colonoscopy is passing through the fold of the sigmoid colon. Colonoscopy is commonly performed by endoscopists with the patient in the left lateral position. When the procedure is initiated in the left lateral position, insufflation of the bowel may result in a sharper angulation of the sigmoid colon, making advancement of the colonoscope more difficult. This study aimed to compare colonoscopic procedures initiated in the left lateral position and the supine position.
Materials and Methods: Colonoscopy was performed on 198 participants who had an indication for colonoscopy at the General Surgery clinic and met the study inclusion criteria. All procedures were conducted by the same endoscopist (Dr. Semra Tutcu Şahin) in the Endoscopy Unit during working hours. Participants were randomly assigned to two groups:
Group 1: Participants whose starting position for colonoscopy was supine (n=97) Group 2: Participants whose starting position for colonoscopy was left lateral (n=101)
During colonoscopy, participants' demographic data, vital signs, and the time required for the endoscopist to reach the cecum were recorded. At the end of the procedure, participants completed a pain scale, and the endoscopist completed an observation scale. The data were entered into the SPSS program and analyzed.
Study Overview
Status
Intervention / Treatment
Detailed Description
Objective: One of the most common technical difficulties during colonoscopy is passing through the fold of the sigmoid colon. Colonoscopy is commonly performed by endoscopists with the patient in the left lateral position. When the procedure is initiated in the left lateral position, insufflation of the bowel may result in a sharper angulation of the sigmoid colon, making advancement of the colonoscope more difficult. This study aimed to compare colonoscopic procedures initiated in the left lateral position and the supine position.
Materials and Methods: Colonoscopy was performed on 198 participants who had an indication for colonoscopy at the General Surgery clinic and met the study inclusion criteria. All procedures were conducted by the same endoscopist (Dr. Semra Tutcu Şahin) in the Endoscopy Unit during working hours. Participants were randomly assigned to two groups:
Group 1: Participants whose starting position for colonoscopy was supine (n=97) Group 2: Participants whose starting position for colonoscopy was left lateral (n=101)
During colonoscopy, participants' demographic data, vital signs, and the time required for the endoscopist to reach the cecum were recorded. At the end of the procedure, participants completed a pain scale, and the endoscopist completed an observation scale. The data were entered into the SPSS program and analyzed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Manisa, Turkey (Türkiye)
- Manisa Celal Bayar University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female and male patients over 18 years of age who have been medically indicated for colonoscopy and have signed the voluntary consent form.
Exclusion Criteria:
- Patients under 18 years of age
- Patients who do not give informed consent
- Pregnant women
- Patients requesting sedation
- Patients with an indication for emergency colonoscopy
- Patients with a history of colon resection
- Major psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Supine position (SP)
The first group consisted of patients assigned to the supine position (SP) as the initial position for colonoscopy
|
Colonoscopy after bowel cleansing
COLONOSCOPY WITH LEFT LATERAL AND SUPINE POSITION
|
|
Other: Lateral Left Horizontal Position (LLP)
The second group consisted of patients assigned to the left lateral horizontal position (LLP) as the initial position for colonoscopy
|
Colonoscopy after bowel cleansing
COLONOSCOPY WITH LEFT LATERAL AND SUPINE POSITION
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cecal intubation time
Time Frame: During the colonoscopy procedure
|
Time (in seconds) from insertion of the colonoscope at the anal verge to successful cecal intubation, defined by visualization of the appendiceal orifice and ileocecal valve, recorded by the endoscopist.
|
During the colonoscopy procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score during colonoscopy
Time Frame: Immediately after colonoscopy
|
Pain intensity assessed immediately after the procedure using a 10-point Visual Analog Scale (VASP), where 0 indicates no pain and 10 indicates worst imaginable pain.
|
Immediately after colonoscopy
|
|
Endoscopist-rated procedure difficulty
Time Frame: Immediately after colonoscopy
|
Procedure difficulty assessed immediately after colonoscopy using a 4-point Likert scale (1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult), as rated by the endoscopist.
|
Immediately after colonoscopy
|
|
Changes in vital signs during colonoscopy
Time Frame: During the colonoscopy procedure
|
Heart rate (beats per minute) measured at baseline and at 5-minute intervals during the procedure.
The maximum change from baseline will be recorded.
|
During the colonoscopy procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- McKechnie T, Heimann L, Kazi T, Jessani G, Lee Y, Sne N, et al. Starting position during colonoscopy: a systematic review and meta-analysis of randomized controlled trials. Tech Coloproctol [Internet]. 2024;28.
- Watanabe J. Comparison of left versus right lateral starting position on colonoscopy: A systematic review and meta-analysis of randomized controlled trials. Ann Gastroenterol. 2021;34:699-704.
- Watanabe J, Park D, Kakehi E, Inoue K, Ishikawa S, Kataoka Y. Efficacy and safety of the starting position during colonoscopy: a systematic review and meta-analysis. Endosc Int Open. 2020;08:848-60.
- 1. Li N, Lu B, Luo C, Cai J, Lu M, Zhang Y, et al. Incidence, mortality, survival, risk factor and screening of colorectal cancer: A comparison among China, Europe, and northern America. Cancer Lett. 2021;522:255-68.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Pathological Conditions, Anatomical
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Polyps
- Intestinal Polyps
- Pathological Conditions, Signs and Symptoms
- Colorectal Neoplasms
- Colonic Neoplasms
- Colonic Polyps
Other Study ID Numbers
- CelalBayarU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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