NCT07517848

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

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

February 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

December 6, 2025

Last Update Submit

April 4, 2026

Conditions

Keywords

colonoscopyendoscopycolorectal cancercolon polyps

Outcome Measures

Primary Outcomes (1)

  • Cecal intubation time

    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 Outcomes (3)

  • Pain score during colonoscopy

    Immediately after colonoscopy

  • Endoscopist-rated procedure difficulty

    Immediately after colonoscopy

  • Changes in vital signs during colonoscopy

    During the colonoscopy procedure

Study Arms (2)

Supine position (SP)

OTHER

The first group consisted of patients assigned to the supine position (SP) as the initial position for colonoscopy

Procedure: Colonoscopy after bowel cleansingDevice: Colonoscopy after bowel cleansing

Lateral Left Horizontal Position (LLP)

OTHER

The second group consisted of patients assigned to the left lateral horizontal position (LLP) as the initial position for colonoscopy

Procedure: Colonoscopy after bowel cleansingDevice: Colonoscopy after bowel cleansing

Interventions

Colonoscopy after bowel cleansing

Lateral Left Horizontal Position (LLP)Supine position (SP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and male patients over 18 years of age who have been medically indicated for colonoscopy and have signed the voluntary consent form.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar University

Manisa, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsColonic Polyps

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesIntestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2025

First Posted

April 8, 2026

Study Start

February 1, 2021

Primary Completion

October 1, 2023

Study Completion

August 15, 2024

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Anonymized study results

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning 1 month after publication with no end date

Locations