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Completed

NCT Number: NCT03289442

Supine Position for Colonoscopy Insertion

The purpose of this study is to determine whether the supine position is better than the left lateral horizontal body position to decrease cecal intubation time, patients' pain and the difficulty of colonoscopy insertion.

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Key information

Conditions

Colonoscopy Insertion Patient Position

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

About this study

Left lateral position is conventionally performed to initiate colonoscopy, yet no evidence has demonstrated its efficacy and advantages. Left lateral position for insertion, which results in air rising away from the left colon and producing acute bends in the sigmoid,might increase the risk of colonoscopy loop formation.When there is difficulty advancing the colonoscope, supine position can be employed to ensure cecal intubation. Therefore, we perform a randomized controlled trial to compares supine position with left lateral position for the safety and efficacy of colonoscopy insertion.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged between 18-75 years
  • underwent screening, surveillance, and diagnostic colonoscopy

Exclusion criteria

  • <18 or >75 years old
  • major psychiatric disorders, colonic resection, pregnancy, presence of any contraindications for colonoscopy (eg, severe heart failure, renal insufficiency)
  • Patients with severe cardiopulmonary and renal disease
  • Patients who are unwilling or unable to consent

Treatment and study plan

Supine position

Procedure

patients were positioned on their supine position to receive colonoscopy insertion

Primary outcomes

  1. cecal intubation time

    Time frame: 2 hour

    Cecal intubation time is the insertion time taken from first visualization of rectal mucosa to cecum and cecal intubation was confirmed by identifying the characteristic anatomical landmarks of the triradiate fold, appendiceal orifice, and ileocecal valve.

Secondary outcomes

  1. descending colon intubation time

    Time frame: 1 hour

    Descending colon intubation time is the insertion time taken from first visualization of rectal mucosa to descending colon and descending colon was identified by the presence of straight colonic lumen and affirmed by an independent observer simultaneously.

  2. patients' pain score

    Time frame: 3 hour

    patients' discomfort will be assessed by a 10-cm visual analog scale, in which a score of 0 denoted no pain and a score of 10 denoted unbearable pain

  3. patients' acceptance to unsedated or sedated colonoscopy in the future screening or examination

    Time frame: 3 hour

    when colonoscopy insertion is completed, patients will be asked whether they would accept similar unsedated or sedated colonoscopy in the future screening or examination

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • No.85 Hospital, Changning, Shanghai, China

Registry information

Official study title

Impact of Supine Position on Colonoscopy Insertion: a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2017
Registry last updated
Nov 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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