Supine Position for Colonoscopy Insertion

Not Applicable

Completed

• Conditions: Colonoscopy Insertion; Patient Position
• Interventions: Procedure: supine position

• Registration Number: NCT03289442
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-09-17
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-21
• Primary Completion: 2018-01-01
• Study Completion: 2018-07-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 347

Inclusion Criteria

1. aged between 18-75 years
2. underwent screening, surveillance, and diagnostic colonoscopy

Exclusion Criteria

1. <18 or >75 years old
2. major psychiatric disorders, colonic resection, pregnancy, presence of any contraindications for colonoscopy (eg, severe heart failure, renal insufficiency)
3. Patients with severe cardiopulmonary and renal disease
4. Patients who are unwilling or unable to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supine position group	supine position	-

Primary Outcome Measures

Name	Time	Method
cecal intubation time	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 Outcome Measures

Name	Time	Method
patients' acceptance to unsedated or sedated colonoscopy in the future screening or examination	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
patients' pain score	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
descending colon intubation time	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.

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China