Minimal Water Exchange Versus Left Water Exchange in Unsedated Colonoscopy

NCT04952142 | Completed

• 1 other identifier: 2021CR320
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Minimal water exchange colonoscopy is theoretically more convenient and faster than water exchange colonoscopy. But few studies compared the differences between the two methods. Therefore, we attempted to evaluate the effect of minimal water exchange colonoscopy prospectively.

Conditions

Water Exchange Colonoscopy

Keywords

water-aided colonoscopy

Outcome Measures

Primary Outcomes (1)

• VRS-4 pain scores

  a 4-point verbal rating scale (VRS-4) with self-explanatory categories (no, slight, moderate, or severe pain).

  30 minutes.

Secondary Outcomes (1)

• Adenoma detection rate.

  40 minutes.

Study Arms (2)

minimal water exchange

EXPERIMENTAL

We suctioned the lumen and infused water by constant pressure on the air-water valve button of the endoscope at the rectum to open the lumen.

Other: minimal water exchange

traditional water exchange colonoscopy

NO INTERVENTION

The water exchange colonoscopy reached the cecum through continuous infusion and suction of water in the whole colon via an additional flushing pump.

Interventions

minimal water exchange OTHER

Use a new technique, minimal water exchange colonoscopy, which adds the infusion of modest amounts of water by constant pressure on the air-water valve button of the endoscope to achieve intubation.

minimal water exchange

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 75 years for unsedated colonoscopy for colorectal cancer screening, polyp surveillance, or polyp resection were enrolled.

You may not qualify if:

• Patients who underwent sedation or analgesia before colonoscopy, and were reluctant to cooperate or provide informed consent. Those who were suffering from too serious diseases to tolerate the examination. The intestinal segment was incomplete or the colonoscopy did not reach the cecum.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

Ningbo first hospital

Ningbo, Zhejiang, 315010, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 7, 2021
• Study Start: April 22, 2021
• Primary Completion: September 10, 2021
• Study Completion: September 30, 2021
• Last Updated: November 10, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)