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NCT07713953

Overview

NCT ID: NCT07713953
Lead Sponsor: Ningbo No. 1 HospitalOTHER
Official Title: Effect of a Pre-procedural Risk Score-Based Endoscopist Assignment Strategy on Intraprocedural Pain in Unsedated Colonoscopy: A Multicenter Randomized Controlled Trial
Brief Summary: This multicenter randomized controlled trial evaluates whether a pre-procedural risk score-based endoscopist assignment strategy reduces intraprocedural pain in high-risk patients undergoing unsedated colonoscopy. High-risk patients (risk score >5) are randomized 1:1 to either the intervention group (examination performed by expert endoscopists with ≥5,000 colonoscopy experiences) or the control group (examination performed by endoscopists assigned per routine hospital scheduling). The primary outcome is the proportion of patients reporting moderate-to-severe pain during colonoscopy, assessed by a blinded research assistant using a 4-point VRS. A total of 106 high-risk patients will be enrolled from two centers in China.
Conditions: Colonoscopy Pain

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Jul 20, 2026Estimated
Primary Completion Date: Jul 21, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Age 18-75 years.

Outpatient or inpatient undergoing colonoscopy for medical screening, polyp surveillance, or polypectomy.

Pre-procedural risk score >5 (based on the following scoring system: BMI <19 [5 points], female sex [1 point], history of abdominal or pelvic surgery [2 points], constipation [3 points]).

Exclusion Criteria:

Patients who have received sedation or analgesia prior to colonoscopy.

Patients unwilling to cooperate or unable to provide informed consent.

Incomplete intestinal obstruction.

Inflammatory bowel disease, multiple polyposis syndromes, or severe chronic cardiac or pulmonary disease.

Patients receiving anticoagulant therapy.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 106Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Lei XuContact
xulei22@163.com+86 13486659126

Similar Studies

Participant Group/Arms

Risk Score-based Endoscopist AssignmentExperimental

High-risk patients (pre-procedural risk score \>5) undergoing unsedated colonoscopy are assigned to expert endoscopists who have completed ≥5,000 colonoscopy procedures.

Other: Risk Score-Based Endoscopist Assignment

Routine Hospital Scheduling AssignmentNo Intervention

High-risk patients (pre-procedural risk score \>5) undergoing unsedated colonoscopy are assigned to endoscopists according to routine hospital scheduling, which may include both expert and non-expert endoscopists.