Pre-procedural Risk Score-Based Endoscopist Assignment for Pain Reduction in Unsedated Colonoscopy

N/ANot Yet RecruitingNCT07713953

Ningbo No. 1 Hospital106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

106

Conditions

Colonoscopy Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of Participants with Moderate-to-Severe Pain During Colonoscopy

Pain intensity is assessed using a VRS-4 ( none, mild, moderate, severe) immediately after the colonoscopy by a research assistant who is blinded to group allocation. Moderate or severe pain is defined as the primary outcome event.

Time frame: Immediately after the colonoscopy procedure

Secondary Outcomes

Adenoma Detection Rate (ADR)

Proportion of participants with at least one histologically confirmed adenoma detected during colonoscopy. All resected polyps are sent for pathological examination.

Time frame: At the time of colonoscopy (pathology results available within 1 week after procedure)

Willingness to Undergo Repeat Unsedated Colonoscopy

Proportion of participants who respond "yes" when asked whether they would be willing to undergo a repeat unsedated colonoscopy in the future.

Time frame: Immediately after the colonoscopy procedure

Patient Satisfaction

Patient satisfaction is assessed by a research assistant using a standardized questionnaire, graded as satisfied, fair, or dissatisfied.

Time frame: Immediately after the colonoscopy procedure

Cecal Intubation Time

Time from endoscope insertion to successful cecal intubation, measured in minutes.

Time frame: During the colonoscopy procedure

Withdrawal Time

Time taken for endoscope withdrawal from the cecum to the rectum, measured in minutes.

Time frame: During the colonoscopy procedure

Abdominal Compression Use Rate

Proportion of participants requiring abdominal compression during the colonoscopy procedure.

Time frame: During the colonoscopy procedure

Position Change Use Rate

Proportion of participants requiring position change during the colonoscopy procedure.

Time frame: During the colonoscopy procedure

Pre-procedural Risk Score-Based Endoscopist Assignment for Pain Reduction in Unsedated Colonoscopy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts