The Optimal Sequence in Same-day Bidirectional Endoscopy Under Deep Anesthesia.

July 17, 2021 updated by: duowu zou, Ruijin Hospital

The Optimal Sequence in Same-day Bidirectional Endoscopy Under Deep Anesthesia Induced by Propofol Combined With Fentanyl: A Prospective Randomized Controlled ,Two Centers Trial

The purpose of this study is to explore the optimal sequence of same-day bidirectional endoscopy under deep anesthesia induced by propofol combined with fentanyl.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Same-day bidirectional endoscopy are commonly performed to evaluate iron deficiency anemia, positive fecal occult blood, abdominal pain and cancer screening. In order to reducing intraoperative pain, providing better operating conditions and improving the endoscopic examination quality, endoscopy with anesthesia assistance has gradually become the choice of more patients. However, the optimal sequence of procedures for same-day bidirectional endoscopy has not been established. This is a two-center, single-blind, randomized, controlled trial. Patients undergoing same-day bidirectional endoscopy under deep sedation will be randomly assigned to either the colonoscopy-first group (colonoscopy followed by EGD, n = 272) or the EGD(esophagogastroduodenoscopy)-first group (EGD followed by colonoscopy, n = 272).The detection rate of adenoma（ADR）, the ADR of right-side colon , Boston score of right-side colon, total dose of anesthetics, operation time, recovery time, adverse events and patient satisfaction will be evaluated.

Study Type

Interventional

Enrollment (Anticipated)

544

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient with a clinical indication for receiving same day bi-directional endoscopies.

Exclusion Criteria:

  • Contraindications of colonoscopy: acute peritonitis; intestinal perforation or suspected intestinal perforation; acute anorectal infection or painful lesions; menstruation; pregnancy; cardiopulmonary insufficiency; prior abdominal and pelvic surgery.
  • Contraindications for EGD: severe heart disease, severe heart failure; severe lung disease: asthma : severe hypertension; acute perforation of esophagus, stomach and duodenum; acute severe pharynx and larynx disease gastroscopy can not be inserted; acute stage of corrosive esophageal injury; prior upper digestive tract operation.
  • Contraindications for oral intestinal laxative: severe gastrointestinal obstruction or stricture; toxic megacolon; severe acute intestinal infection; dysphagia; disturbance of consciousness; allergy to drug ingredients.
  • Allergic to emulsions or opioids.
  • ASA score ≥ III

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A
EGD performed before the Colonoscopy
Procedure: EGD first
In this group, patients receiving an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients receive deep sedation with propofol and fentanyl.
EXPERIMENTAL: Group B
Colonoscopy performed before the EGD
Procedure: Colonoscopy first
In this group, patients receiving a colonoscopy followed by EGD during a same-day bidirectional endoscopy. Patients receive deep sedation with propofol and fentanyl.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma Detection Rate
Time Frame: 1 year
Adenoma detection rate is the proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected. In this study, ADR during the colonoscopy will recorded.
1 year
Adenoma Detection Rate of the right-sided colon
Time Frame: 1 year
The ADR of right-sided colon will be recorded.Right -sided colon is refered to cecum, ascending colon and ileocecal junction.
1 year
The boston bowel preparation scale of the right-sided colon
Time Frame: 1 year
During colonoscopy, the boston bowel preparation scale of the right-sided colon will be recorded and compared between the two study groups.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation use
Time Frame: 1 year
During bidirectional endoscopy, the total doses of propofol and fentanyl will be recorded.
1 year
Overall Duration of BDE Examinations
Time Frame: 1 year
The overall duration of both EGD and colonoscopy examinations will be recorded.
1 year
Recovery time
Time Frame: 1 year
Time between the end of the procedure and patient waken-up will be recorded.
1 year
Adverse events
Time Frame: 1 year
Intraprocedure adverse events will be documented (oxygen saturation <90% for >30 s, systolic blood pressure drop for 30 %, and heart rate <50 or >120 beats/min lasting >30 s).
1 year
Overall patient satisfaction
Time Frame: 1 year
Patient satisfaction will be assessed after the procedures using 10-cm visual analog scale.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Second Affiliated Hospital of Soochow University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 30, 2021

Primary Completion (ANTICIPATED)

June 30, 2022

Study Completion (ANTICIPATED)

July 30, 2022

Study Registration Dates

First Submitted

July 17, 2021

First Submitted That Met QC Criteria

July 17, 2021

First Posted (ACTUAL)

July 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 17, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RuijinH2021131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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