NCT04973878

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
544

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

July 30, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

July 17, 2021

Last Update Submit

July 17, 2021

Conditions

Bidirectional EndoscopyDeep Sedation

Keywords

Bidirectional EndoscopyDeep Sedation

Outcome Measures

Primary Outcomes (3)

  • Adenoma Detection Rate

    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

    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

    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 Outcomes (5)

  • Sedation use

    1 year

  • Overall Duration of BDE Examinations

    1 year

  • Recovery time

    1 year

  • Adverse events

    1 year

  • Overall patient satisfaction

    1 year

Study Arms (2)

Group A

EXPERIMENTAL

EGD performed before the Colonoscopy

Procedure: EGD first

Group B

EXPERIMENTAL

Colonoscopy performed before the EGD

Procedure: Colonoscopy first

Interventions

EGD firstPROCEDURE

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.

Group A
Colonoscopy firstPROCEDURE

In this group, patients receiving a colonoscopy followed by EGD during a same-day bidirectional endoscopy. Patients receive deep sedation with propofol and fentanyl.

Group B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Urquhart J, Eisen G, Faigel DO, Mattek N, Holub J, Lieberman DA. A closer look at same-day bidirectional endoscopy. Gastrointest Endosc. 2009 Feb;69(2):271-7. doi: 10.1016/j.gie.2008.04.063. Epub 2008 Aug 23.

    PMID: 18725159BACKGROUND

  • Cairns SR, Scholefield JH, Steele RJ, Dunlop MG, Thomas HJ, Evans GD, Eaden JA, Rutter MD, Atkin WP, Saunders BP, Lucassen A, Jenkins P, Fairclough PD, Woodhouse CR; British Society of Gastroenterology; Association of Coloproctology for Great Britain and Ireland. Guidelines for colorectal cancer screening and surveillance in moderate and high risk groups (update from 2002). Gut. 2010 May;59(5):666-89. doi: 10.1136/gut.2009.179804.

    PMID: 20427401BACKGROUND

  • Lucendo AJ, Arias A, Gonzalez-Castillo S, Angueira T, Guagnozzi D, Fernandez-Fuente M, Serrano-Valverde M, Sanchez-Cazalilla M, Chumillas O, Fernandez-Ordonez M, Tenias JM. Same-day bidirectional endoscopy with nonanesthesiologist administration of propofol: safety and cost-effectiveness compared with separated exams. Eur J Gastroenterol Hepatol. 2014 Mar;26(3):301-8. doi: 10.1097/MEG.0000000000000026.

    PMID: 24365718BACKGROUND

  • Yang C, Sriranjan V, Abou-Setta AM, Poluha W, Walker JR, Singh H. Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review. Am J Gastroenterol. 2018 Dec;113(12):1810-1818. doi: 10.1038/s41395-018-0398-8. Epub 2018 Nov 1.

    PMID: 30385831BACKGROUND

  • Lu Y, Hao LX, Chen L, Jin Z, Gong B. Systematic review and meta-analysis of patient-controlled sedation versus intravenous sedation for colonoscopy. Int J Clin Exp Med. 2015 Nov 15;8(11):19793-803. eCollection 2015.

    PMID: 26884890BACKGROUND

  • Igea F, Casellas JA, Gonzalez-Huix F, Gomez-Oliva C, Baudet JS, Cacho G, Simon MA, De la Morena E, Lucendo A, Vida F; Spanish Society of Digestive Endoscopy. Sedation for gastrointestinal endoscopy. Endoscopy. 2014 Aug;46(8):720-31. doi: 10.1055/s-0034-1377561. Epub 2014 Jul 25. No abstract available.

    PMID: 25061964BACKGROUND

  • Bugajski M, Wieszczy P, Hoff G, Rupinski M, Regula J, Kaminski MF. Modifiable factors associated with patient-reported pain during and after screening colonoscopy. Gut. 2018 Nov;67(11):1958-1964. doi: 10.1136/gutjnl-2017-313905. Epub 2017 Sep 28.

    PMID: 28970289BACKGROUND

  • Grocott HP. Propofol sedation improves efficiency and optimizes patient satisfaction during colonoscopy. CMAJ. 2018 Jun 18;190(24):E751. doi: 10.1503/cmaj.69279. No abstract available.

    PMID: 29914915BACKGROUND

  • Wadhwa V, Issa D, Garg S, Lopez R, Sanaka MR, Vargo JJ. Similar Risk of Cardiopulmonary Adverse Events Between Propofol and Traditional Anesthesia for Gastrointestinal Endoscopy: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2017 Feb;15(2):194-206. doi: 10.1016/j.cgh.2016.07.013. Epub 2016 Jul 21.

    PMID: 27451091BACKGROUND

  • Cao Y, Yang J, Li J, Ao X, Zhang KY, Shen XC, Chen DF, Lan CH. Comparison of procedural sequences in same-day painless bidirectional endoscopy: Single-center, prospective, randomized study. Dig Endosc. 2017 May;29(3):330-337. doi: 10.1111/den.12847. Epub 2017 Mar 30.

    PMID: 28211094BACKGROUND

  • Hsieh YH, Lin HJ, Tseng KC. Which should go first during same-day bidirectional endosocopy with propofol sedation? J Gastroenterol Hepatol. 2011 Oct;26(10):1559-64. doi: 10.1111/j.1440-1746.2011.06786.x.

    PMID: 21615790BACKGROUND

  • Hammami MB, Reddy KM, Pandit P, Chahla EJ, Koro N, Schuelke MJ, Hachem C. Sequence of same-day upper and lower gastrointestinal endoscopy does not affect total procedure' time or medication use: A randomized trial. JGH Open. 2019 Aug 6;3(6):488-493. doi: 10.1002/jgh3.12203. eCollection 2019 Dec.

    PMID: 31832549BACKGROUND

  • Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Gastrointest Endosc. 2015 Jan;81(1):31-53. doi: 10.1016/j.gie.2014.07.058. Epub 2014 Dec 2. No abstract available.

    PMID: 25480100BACKGROUND

  • Chokshi RV, Hovis CE, Hollander T, Early DS, Wang JS. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc. 2012 Jun;75(6):1197-203. doi: 10.1016/j.gie.2012.01.005. Epub 2012 Feb 28.

    PMID: 22381531BACKGROUND

Study Officials

  • Duowu Zou, Ph.D,M.D

    Ruijin hospital Shanghai Jiaotong Universtity, school of medicine

    STUDY CHAIR

Central Study Contacts

Duowu Zou, Ph.D,M.D

CONTACT

+86 13901617608zdw_pi@163.com

Chunhua Zhou, Ph.D,M.D

CONTACT

+86 13616275889zhou_chunh@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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-first group (EGD followed by colonoscopy, n = 272).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. and director

Study Record Dates

First Submitted

July 17, 2021

First Posted

July 22, 2021

Study Start

July 30, 2021

Primary Completion

June 30, 2022

Study Completion

July 30, 2022

Last Updated

July 22, 2021

Record last verified: 2021-07