Left Lateral Position Versus Supine Position in Colonoscopy

NCT06664762 | Completed Results DMC

• 1 other identifier: 150/24
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

Brief Summary

Currently, colonoscopy is a minimally invasive method that can be used as a diagnostic and therapeutic method by endoscopists, gastroenterologists and coloproctologists. Due to the importance and big impact this method has, it is necessary to both optimize its efficiency, and improve its quality, which is one of the main objectives of this protocol. By observing which position its faster and which one also results in fewer complications when performing a colonoscopy without reducing its performance and following all the internationally established quality standards regarding colonoscoscopy. The risk of this protocol implies a risk no greater than the minumum the procedure itself has, and does not generate extra cost for all of the patients subjected to this protocol.

Conditions

Colorectal Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Time to Cecal Intubation.

  Time since insertion to cecal intubation despite the position for colonoscopy

  4-10 minutes, which is approximately 240-600 seconds

Secondary Outcomes (1)

• Number of Participants With at Least One Adenoma Detected During Colonoscopy

  During colonoscopy

Study Arms (2)

Left lateral position during colonoscopy

ACTIVE COMPARATOR

Behavioral: Left lateral position intervention

Supine position during colonoscopy

ACTIVE COMPARATOR

Behavioral: Supine position intervention

Interventions

Left lateral position intervention BEHAVIORAL

Patients will be randomized and asigned to start and remain in left lateral position during the colonoscopy

Left lateral position during colonoscopy

Supine position intervention BEHAVIORAL

Patients will be randomized and asigned to start and remain in supine position during the colonoscopy

Supine position during colonoscopy

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with indication for colonoscopy in our coloproctology service
• Both women and men
• Patients within an age range of 18-79 years
• Patients who agree having a colonoscopy and who sign the informed consent to participate in the protocol

You may not qualify if:

• Patients under 18 or over 80 years old
• All patients that won´t like to participate in the protocol or won´t sign the informed consent
• Pregnant women
• Patients with a medical record of colonic resection, ostomy status, severe cardiopulmonary and renal diseases, major psychiatric disorders, therapeutic colonoscopy or any contraindications for colonoscopy
• Non compliance with the colonic preparation regimen
• Active bleeding during the procedure
• Patients with a known diagnosis of colorectal cancer
• Patients with class III obesity
• Elimination criteria:
• Boston score \<6 for colonic preparation
• Patients with a colonic lesion that makes it difficult to pass the colonoscope
• Patients with insufficient sedation that requires the procedure to stop temporarily
• Bowel perforation during colonoscopy
• Inability to reach the cecum despite loop reduction maneuvers
• Indication to suspend the study given by the anesthesiologist

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead
• Hospital Civil Juan I. Menchaca: collaborator
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (3)

Antigüo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Jalisco, 44200, Mexico

Location

Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"

Guadalajara, Jalisco, 44340, Mexico

Location

IMSS Hospital General Regional 220 "José Vicente Villada"

México, Toluca de Lerdo, 50150, Mexico

Location

Related Publications (14)

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  PMID: 11464632 BACKGROUND

• Spaner SJ, Warnock GL. A brief history of endoscopy, laparoscopy, and laparoscopic surgery. J Laparoendosc Adv Surg Tech A. 1997 Dec;7(6):369-73. doi: 10.1089/lap.1997.7.369.

  PMID: 9449087 BACKGROUND

• Antoniou SA, Antoniou GA, Koutras C, Antoniou AI. Endoscopy and laparoscopy: a historical aspect of medical terminology. Surg Endosc. 2012 Dec;26(12):3650-4. doi: 10.1007/s00464-012-2389-y. Epub 2012 Jun 21.

  PMID: 22717798 BACKGROUND

• Irving MH, Catchpole B. ABC of colorectal diseases. Anatomy and physiology of the colon, rectum, and anus. BMJ. 1992 Apr 25;304(6834):1106-8. doi: 10.1136/bmj.304.6834.1106. No abstract available.

  PMID: 1586826 BACKGROUND

• van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.

  PMID: 16454841 BACKGROUND

• Neilson LJ, Bevan R, Panter S, Thomas-Gibson S, Rees CJ. Terminal ileal intubation and biopsy in routine colonoscopy practice. Expert Rev Gastroenterol Hepatol. 2015 May;9(5):567-74. doi: 10.1586/17474124.2015.1001744. Epub 2015 Jan 12.

  PMID: 25582839 BACKGROUND

• Vergis N, McGrath AK, Stoddart CH, Hoare JM. Right Or Left in COLonoscopy (ROLCOL)? A Randomized Controlled Trial of Right- versus Left-Sided Starting Position in Colonoscopy. Am J Gastroenterol. 2015 Nov;110(11):1576-81. doi: 10.1038/ajg.2015.298. Epub 2015 Sep 29.

  PMID: 26416195 BACKGROUND

• Vergis N, Scarborough AJ, Morris JA, Hoare JM. Prone or Left for Colonoscopy? A Randomized Controlled Trial of Prone Versus Left-sided Starting Position for Colonoscopy. J Clin Gastroenterol. 2018 Nov/Dec;52(10):e82-e86. doi: 10.1097/MCG.0000000000000871.

  PMID: 28644314 BACKGROUND

• Zhao S, Yang X, Meng Q, Wang S, Fang J, Qian W, Xia T, Pan P, Wang Z, Gu L, Chang X, Zou D, Li Z, Bai Y. Impact of the supine position versus left horizontal position on colonoscopy insertion: a 2-center, randomized controlled trial. Gastrointest Endosc. 2019 Jun;89(6):1193-1201.e1. doi: 10.1016/j.gie.2019.01.009. Epub 2019 Jan 18.

  PMID: 30660634 BACKGROUND

• 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: 22381531 BACKGROUND

• Cappell MS, Friedel D. The role of sigmoidoscopy and colonoscopy in the diagnosis and management of lower gastrointestinal disorders: technique, indications, and contraindications. Med Clin North Am. 2002 Nov;86(6):1217-52. doi: 10.1016/s0025-7125(02)00076-7.

  PMID: 12510453 BACKGROUND

• Gangwani MK, Aziz A, Dahiya DS, Nawras M, Aziz M, Inamdar S. History of colonoscopy and technological advances: a narrative review. Transl Gastroenterol Hepatol. 2023 Apr 20;8:18. doi: 10.21037/tgh-23-4. eCollection 2023.

  PMID: 37197258 BACKGROUND

• Church J. Colonoscopy: what are we missing? Surg Oncol Clin N Am. 2014 Jan;23(1):1-9. doi: 10.1016/j.soc.2013.09.001. Epub 2013 Nov 1.

  PMID: 24267161 BACKGROUND

• Greene A, Borgoankar M, Hodgkinson K, Garland C, Bacque L, Pace D. A randomized controlled trial comparing right and left lateral decubitus starting position on outcomes in colonoscopy. Surg Endosc. 2020 Aug;34(8):3656-3662. doi: 10.1007/s00464-020-07661-x. Epub 2020 May 26.

  PMID: 32458286 BACKGROUND

Limitations and Caveats

The relatively small sample size per group may have limited the statistical power to detect subtle differences, and the absence of stratified analyses by hospital with respect to clinical variables (such as age and comorbidities) could have influenced both intubation time and procedure tolerance.

Results Point of Contact

• Title: Roberto Ulises Cruz Neri
• Organization: Hospital Civil Antiguo de Guajadalara "Fray Antonio Alcalde"

robertocruzneri@gmail.com

3311946664

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The main investigators will be in charge of randomizing all the patients ellegible for this protocol, and the care providers and endoscopists will be masked when it comes to knowing to which arm of the study each patient belongs to, untill the moment they need to perform the colonoscopy.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Master in Science, Medical Staff in Coloproctology Department at Hospital Civil Fray Antonio Alcalde

Model Details: multicenter single-blind randomized clinical trial study

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: August 27, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 6, 2025
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Locations

ME (3)