Comparison of Methods to Distend the Colon During Insertion: CO2, Air Insufflation, Water-aided Colonoscopy

NCT01954862 | Completed

• 1 other identifier: PG. 2013/3403
• Study Type: interventional
• Target: 624
• Locations: 3 countries
• Sites: 3

Brief Summary

Insufflation of the colon, usually with room air, is necessary to distend the lumen for exploration. Carbon dioxide (CO2) insufflation instead of room air insufflation (AI) has been shown to decrease symptoms of abdominal pain or discomfort during the procedure and particularly during the following 24 hours. CO2 is is rapidly absorbed by the intestinal mucosa and exhaled through respiration. AI colonoscopy has usually been the reference standard to compare colonoscopy using CO2 insufflation. In two recent articles AI was compared to either CO2 insufflation and Water-aided colonoscopy (WAC), which entails infusion of water to facilitate insertion to the cecum. WAC can be categorized broadly in Water Immersion (WI) and Water Exchange (WE). In WI water is infused during the insertion phase of colonoscopy, with removal of infused water predominantly during withdrawal. Occasional use of insufflation may be allowed. WE entails complete exclusion of insufflation, removal of residual colonic air pockets and feces, and suction of infused water predominantly during insertion to minimize distention. During the withdrawal phase insufflation is used to distend the colonic lumen. In the WAC arms of the two mentioned articles the insertion method used was WI, with infusion of water at room temperature or at 37°C. During withdrawal, air insufflation or either air or CO2 insufflation were employed. Compared to AI, CO2 insufflation and WI (using room air insufflation or CO2 insufflation during withdrawal) were effective in both studies in decreasing sedation requirement, pain and tolerance scores, with patients' higher willingness to repeat the procedure. Until now no direct comparison has been made within a single study about pain score during colonoscopy using AI, CO2 insufflation, WI/CO2, WE/CO2, WI/AI and WE/AI. In this study we test the hypothesis that, compared to AI, CO2 insufflation and WAC/CO2-AI methods will decrease pain score during colonoscopy, with reduction of sedation requirement, and that WE will achieve the best result. This comparative study has also the aim to test the respective peculiarities of each method.

Conditions

Pain; Colorectal Adenomas; Colorectal Cancer

Keywords

Water-aided colonoscopy; Water Immersion colonoscopy; Water Exchange colonoscopy; Carbon-dioxide colonoscopy; Painless unsedated colonoscopy; Adenoma detection rate; Mean Adenomas per Procedure

Outcome Measures

Primary Outcomes (1)

• Maximum pain score recorded during colonoscopy.

  Pain assessed using a visual analogue scale (VAS) with a score 0=absence of pain, 2=simply "discomfort", 10=the worst possible pain. Before the procedure, an endoscopic nurse will explain the VAS scoring system to the patients. Every 60 seconds during colonoscopy patients will be asked about discomfort or pain. The responses will be recorded, and the maximum pain score noted.

  1 hour

Secondary Outcomes (7)

• Overall pain after the procedure.

  1 hour.

• Cecal intubation rate.

  1 hour

• Cecal intubation time.

  1 hour.

• Total procedure time.

  1 hour.

• Adenoma detection rate.

  15 months.

Other Outcomes (9)

• Position changes.

  1 hour.

• Loop reduction maneuvers.

  1 hour.

• Amount of water used during the procedure.

  1 hour.

Study Arms (6)

Air insufflation method.

ACTIVE COMPARATOR

Colonoscopy performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure.

Other: Air Insufflation method.

CO2 insufflation

EXPERIMENTAL

Colonoscopy performed with CO2 insufflation using the insufflation unit, allowing for washing as needed.

Other: CO2 insufflation

Water Immersion/CO2

EXPERIMENTAL

Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal. Insufflation not used until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if \>3) if the lumen cannot be seen. Withdrawal phase done using CO2 insufflation.

Other: Water Immersion/CO2

Water Exchange/CO2

EXPERIMENTAL

Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned. Withdrawal phase done using CO2 insufflation.

Other: Water Exchange/CO2

Water Immersion/AI

EXPERIMENTAL

Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal. Insufflation not used until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if \>3) if the lumen cannot be seen. Withdrawal phase done using room air insufflation.

Other: Water Immersion/AI

Water Exchange/AI

EXPERIMENTAL

Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned. Withdrawal phase done using room air insufflation.

Other: Water Exchange/AI

Interventions

Air Insufflation method. OTHER

Air Insufflation method.

Air insufflation method.

CO2 insufflation OTHER

CO2 insufflation.

CO2 insufflation

Water Immersion/CO2 OTHER

Water Immersion during insertion, CO2 insufflation during withdrawal.

Water Immersion/CO2

Water Exchange/CO2 OTHER

Water Exchange during insertion, CO2 insufflation during withdrawal.

Water Exchange/CO2

Water Immersion/AI OTHER

Water Immersion during insertion, AI insufflation during withdrawal.

Water Immersion/AI

Water Exchange/AI OTHER

Water Exchange during insertion, AI insufflation during withdrawal.

Water Exchange/AI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive 18 to 85 year-old diagnostic in-patients and outpatients agreeing to start procedure without premedication.

You may not qualify if:

• Patient unwillingness to start the procedure without sedation/analgesia
• previous colorectal surgery
• proctosigmoidoscopy or bidirectional endoscopy
• patient refusal or inability to provide informed consent
• inadequate assumption of bowel preparation
• moderate or severe chronic obstructive pulmonary disease requiring oxygen
• medical history of CO2 retention

Sponsors & Collaborators

• Presidio Ospedaliero Santa Barbara: lead

Study Sites (3)

Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System

Los Angeles, California, 91343, United States

Location

Vìtkovice Hospital

Ostrava, 703 84, Czechia

Location

S. Barbara Hospital

Iglesias, CI, 09016, Italy

Location

Related Publications (8)

• Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.

  PMID: 22569079 BACKGROUND

• Amato A, Radaelli F, Paggi S, Baccarin A, Spinzi G, Terruzzi V. Carbon dioxide insufflation or warm-water infusion versus standard air insufflation for unsedated colonoscopy: a randomized controlled trial. Dis Colon Rectum. 2013 Apr;56(4):511-8. doi: 10.1097/DCR.0b013e318279addd.

  PMID: 23478620 BACKGROUND

• Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.

  PMID: 22898423 BACKGROUND

• Rabenstein T, Radaelli F, Zolk O. Warm water infusion colonoscopy: a review and meta-analysis. Endoscopy. 2012 Oct;44(10):940-51. doi: 10.1055/s-0032-1310157. Epub 2012 Sep 17.

  PMID: 22987214 BACKGROUND

• Leung FW. Water-aided colonoscopy. Gastroenterol Clin North Am. 2013 Sep;42(3):507-19. doi: 10.1016/j.gtc.2013.05.006.

  PMID: 23931857 BACKGROUND

• Wu J, Hu B. The role of carbon dioxide insufflation in colonoscopy: a systematic review and meta-analysis. Endoscopy. 2012 Feb;44(2):128-36. doi: 10.1055/s-0031-1291487. Epub 2012 Jan 23.

  PMID: 22271023 BACKGROUND

• Dellon ES, Hawk JS, Grimm IS, Shaheen NJ. The use of carbon dioxide for insufflation during GI endoscopy: a systematic review. Gastrointest Endosc. 2009 Apr;69(4):843-9. doi: 10.1016/j.gie.2008.05.067. Epub 2009 Jan 18.

  PMID: 19152906 BACKGROUND

• Cadoni S, Falt P, Gallittu P, Liggi M, Mura D, Smajstrla V, Erriu M, Leung FW. Water Exchange Is the Least Painful Colonoscope Insertion Technique and Increases Completion of Unsedated Colonoscopy. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1972-80.e1-3. doi: 10.1016/j.cgh.2015.04.178. Epub 2015 May 5.

  PMID: 25956838 DERIVED

MeSH Terms

Conditions

Pain; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sergio Cadoni, MD

  S. Barbara Hospital, Iglesias (CI), Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsabile Servizio Endoscopia Digestiva

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 7, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

US (1); CZ (1); IT (1)