## Protocol Section
### Identification Module
**NCT ID:** NCT02409979

**Brief Title:** Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes

**Official Title:** Impact of Carbon Dioxide Insufflation and Water Exchange on Post-Colonoscopy Outcomes: A Randomized Controlled Trial

#### Organization Study ID Info
**ID:** PG.2015/3645
#### Organization
**Class:** OTHER
**Full Name:** Presidio Ospedaliero Santa Barbara
#### Secondary ID Infos
**Domain:** Azienda USL 07 Carbonia, Regione Sardegna
**ID:** Delibera 387/C 17 Marzo 2015
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2015-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-11-05

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-11-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-11

**Type:** ACTUAL

#### Start Date
**Date:** 2015-04

**Status Verified Date:** 2015-10

#### Study First Post Date
**Date:** 2015-04-07
**Type:** ESTIMATED
**Study First Submit Date:** 2015-03-23
**Study First Submit QC Date:** 2015-04-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Presidio Ospedaliero Santa Barbara

#### Responsible Party

**Investigator Affiliation:** Presidio Ospedaliero Santa Barbara

**Investigator Full Name:** Sergio Cadoni, M.D.

**Investigator Title:** Responsabile Servizio Endoscopia Digestiva

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Room air insufflated during colonoscopy cannot be completely suctioned, is not easily absorbed and remains in the bowel for quite some time, resulting in prolonged bowel distension with the discomfort of bloating. Sufferers often experience a sensation of fullness and abdominal pressure, relieved only after expulsion of the residual gas, often accompanied by colic pain. This can be a lengthy process, and some patients continue to report pain as long as 24 hours after the procedure. Abdominal discomfort after colonoscopy is an adverse event commonly reported by patients, and definitely associated with the procedure. Published reports show that the use of carbon dioxide (CO2) insufflation significantly decreases bloating and pain up to 24 hours post-procedure. Preliminary results of the investigators' previous study about on-demand sedation colonoscopy in diagnostic patients showed that, compared with CO2 insufflation, the water exchange group (WE, infusion of water to distend the lumen during insertion; suction of infused water, residual air pockets an feces predominantly during insertion) achieved significantly lower real-time insertion pain scores. Moreover (insertion-withdrawal method) WE-CO2 had the lowest bloating scores just after the procedure and at discharge, comparable with those achieved by CO2-CO2. Compared with WE-CO2, the use of WE-air insufflation (AI) showed significantly higher bloating scores just after the procedure and at discharge; compared with CO2-CO2 differences were significant only at discharge. The investigators decided to conduct a prospective randomized controlled trial comparing WE-CO2, WE-AI and CO2-CO2. The investigators will test the hypothesis that patients examined by the combination of WE-CO2 will have significantly lower bloating scores at specific time points after colonoscopy than those examined using WE-AI or CO2-CO2. The investigators will also assess the impact of these three methods on patients comfort and activities in the post-procedure period.

**Detailed Description:** Design: Prospective double blinded two-center randomized controlled trial. Methods: Colonoscopy with CO2 insufflation and water exchange-CO2, water exchange-AI; split-dose bowel preparation; on demand-sedation.

Control method: CO2 insufflation colonoscopy. Study methods: water exchange-CO2 colonoscopy, water exchange-AI colonoscopy.

Population: Consecutive 18 to 80 year-old first-time diagnostic outpatients. After informed consent, assignment to control or study arms based on computer generated randomization list with block allocation and stratification.

### Conditions Module

**Conditions:**

- Abdominal Pain

**Keywords:**

- colonoscopy

- carbon dioxide

- water exchange

- discomfort

- colonoscopy pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

#### Enrollment Info

**Count:** 246

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Colonoscopy performed as usual, with the minimal CO2 insufflation required to aid insertion and adequate distension during withdrawal for exploration. Washing allowed as needed. Considered to be standard procedure.

**Intervention Names:**

- Other: Carbon dioxide method

**Label:** Carbon dioxide method

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for opaque water. Air pockets and residual feces will be always aspirated. Withdrawal phase done using carbon dioxide insufflation.

**Intervention Names:**

- Other: Water Exchange-CO2

**Label:** Water Exchange-CO2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Insufflation not used until the cecum is reached. Infusion of a sufficient amount of water to render the lumen a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for opaque water. Air pockets and residual feces will be always aspirated. Withdrawal phase done using air insufflation.

**Intervention Names:**

- Other: Water Exchange-AI

**Label:** Water Exchange-AI

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Carbon dioxide method

**Description:** Insufflation with CO2 during insertion and withdrawal phases of colonoscopy.

**Name:** Carbon dioxide method

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Water Exchange-CO2

**Description:** Insertion using water exchange, withdrawal using CO2 insufflation.

**Name:** Water Exchange-CO2

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Water Exchange-AI

**Description:** Insertion using water exchange, withdrawal using air insufflation.

**Name:** Water Exchange-AI

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** Cecal intubation will be defined as reaching beyond the ileocecal valve with adequate visualization of the appendix orifice.

**Measure:** Cecal intubation rate.

**Time Frame:** 1 hour.

**Description:** Defined as the time for passage of the colonoscope from the rectum to the cecum.

**Measure:** Cecal intubation time.

**Time Frame:** 1 hour.

**Description:** Total procedure time (including time required for water infusion, polyp resection or biopsy).

**Measure:** Total procedure time.

**Time Frame:** 1 hour.

**Description:** Proportion of subjects with at least one adenoma of any size.

**Measure:** Adenoma detection rate.

**Time Frame:** 9 months.

**Description:** Offered at patient request for a NRS score ≥2. Medications given as per institutional regulation. Dose titrated based on patients' reported real-time pain score, age, weight and comorbidity.

**Measure:** On-demand sedation.

**Time Frame:** 1 hour.

**Description:** Significant oxygen desaturation (\<85% for \>15 seconds) will be recorded.

**Measure:** Oxygen desaturation.

**Time Frame:** 1 hour.

**Description:** Vagal reaction (heart rate \<60 beats per minute accompanied by excessive sweating, nausea and/or vomiting) will be recorded.

**Measure:** Vagal reaction.

**Time Frame:** 1 hour.

#### Primary Outcomes

**Description:** Change of patients' sensation of abdominal bloating. Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients. Measured on an eleven-point Numeric Rating Scale (NRS): 0=none, 10=full bloating. Results will be recorded by telephone recall.

**Measure:** Change in abdominal bloating sensation after colonoscopy.

**Time Frame:** Within the first 24 hours after the procedure.

#### Secondary Outcomes

**Description:** Assessed by blinded observer just after examination, at discharge; and at 1, 3, 6, 12 and 24 hours after the procedure using a questionnaire given to patients. Measured using an eleven-point NRS (0=none, 10=maximum pain). Results will be recorded by telephone recall.

**Measure:** Change in pain score after colonoscopy.

**Time Frame:** Within the first 24 hours after the procedure.

**Description:** Pain assessed using a NRS (0=absence of pain, 2=simply "discomfort", 10=worst pain). Before the procedure, an endoscopic nurse will explain the NRS scoring system to the patients. At irregular intervals during colonoscopy (around 60 seconds) assisting nurse will ask patients about discomfort or pain. The responses will be recorded, and the maximum pain score noted. Colonoscopists not participating in gathering the informations.

**Measure:** Real-time insertion pain.

**Time Frame:** 1 hour.

**Description:** Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients. Results will be recorded by telephone recall.

**Measure:** Number of episodes of incontinence or of soiled underwear experienced in the 6 hours after colonoscopy.

**Time Frame:** 6 hours.

**Description:** Recorded at discharge and assessed post-procedure up to 24 hours using a questionnaire given to patients. Results will be recorded by telephone recall.

**Measure:** Number of flatus episodes post-procedure.

**Time Frame:** 24 hours.

**Description:** Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients. Results will be recorded by telephone recall.

**Measure:** Number of incontinence episodes post-procedure.

**Time Frame:** 6 hours.

**Description:** Recorded at discharge and assessed post-procedure up to 6 hours using a questionnaire given to patients. Results will be recorded by telephone recall.

**Measure:** Toilet use for bowel movement post-procedure.

**Time Frame:** 6 hours.

**Description:** Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not satisfied, 10=very satisfied). Results will be recorded by telephone recall.

**Measure:** Patients' satisfaction with the procedure.

**Time Frame:** 24 hours.

**Description:** Assessed post-procedure after 24 hours using a questionnaire given to patients (0=not willing to repeat, 10=very likely to repeat). Results will be recorded by telephone recall.

**Measure:** Willingness to repeat colonoscopy.

**Time Frame:** 24 hours.

**Description:** Assessed post-procedure after 12 hours using a questionnaire given to patients (0=nothing at all, 10=a lot). Results will be recorded by telephone recall.

**Measure:** Interference of colonoscopy on work/normal activities the same day of the procedure.

**Time Frame:** Up to 12 hours.

**Description:** Work activities missed the day after colonoscopy due to some effect of the procedure (yes, no). Assessed post-procedure after 24 hours using a questionnaire given to patients. Results will be recorded by telephone recall.

**Measure:** Day of work missed the day after the procedure.

**Time Frame:** 24 hours.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* consecutive 18 to 80 year-old first-time diagnostic outpatients agreeing to start procedure without premedication

Exclusion Criteria:

* 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 consumption of bowel preparation
* moderate or severe chronic obstructive pulmonary disease requiring oxygen
* medical history of CO2 retention
* history of inflammatory bowel disease

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** Sepulveda Ambulatory Care Center, VA Greater Los Angeles Healthcare System

**State:** California

**Zip:** 91343

**Location 2:**

**City:** Ostrava

**Country:** Czech Republic

**Facility:** Digestive Diseases Center, Vìtkovice Hospital

**Zip:** 703 84

**Location 3:**

**City:** Iglesias

**Country:** Italy

**Facility:** Digestive Endoscopy Unit, Ospedale S. Barbara

**State:** CI

**Zip:** 09016

#### Overall Officials

**Official 1:**

**Affiliation:** S. Barbara Hospital, Iglesias (CI) Italy

**Name:** Sergio Cadoni, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Sumanac K, Zealley I, Fox BM, Rawlinson J, Salena B, Marshall JK, Stevenson GW, Hunt RH. Minimizing postcolonoscopy abdominal pain by using CO(2) insufflation: a prospective, randomized, double blind, controlled trial evaluating a new commercially available CO(2) delivery system. Gastrointest Endosc. 2002 Aug;56(2):190-4. doi: 10.1016/s0016-5107(02)70176-4.

**PMID:** 12145595

**Citation:** Zubarik R, Fleischer DE, Mastropietro C, Lopez J, Carroll J, Benjamin S, Eisen G. Prospective analysis of complications 30 days after outpatient colonoscopy. Gastrointest Endosc. 1999 Sep;50(3):322-8. doi: 10.1053/ge.1999.v50.97111.

**PMID:** 10462650

**Citation:** de Jonge V, Sint Nicolaas J, van Baalen O, Brouwer JT, Stolk MF, Tang TJ, van Tilburg AJ, van Leerdam ME, Kuipers EJ; SCoPE consortium. The incidence of 30-day adverse events after colonoscopy among outpatients in the Netherlands. Am J Gastroenterol. 2012 Jun;107(6):878-84. doi: 10.1038/ajg.2012.40. Epub 2012 Mar 6.

**PMID:** 22391645

**Citation:** Lee YC, Wang HP, Chiu HM, Lin CP, Huang SP, Lai YP, Wu MS, Chen MF, Lin JT. Factors determining post-colonoscopy abdominal pain: prospective study of screening colonoscopy in 1000 subjects. J Gastroenterol Hepatol. 2006 Oct;21(10):1575-80. doi: 10.1111/j.1440-1746.2006.04145.x.

**PMID:** 16928219

**Citation:** 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

**Citation:** Cadoni S, Falt P, Gallittu P, Liggi M, Smajstrla V, Leung FW. Impact of carbon dioxide insufflation and water exchange on postcolonoscopy outcomes in patients receiving on-demand sedation: a randomized controlled trial. Gastrointest Endosc. 2017 Jan;85(1):210-218.e1. doi: 10.1016/j.gie.2016.05.021. Epub 2016 May 17.

**PMID:** 27207825

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M18311

- Name: Abdominal Pain

- Relevance: HIGH

- As Found: Abdominal Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015746

- Term: Abdominal Pain

### Misc Info Module

- Version Holder: 2024-05-24
