Total Underwater Colonoscopy (TUC) for Improved Colorectal Cancer Screening: A Randomized Controlled Trial

NCT06333392 | Recruiting DMC

• 1 other identifier: TotalUnderwater_REK577567
• Study Type: interventional
• Target: 1,070
• Locations: 2 countries
• Sites: 5

Brief Summary

Colorectal cancer (CRC), the third most diagnosed cancer and second most common cause of cancer death. CRCs develop from precursors like adenomas (about 70% of CRCs) or serrated lesions (SSLs) (about 25-30% of CRCs). Colonoscopy is the cornerstone in CRC screening, in screening programmes often as a work-up examination after a positive primary screening test such as faecal immunochemical test (FIT). Norway and Sweden have recently launched a nationwide faecal haemoglobin CRC screening programmes. Recently, both a Dutch and an Austrian study showed that SSL detection rate (SSLDR) is inversely correlated to CRC at follow-up. Consequently, improved SSLDR can reduce the risk of post-colonoscopy CRC. SSLs are typically located in the right colon. They are flat, with indistinctive boarders, and consequently easily missed or incompletely resected. A Norwegian study showed incomplete resection of 40% of proximal SSLs. The prevalence of SSLs is higher in women than in men, with women being on a threefold risk of developing CRC from SSLs. It seems like post-colonoscopy CRC more often is caused by SSLs than by adenomas. Total underwater colonoscopy (TUC) is a technique replacing conventional CO2 insufflation by water infusion to distend the lumen and visualise the mucosa during withdrawal of the colonoscope and simultaneously removal of water. There are several reasons to advocate TUC:

• Good health and well-being: The increased detection and improved complete removal of sessile serrated lesions can subsequently decrease the risk of CRC and CRC mortality during follow-up. TUC will probably reduce the rate of painful procedures and vasovagal reactions and thus increase the acceptance of a screening programme. Consequently, the project can contribute significantly to improve screening effectiveness in Norway and Sweden, particularly in women (women have a higher risk for SSLs and a higher risk of colorectal cancer developing from this type of precursor).
• Gender equality: Women have a similar lifetime risk for CRC as men but less benefit of screening regardless of whether they are screened by sigmoidoscopy, FIT or colonoscopy. The reason is probably missed sessile serrated lesions in the proximal colon. If TUC improves SSLDR and complete lesion resection, this may lead to an equal benefit from CRC screening for women and men. Women have also a higher risk of discomfort and pain during colonoscopy than men. It has been shown that women prefer non-invasive screening modalities, potentially to avoid pain during colonoscopy, even if colonoscopy may be the most beneficial screening method for women. If TUC reduces the rate of painful colonoscopies, it can reduce women's barriers to attend screening.
• Responsible consumption and production: The TUC technique will also reduce the ecological footprint of colonoscopy activity due to reduced consumption of single use accessories and reduced number of colonoscopies to achieve polyp free colon. Furthermore, the cost for the health care system will be substantially reduced.

Conditions

Colorectal Cancer; Colorectal Cancer Screening; Vasovagal Reaction; Screening Colonoscopy; Colorectal Neoplasia

Keywords

colorectal cancer screening; screening colonoscopy; underwater colonoscopy

Outcome Measures

Primary Outcomes (1)

• Proximal sessile serrated lesion detection rate

  The proportion of colonoscopies where at least one proximal SSL is detected

  when histopathology report is clear, about 4 weeks after colonoscopy

Secondary Outcomes (11)

• Complete resection rate for lesions > 10mm

  4 weeks after colonoscopy

• Rate of painful procedures and vasovagal reactions

  during and immediately after colonoscopy

• Leakage after colonoscopy

  Questionnaire 1-7 days after colonoscopy

• Detection rate for other neoplasia than SSL

  about 4 weeks after colonoscopy

• Withdrawal time

  immediately after colonoscopy

Study Arms (2)

Conventional colonoscopy (CO2) group

ACTIVE COMPARATOR

this groups receives conventional colonoscopy with CO2 withdrawal

Procedure: Conventional colonoscopy

Total underwater colonoscopy (TUC) group

EXPERIMENTAL

This group receives total underwater colonoscopy

Procedure: Total underwater colonoscopy

Interventions

Conventional colonoscopy PROCEDURE

one group will be randomized to undergo a conventional colonoscopy with CO2 withdrawal

Conventional colonoscopy (CO2) group

Total underwater colonoscopy PROCEDURE

one grooup will be randomized to receive a total underwater colonoscopy

Total underwater colonoscopy (TUC) group

Eligibility Criteria

• Age: 55 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All individuals referred to colonoscopy after a positive FIT screening at the participating screening centres

You may not qualify if:

• Individuals with a CRC diagnosis within the last 10 years.

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• Ullevaal University Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• Ostfold Hospital Trust: collaborator
• University Hospital, Akershus: collaborator

Study Sites (5)

Vestre Viken Health Trust, Bærum Hospital

Drammen, 3004, Norway

RECRUITING

Østfold Hospital Health Trust

Grålum, 1714, Norway

RECRUITING

Akershus University Hospital Health Trust

Lørenskog, 1478, Norway

RECRUITING

Ullevål University Hospital Health Trust

Oslo, 0424, Norway

RECRUITING

Sahlgrenska University Hospital, Gothenburg, Region Västra Götaland, Sweden, Department of Medicine, Geriatrics and Emergency Care Mölndal

Gothenburg, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anna Lisa Schult, MD, PhD

CONTACT

+47 67 80 94 00; anschu@vestreviken.no

Thomas de Lange, MD, associate prof

CONTACT

thomas.de.lange@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Access Criteria: Access to research data for external investigators, or use outside of the current protocol, will require approval from the Norwegian Regional Committee for Medical and Health Research Ethic. Research data are not openly available because of the principles and conditions set out in articles 6\[1\] (e) and 9 \[2\] (j) of the General Data Protection Regulation (GDPR).

Locations

SE (1); NO (4)