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

NCT ID: NCT06333392

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1070 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-23

Study Completion Date

2027-06-30

Brief Summary

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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:

1. SSLs will be more visible as they "float" on the submucosa and contract into the lumen, while full distension by gas stretches the mucosa, making detection of flat lesions more difficult.
2. Water works like a magnifying lens, making detection and detailed characterisation of lesions easier.
3. uEMR is eased.
4. Improved bowel cleansing

The goal of this clinical trial is to compare colonoscopy outcomes for standard gas (CO2) insufflation and TUC during withdrawal in patients participating in colonoscopy in the Norwegian and Swedish colorectal cancer screening programme after a positive fecal immunochemical test.

The overarching research questions of the present trial is whether colonoscopy outcomes are improved when CO2 insufflation is replaced by TUC during withdrawal and whether the new technique reduces the ecological footprint of the colonoscopy examination.

The project has five main hypotheses:

1. TUC is superior to the standard approach (CO2 withdrawal) regarding detection of proximal SSLs.
2. TUC increases the rate of complete resection of lesions \>= 10mm.
3. TUC reduces the rate of painful colonoscopies and vasovagal reactions.
4. TUC reduces the health care costs by reduced use of single use accessories and reduced number of redundant colonoscopies to obtain polypfree colon.
5. TUC reduces the carbon footprint by reduced use of single use accessories.

If TUC is superior to gas insufflation, the technique may be implemented rapidly since the technique is easy to learn. This study will increase endoscopy competence at participating centres. The centres are involved in national colonoscopy training programs, so the technique will quickly be passed on to other hospitals and screening centres.

The trial can be linked to three of the Global Goals:

* 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.

Detailed Description

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Conditions

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Colorectal Neoplasia Screening Colonoscopy Colorectal Cancer Colorectal Cancer Screening Vasovagal Reaction

Keywords

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colorectal cancer screening screening colonoscopy underwater colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Conventional colonoscopy (CO2) group

this groups receives conventional colonoscopy with CO2 withdrawal

Group Type ACTIVE_COMPARATOR

Conventional colonoscopy

Intervention Type PROCEDURE

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

Total underwater colonoscopy (TUC) group

This group receives total underwater colonoscopy

Group Type EXPERIMENTAL

Total underwater colonoscopy

Intervention Type PROCEDURE

one grooup will be randomized to receive a total underwater colonoscopy

Interventions

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Total underwater colonoscopy

one grooup will be randomized to receive a total underwater colonoscopy

Intervention Type PROCEDURE

Conventional colonoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Individuals with a CRC diagnosis within the last 10 years.
Minimum Eligible Age

55 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role collaborator

University Hospital, Akershus

OTHER

Sponsor Role collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vestre Viken Health Trust, Bærum Hospital

Drammen, , Norway

Site Status RECRUITING

Østfold Hospital Health Trust

Grålum, , Norway

Site Status RECRUITING

Akershus University Hospital Health Trust

Lørenskog, , Norway

Site Status RECRUITING

Ullevål University Hospital Health Trust

Oslo, , Norway

Site Status RECRUITING

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

Gothenburg, , Sweden

Site Status NOT_YET_RECRUITING

Countries

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Norway Sweden

Central Contacts

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Anna Lisa Schult, MD, PhD

Role: CONTACT

Phone: +47 67 80 94 00

Email: [email protected]

Thomas de Lange, MD, associate prof

Role: CONTACT

Email: [email protected]

Facility Contacts

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Anna Lisa Schult, MD PhD

Role: primary

Stine Hvattum, MD

Role: backup

Dung H Nguyen, MD

Role: primary

Jan Henrik Rydning, MD

Role: primary

Stephan Brackmann

Role: backup

Ingrid M Mikalsen, MD

Role: primary

Marte L Høivik, MD PhD

Role: backup

Thomas de Lange, Associate professor

Role: primary

Other Identifiers

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TotalUnderwater_REK577567

Identifier Type: -

Identifier Source: org_study_id