Multicentre, randomised controlled trial comparing TRansanal minimal InvAsive Surgery (TAMIS) and endoscopic Submucosal dIsseCtion (ESD) for resection of non-pedunculated rectal lesions.

Colorectal cancer (CRC) is the second most prevalent cancer in the Netherlands,
with 15,000 new cases per year and 5000 colorectal cancer related deaths. The
Dutch National Colorectal Cancer screening program began in 2014 and is
projected to save 1400 lives per year in the short term through early diagnosis
and treatment of cancer. In the longer term it is projected to save an
additional 1000 lives per year through the prevention of cancer by removing
advanced polyps. Two modalities are available for minimally invasive en bloc
resection of large non-pedunculated rectal lesions, including transanal
minimally invasive surgery (TAMIS) and endoscopic submucosal dissection (ESD).
Although both techniques are standard of care in the Netherlands, a direct
randomised comparison between TAMIS and ESD is lacking. Therefore, the choice
for either of both therapies remains operator-dependent instead of
evidence-based.

(Side-study smartwatch: The purpose of this side-study is to further increase
our knowledge on the physical recovery after ESD and TAMIS procedures.
Currently, there is very limited data on the recovery period after ESD/TAMIS.
This study is the first to use a smartwatch to measure the physical activity
after ESD/TAMIS. Monitoring physical activity can give useful long-term outcome
measures that truly reflects a patient*s recovery in their own environment.)
(Side-study MRI: the purpose of this pilot study is to examine whether
submucosal voluven injection can improve standard MRI T-stage accuracy in
non-pedunculated rectal lesions.)

The aim of this study is to compare both procedures with regard to recurrence
rates and complete (R0) resection rate, and to put this into perspective
against the costs and complication rates of both strategies and the burden
perceived by patients in both the short and long term.

(Side-study smartwatch: To compare the physical recovery time after TAMIS and
ESD. Recovery is defined as: Reaching or surpassing 90% of the average step
count measured at baseline for 2 consecutive days.)
(Side-study MRI: investigate the feasibility to detect disruption of the
submucosa of non-pedunculated rectal lesions by MRI after submucosal voluven
injection.)

Multicentre randomised controlled trial

(Side-studies: Side-studies of the TRIASSIC study)

In the TAMIS-arm, resection will be performed using the TAMIS technique,
whereas patients randomised to the ESD-arm will undergo resection using the ESD
technique.

(Side-study smartwatch: 1. Wearing and synchronizing a smartwatch; focused on
measuring the physical activity. 2. Completing a short questionnaire after 4
weeks.)
(Side-study MRI: 1. Rectoscopy prior to ESD for voluven injection. 2.
Abbreviated MRI scan.)

The two resection techniques investigated in this study are standard care in
the Netherlands and thus will not contain any additional risks for
participating patients. Certain procedures that are optional but recommended in
standard care will be performed in all participating patients, including (1)
biopsies of the scar at follow-up colonoscopies. Follow-up colonoscopy is
standard care after resection of an adenoma, and will be performed 6 and 12
months after resection. The questionnaires to evaluate patient burden and
quality of life are grouped as much possible to limit the frequency of
questionnaires. Taken together, neither an unacceptable risk nor a direct
benefit is expected for patients participating in this study. This study will
increase the knowledge on the preferred minimally invasive resection method
that is currently unknown. This is important as the detection rate of these
adenomas has increased dramatically with the introduction of the Dutch CRC
screening program. The study will therefore support an optimal use of health
resources in the future

(Side-study smartwatch: The burden for study participants is estimated to be
low and consists of continuous wearing of the Withings Steel HR® watch,
synchronizing with the HealthMate smartphone application daily and a
questionnaire at the end of the study. There are no health risks or benefits
associated with wearing a smartwatch.)
(Side-study MRI: injection of submucosal fluid is a safe endoscopic procedure
with very low risk of bleeding. It is often used during endoscopic resection of
polips. MRI scan (without contrast) is a non invasive diagnostic modality
without side effects.)