In attempt to improve the quality of the TME procedure in low rectal cancer and further improve morbidity the TaTME has been developed, in which the rectum is dissected transanally according to TME principles. First series have been described since…
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Source
Brief title
Condition
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the percentage of patients with local recurrence after
3-years follow-up.
(defined as local macroscopic tumour assessed by colono- or proctoscopy,
(PET-)CT-scan or MRI of the pelvis)
Secondary outcome
Pathological
• Quality of specimen (as proposed and published by Quirke et al.)
• Involved circumferential resection margin
• Distal resection margin (defined as distance in cm from distal border of the
tumour to distal resection surface)
• Translational research will be performed on predictive/prognostic biomarkers
and imaging methods.
Clinical
• Length of hospital stay postoperatively (calculated as time from surgery to
discharge in days)
• Morbidity within 28 days after surgery and within 90 days (graded by
Clavien-Dindo Classification)
• Mortality within 28 days after surgery and within 90 days
• Local recurrence at three and five years (defined as cancer recurrence within
the pelvic and perineal area)
• Disease-free survival at three and five years (calculated as time from
surgery to last follow- up or date of recurrence)
• Overall survival at three and five years (calculated as time from surgery to
last follow- up or death)
Quality of life
• Percentage of sphincter saving procedures (defined as colostomy percentage at
1 year postoperatively)
• Postoperative health related quality of life (quality adjusted life years)
and functional outcome (measured with EORTC QLQ-CR29 and C30, EQ5D and LARS
score).
Background summary
The quality of rectal cancer surgery has improved during the last decades with
the total mesorectal excision (TME) technique, adaptation of laparoscopic
surgery and extralevatory approach for abdominoperineal resection (APR).
Nevertheless, surgery for mid and low rectal cancer is associated with relative
high rates of incomplete mesorectal excisions and relative high rates of
circumferential resection margin (CRM) involvement resulting in significant
number of local recurrences. Moreover, patients with mid and low rectal cancer
suffer from high rates of morbidity, permanent colostomies and significant
impairment of quality of life.
The transanal TME (TaTME) has been developed with use of laparoscopic single
port platforms to improve the quality of the TME procedure in mid and low
rectal cancer. In TaTME, the tumour is distally approached through the anus
with laparoscopic instruments.
Published cohort studies have shown that the TaTME procedure is safe and is
associated with low conversion rate and less permanent colostoma. Before
adaptation of the TaTME as standard surgical therapy for mid an low rectal
cancer, a well-designed study is essential to demonstrate its oncological
efficacy and safety in a multicentre randomised setting.
Study objective
In attempt to improve the quality of the TME procedure in low rectal cancer and
further improve morbidity the TaTME has been developed, in which the rectum is
dissected transanally according to TME principles. First series have been
described since 2010 and although randomised evidence is still lacking this new
technique has shown to be feasible and safe. The rectum including the total
mesorectum is mobilised transanally in a reversed way with minimally invasive
surgery including high quality imaging techniques.
The TaTME technique for mid and low rectal cancer has shown to have potential
benefits: less conversions in the majority of patients and more sphincter
saving rectal resections without compromising oncological outcomes.
We propose to evaluate the TaTME technique compared with conventional
laparoscopic rectal resection for patients with mid and low rectal cancer in an
international randomised trial: the COLOR III trial.
Study design
The COLOR III trial is an international multicentre, non-inferior, randomised
study comparing short- and long term outcomes of TaTME and laparoscopic TME for
rectal cancer.
The study will include a quality assessment phase before randomisation to
ensure required competency level and uniformity of the new TaTME technique and
the laparoscopic TME. During the trial the clinical data will be reviewed
centrally to ensure uniform quality.
In laparoscopic TME the percentage of local recurrence is estimated 5%. A local
recurrence increase of 4% is believed to be inferior. Based on this difference,
sample size calculation has been done with a one-sided level of significance of
2,5% and a power of 80%.A total of 1104 patients is needed, 735 patients in the
TaTME arm and 369 patients in the laparoscopic TME arm.
In this sample size calculation, additional postrandomisation analyses
(drop-out, cross-over total 5%), is taken into account.
Randomisation will be stratified for
T3a and less / T3b and more
Downstaged with chemoradiotherapy: yes / no / NA
Preoperative radiotherapy: yes / no
Height of the tumour: 0-2.0cm / 2.1-5.0cm / 5.1-10cm
Gender: male / female
BMI <= 30.0 / BMI > 30.0
The randomisation will be executed in such a way that concealment of allocation
for the indicating surgeon is guaranteed.
Intervention
Transanal Total Mesorectal Excision.
Study burden and risks
Patients participating in this study have low burden and low risk on
complications related to the trial. The follow-up scheme is almost similar to
the regular scheme after rectal cancer surgery, except from the questionnaires.
An pelvic CT or pelvic MRI is needed at 3 years conform international
guidelines.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
1) Solitary adenocarcinoma rectal cancer within 10 cm from anal verge defined
by MRI
2) Stage 1-3 based on AJCC classification including downstaged tumours
3) Intention for LAR with colorectal anastomosis or with coloanal anastomosis
4) Suitable for elective laparoscopic surgical resection
5) Informed consent according to local requirements
Exclusion criteria
1) T3 tumour with margins less than 1 mm to the mesorectal fascia or T4 tumour,
determined by MRI-scan (staged after (chemo)radiotherapy if applicable)
2) Intention for complete intersphincteric APR with coloanal anastomosis
3) Malignancy other than adenocarcinoma at histological examination
4) Patients under 18 years of age
5) Pregnancy
6) Previous prostate or rectal surgery (excluding local excision)
8) Signs of acute intestinal obstruction
9) Multiple colorectal tumours
10) Familial Adenomatosis Polyposis Coli (FAP), Hereditary Non-Polyposis
Colorectal Cancer (HNPCC), active Crohn*s disease or active ulcerative colitis
11) Planned synchronous abdominal organ resections
14) Other malignancies in medical history, except adequately treated
basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
15) Absolute contraindication to general anaesthesia or prolonged
pneumoperitoneum, as severe cardiovascular or respiratory disease (ASA class >
III)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL54598.029.15 |