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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00011917 |
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Date of registration:
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15/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Color III: a multicentre randomised clinical Trial comparing transanal TME versus laparoscopic TME for mid an low rectal cancer, Phase 3
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Scientific title:
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Color III: a multicentre randomised clinical Trial comparing transanal TME versus laparoscopic TME for mid an low rectal cancer, Phase 3 - Color III |
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Date of first enrolment:
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12/02/2018 |
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Target sample size:
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1104 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00011917 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: other; Study design purpose: treatment
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Phase:
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3
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Countries of recruitment
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Germany
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Netherlands
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Spain
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United Kingdom
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Contacts
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Name:
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T W A Koedam
J B Tuynman |
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Address:
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De Boelelaan
1117
Amsterdam
Netherlands |
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Telephone:
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+31204444781 |
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Email:
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t.koedam@vumc.nl |
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Affiliation:
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VU University Medical CentreDepartment of Surgery |
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Name:
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Alois
Fürst |
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Address:
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Landshuter Str. 65
93053
Regensburg
Germany |
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Telephone:
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0941 7823311 |
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Email:
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afuerst@caritasstjosef.de |
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Affiliation:
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Klinik für Chirurgie |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion criteria :
1) Solitary adenocarcinoma rectal cancer within 10 cm from anal verge defined by MRI
2) Stage 1-3 according to the AJCC classification including downstaged tumours based on adequate imaging of the thorax and abdomen
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: 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
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malignant neoplasm of rectum
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rectal carcinoma
C20
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Intervention(s)
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Group 1: 1) the traditional laparoscopic surgical technique through the abdominal wall (TME, total mesorectal excision)
Group 2: 2) the new surgical technique that combines the laparoscopic surgical technique with a transanal approach (TaTME, transanal mesorectal excision).
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Primary Outcome(s)
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Primary Outcome: local recurrence after 3 years
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Secondary Outcome(s)
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Secondary Outcomes: Quality of specimen, involved CRM, morbidity and mortalityresidual mesorectum, DFS, OS, sphincter saving procedures, functional outcome, HrQoL
The following questionnaires are to be completed:
CR 29
QLQ-C30
LAR questionnaire
EQ 5 bow
The questionnaires are on the function of the rectum and pelvic floor muscles shortly before the operation as well as 1,3,6,12,24, and 36 months after the operation.
Three years after the operation a computer tomography or magnetic resonance imaging of the pelvis is performed.
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Source(s) of Monetary Support
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Head of Devision of Surgery, Imperial College London
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Ethics review
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Status: Approved
Approval date: 22/02/2017
Contact:
ethikkommission@ur.de
Ethikkommission der Universität Regensburg
+49-941-9435370
ethikkommission@ur.de
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