Color III: a multicentre randomised clinical Trial comparing transanal TME versus laparoscopic TME for mid an low rectal cancer, Phase 3

Color III: a multicentre randomised clinical Trial comparing transanal TME versus laparoscopic TME for mid an low rectal cancer, Phase 3 - Color III

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011917

Enrollment

1104

Registered

2017-05-15

Start date

2018-02-12

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal carcinoma C20

Interventions

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 t

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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: 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

Design outcomes

Primary

Measure	Time frame
Primary Outcome: local recurrence after 3 years	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany, Netherlands, Spain, United Kingdom

Contacts

Public ContactAlois Fürst

Klinik für Chirurgie

afuerst@caritasstjosef.de0941 7823311

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026