Colonic Cancer
Conditions
Keywords
Colorectal Surgery, Geriatrics, Digestive Oncology, Colon cancer, Elderly patients, Laparoscopy, Laparotomy, Morbidity
Brief summary
The purpose of this study is to compare the postoperative global morbidity between patients who have been operated on for a colon cancer by laparotomy and those operated on by laparoscopy
Detailed description
The present study is a national, multicenter, open-label randomized, 2-arm superiority trial. Patients aged 75 years or older with uncomplicated colonic cancer or precancerous colonic lesion non-endoscopically resectable, will be randomized to either colectomy by laparoscopy or laparotomy. All patients that might be included will have a comprehensive geriatric assessment performed within the 30 days before randomization with the following scores: MMS (Mini Mental Score), ADL scale (Activities of Daily Living), IADL scale (Instrumental Activities of Daily Living), GDS (Geriatric Depression Scale) and TGUG test (Timed Get-Up-and-Go test).
Interventions
PROCEDURELaparotomy
Open surgery
PROCEDURELaparoscopy
Minimally invasive surgery
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 75 years 2. Histologically proven colonic adenocarcinoma (\> 15 cm from the anal margin) or precancerous colonic lesion non endoscopically resectable 3. Uncomplicated colonic tumor (no preoperative suspicion of invasion of adjacent structures as assessed by CT-scan (cT4), no tumoral perforation, or tumoral obstruction, or abscess, or hemorrhage) 4. No previous colonic cancer within the 5 last years 5. No peritoneal carcinosis on CT-scan 6. Patient able to fill in an auto-questionnaire alone or with some help 7. MMS (Mini Mental Score) ≥ 15 8. Given oral consent (formal informed consent is not required by French law for accepted procedures)
Exclusion criteria
1. Rectal cancer (≤ 15 cm from the anal margin) 2. Locally advanced (cT4) or complicated tumor requiring extended resection or emergency surgery 3. Synchronous colonic cancer 4. \- Scheduled need for synchronous intra-abdominal surgery, including surgery for liver metastases 5. Absolute contraindications to general anesthesia or prolonged pneumoperitoneum 6. Patient not able to tolerate colon surgery according to the global comprehensive geriatric assessment 7. Estimated life expectancy less than 6 months 8. Patient under guardianship 9. Other known active cancer (except nonmelanomatous skin cancer) 10. Patient not affiliated to the social security system 11. Previous colonic resection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global postoperative morbidity in both arms | At 30 days after the surgery | Postoperative morbidity is defined as any surgical or medical complications occurring up to 30 days after surgery. It will be collected using a standardized collection form during hospitalization and eventual subsequent consultations in case of patient discharge before then |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological evaluation of mesocolic resection quality | At surgery | Quality of surgical resection : Pathological evaluation of mesocolic resection quality |
| Mini Mental State (MMS) Examination or Folstein test | Before randomization and three months postoperatively | Evolution of geriatric scores : The Mini Mental State (MMS) Examination or Folstein test; (Comprehensive geriatric assessment performed by a geriatrician on each site) |
| Katz Activities of Daily Living (ADL) scale | Before randomization and three months postoperatively | Evolution of geriatric scores :The Katz Activities of Daily Living (ADL) scale (Comprehensive geriatric assessment performed by a geriatrician on each site) |
| Geriatric Depression Scale (GDS) | Before randomization and three months postoperatively | Evolution of geriatric scores :The Geriatric Depression Scale (GDS) (Comprehensive geriatric assessment performed by a geriatrician on each site) |
| Timed Get-up-and-go (TGUG) | Before randomization and three months postoperatively | Evolution of geriatric scores :The Timed Get-up-and-go (TGUG) test (Comprehensive geriatric assessment performed by a geriatrician on each site) |
| Postoperative mortality | Evaluated at 30 days and at 90 days after the surgery | Death from any cause |
| Rate of readmission | Within the 30 days after discharge of the patient | Defined as any rehospitalization whatever the cause |
| Number of examined lymph nodes | At surgery | Quality of surgical resection : Number of examined lymph nodes |
| Type of resection (R0 or R1) | At surgery | Quality of surgical resection : Type of resection (R0 or R1) |
| Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30) | At randomization and three months postoperatively | Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30) |
| Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29) | At randomization and three months postoperatively | Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29) |
Other
| Measure | Time frame | Description |
|---|---|---|
| To establish a possible link between these molecular subtypes and overall survival of patients | within the 15 years after the tumor sampling | To establish a possible link between these molecular subtypes and overall survival of patients. (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort) |
| To compare our molecular classification with the different classifications already published in the literature on colorectal cance | within the 15 years after the tumor sampling | To compare our molecular classification with the different classifications already published in the literature on colorectal cancer (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort) |
| To establish a specific molecular classification of colon cancer in the elderly from expression chips | within the 15 years after the tumor sampling | To establish a specific molecular classification of colon cancer in the elderly from expression chips (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort) |
| To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations | within the 15 years after the tumor sampling | To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations (Ancillary studies will be conducted from formalin fixed paraffin embedded (FFPE) tumor samples from our cohort) |
Countries
France
Contacts
Primary ContactGilles MANCEAU, M.D., PhD.,
Outcome results
None listed