Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00312-49 | Other Identifier | ID RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparotomy | Active Comparator | Open surgery |
|
| Laparoscopy | Experimental | Minimally invasive surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparotomy | Procedure | Open surgery |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Global postoperative morbidity in both arms | 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 | At 30 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative mortality | Death from any cause | Evaluated at 30 days and at 90 days after the surgery |
| Rate of readmission | Defined as any rehospitalization whatever the cause |
| Measure | Description | Time Frame |
|---|---|---|
| To establish a specific molecular classification of colon cancer in the elderly from expression chips | 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) | within the 15 years after the tumor sampling |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilles MANCEAU, M.D., PhD., | Contact | 00331 42 17 56 51 | gilles.manceau@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Gilles MANCEAU, M.D., PhD., | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Pitié Salpêtrière | Recruiting | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31801485 | Derived | Manceau G, Brouquet A, Chaibi P, Passot G, Bouche O, Mathonnet M, Regimbeau JM, Lo Dico R, Lefevre JH, Peschaud F, Facy O, Volpin E, Chouillard E, Beyert-Berjot L, Verny M, Karoui M, Benoist S. Multicenter phase III randomized trial comparing laparoscopy and laparotomy for colon cancer surgery in patients older than 75 years: the CELL study, a Federation de Recherche en Chirurgie (FRENCH) trial. BMC Cancer. 2019 Dec 4;19(1):1185. doi: 10.1186/s12885-019-6376-8. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007813 | Laparotomy |
| D061887 | Conversion to Open Surgery |
| D010535 | Laparoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Laparoscopy | Procedure | Minimally invasive surgery |
|
|
| Within the 30 days after discharge of the patient |
| Number of examined lymph nodes | Quality of surgical resection : Number of examined lymph nodes | At surgery |
| Type of resection (R0 or R1) | Quality of surgical resection : Type of resection (R0 or R1) | At surgery |
| Pathological evaluation of mesocolic resection quality | Quality of surgical resection : Pathological evaluation of mesocolic resection quality | At surgery |
| Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-C30) | 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-CR29) | Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29) | At randomization and three months postoperatively |
| Mini Mental State (MMS) Examination or Folstein test | Evolution of geriatric scores : The Mini Mental State (MMS) Examination or Folstein test; (Comprehensive geriatric assessment performed by a geriatrician on each site) | Before randomization and three months postoperatively |
| Katz Activities of Daily Living (ADL) scale | Evolution of geriatric scores :The Katz Activities of Daily Living (ADL) scale (Comprehensive geriatric assessment performed by a geriatrician on each site) | Before randomization and three months postoperatively |
| Geriatric Depression Scale (GDS) | Evolution of geriatric scores :The Geriatric Depression Scale (GDS) (Comprehensive geriatric assessment performed by a geriatrician on each site) | Before randomization and three months postoperatively |
| Timed Get-up-and-go (TGUG) | Evolution of geriatric scores :The Timed Get-up-and-go (TGUG) test (Comprehensive geriatric assessment performed by a geriatrician on each site) | Before randomization and three months postoperatively |
| To establish associations between molecular subtypes, the clinical and histological factors and relevant genetic alterations | 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) | within the 15 years after the tumor sampling |
| To establish a possible link between these molecular subtypes and overall survival of patients | 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) | within the 15 years after the tumor sampling |
| To compare our molecular classification with the different classifications already published in the literature on colorectal cance | 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) | within the 15 years after the tumor sampling |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D003933 | Diagnosis |