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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
Open surgery
Minimally invasive surgery
Groupe Hospitalier Pitié Salpêtrière
Paris, France
RECRUITINGGlobal 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
Time frame: At 30 days after the surgery
Postoperative mortality
Death from any cause
Time frame: Evaluated at 30 days and at 90 days after the surgery
Rate of readmission
Defined as any rehospitalization whatever the cause
Time frame: Within the 30 days after discharge of the patient
Number of examined lymph nodes
Quality of surgical resection : Number of examined lymph nodes
Time frame: At surgery
Type of resection (R0 or R1)
Quality of surgical resection : Type of resection (R0 or R1)
Time frame: At surgery
Pathological evaluation of mesocolic resection quality
Quality of surgical resection : Pathological evaluation of mesocolic resection quality
Time frame: 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)
Time frame: At randomization and three months postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
Health-related quality of life : Quality of Life Questionnaires (EORTC QLQ-CR29)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Before randomization and three months postoperatively