Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy

Study Overview
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Brief Summary
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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
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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).

Official Title
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Multicenter Randomized Trial Comparing Laparoscopy and Laparotomy for Colon Cancer Surgery in Patients Older Than 75 Years

Conditions
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Colonic Cancer

Intervention / Treatment
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* Procedure: Laparotomy
* Procedure: Laparoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 75 years Histologically proven colonic adenocarcinoma (> 15 cm from the anal margin) or precancerous colonic lesion non endoscopically resectable 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) No previous colonic cancer within the 5 last years No peritoneal carcinosis on CT-scan Patient able to fill in an auto-questionnaire alone or with some help MMS (Mini Mental Score) ≥ 15 Given oral consent (formal informed consent is not required by French law for accepted procedures) Exclusion Criteria: Rectal cancer (≤ 15 cm from the anal margin) Locally advanced (cT4) or complicated tumor requiring extended resection or emergency surgery Synchronous colonic cancer - Scheduled need for synchronous intra-abdominal surgery, including surgery for liver metastases Absolute contraindications to general anesthesia or prolonged pneumoperitoneum Patient not able to tolerate colon surgery according to the global comprehensive geriatric assessment Estimated life expectancy less than 6 months Patient under guardianship Other known active cancer (except nonmelanomatous skin cancer) Patient not affiliated to the social security system Previous colonic resection

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparotomy<br>Open surgery | Procedure: Laparotomy<br>* Open surgery<br>* Other names: Open surgery;|
| Experimental: Laparoscopy<br>Minimally invasive surgery | Procedure: Laparoscopy<br>* Minimally invasive surgery<br>* Other names: Minimally invasive surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Surgery, Geriatrics, Digestive Oncology, Colon cancer, Elderly patients, Laparoscopy, Laparotomy, Morbidity