Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy

Not Applicable

• Conditions: Colonic Cancer
• Interventions: Procedure: Laparotomy; Procedure: Laparoscopy

• Registration Number: NCT03033719
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-27
• Study Start: 2017-07-04
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-12
• Primary Completion: 2020-04
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 276

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparotomy	Laparotomy	Open surgery
Laparoscopy	Laparoscopy	Minimally invasive surgery

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Postoperative mortality	Evaluated at 30 days and at 90 days after the surgery	Death from any 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)
Pathological evaluation of mesocolic resection quality	At surgery	Quality of surgical resection : Pathological evaluation of mesocolic resection quality
Rate of readmission	Within the 30 days after discharge of the patient	Defined as any rehospitalization whatever the cause
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)
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)

Trial Locations

Locations (1)

Groupe Hospitalier Pitié Salpêtrière; 🇫🇷 Paris, France