NCT03033719

Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Colonic Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparotomy	Open surgery
PROCEDURE	Laparoscopy	Minimally invasive surgery

Timeline

• Start date: 2017-07-04
• Primary completion: 2020-04-01
• Completion: 2020-06-01
• First posted: 2017-01-27
• Last updated: 2018-01-12

Locations

1 site across 1 country: France