Colectomy for Cancer in the Elderly by Laparoscopy or Laparotomy (CELL)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Colonic Cancer

Treatments: Procedure: Laparotomy; Procedure: Laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03033719

K130901

2016-A00312-49 (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 276 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

276 participants in 2 patient groups

Laparotomy

Active Comparator group

Description:

Open surgery

Treatment:

Procedure: Laparotomy

Laparoscopy

Experimental group

Description:

Minimally invasive surgery

Treatment:

Procedure: Laparoscopy