Clinical trial · Interventional
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
NCT03033719CI-TRIAL-00031160CELLunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Cancer | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopy | Procedure | — | UNRESOLVED |
| Laparotomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Laparotomy
- description
- Open surgery
- interventionNames
- Procedure: Laparotomy
- type
- EXPERIMENTAL
- label
- Laparoscopy
- description
- Minimally invasive surgery
- interventionNames
- Procedure: Laparoscopy
Primary outcomes (1)
- measure
- Global postoperative morbidity in both arms
- timeFrame
- At 30 days after the surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDManceau G, Brouquet A, Chaibi P, Passot G, Bouche O, Mathonnet M, Regimbeau JM, Lo Dico R, Lefevre JH, Peschaud F, Facy O, Volpin E, Chouillard E, Beyert-Berjot L, Verny M, Karoui M, Benoist S. Multicenter phase III randomized trial comparing laparoscopy and laparotomy for colon cancer surgery in patients older than 75 years: the CELL study, a Federation de Recherche en Chirurgie (FRENCH) trial. BMC Cancer. 2019 Dec 4;19(1):1185. doi: 10.1186/s12885-019-6376-8. PMID 31801485