Status:
UNKNOWN
Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients
Lead Sponsor:
Federico II University
Conditions:
Obesity, Morbid
Rectal Cancer
Eligibility:
All Genders
18-70 years
Brief Summary
Obesity worsens treatment outcomes in rectal cancer patients: the local resective approach could in fact be more difficult in obese patients due to limited surgical visibility and it has also been rep...
Detailed Description
Epidemiological data show that obesity is associated with a 30-70% increase in the risk of developing rectal cancer; Obesity could also be associated with a worsening of the tumor prognosis, with an i...
Eligibility Criteria
Inclusion
- Patients with locally advanced rectal cancer in clinical stage II-III according to AJCC-UICC 2017 (candidates for neoadjuvant therapy)
- Patients suffering from I, II and III degree obesity at the same time
- Age between 18 and 70 years old
- BMI between 31 and 55 kg/m2
- Non-Smoking
- Candidates, according to AIOM guidelines, for rectal resection surgical procedures
- Candidates, according to SICOB guidelines, for an intragastric balloon placement procedure
Exclusion
- Age ≤ 18 or ≥ 70 years
- BMI ≤ 30 or ≥ 59 Kg/m2
- Smoker
- Patients with non-locally advanced rectal cancer, not eligible for neoadjuvant therapy
- Histological positivity to Helicobacter pylori
- Presence of ulcerative lesions on EGD
- Previous bariatric surgery treatments
Key Trial Info
Start Date :
February 18 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 18 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06056726
Start Date
February 18 2021
End Date
February 18 2025
Last Update
September 29 2023
Active Locations (1)
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1
Nunzio Velotti
Naples, Italy, 80131