Evaluating surgical outcomes in obese patients with rectal cancer
Evaluation of Intra- and Peri-operative Complications and Disease-free Survival in Rectal Cancer Patients Undergoing Oncological Resective Surgery and Concomitant Bariatric Surgery
This study is testing whether placing an intragastric balloon can help obese patients with rectal cancer have better surgery results and fewer complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT06056726 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of obesity on surgical complications and disease-free survival in patients with locally advanced rectal cancer. It focuses on patients with a BMI between 31 and 55 kg/m2 who are candidates for neoadjuvant therapy and rectal resection. The study will explore the potential benefits of bariatric surgery, specifically the placement of an intragastric balloon, to improve surgical outcomes and reduce complications. By analyzing the relationship between obesity and treatment efficacy, the study seeks to provide insights into better management strategies for this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with locally advanced rectal cancer and a BMI between 31 and 55 kg/m2.
Not a fit: Patients who are not obese, have a BMI outside the specified range, or are not candidates for neoadjuvant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for obese rectal cancer patients.
How similar studies have performed: Previous studies have indicated that bariatric interventions can improve outcomes in obese patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Naples
- Nunzio Velotti — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Mario Musella, MD
- Email: mario.musella@unina.it
- Phone: +390817462880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.