Clinical trial · Observational
Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients
Evaluation of Intra- and Peri-operative Complications and Disease-free Survival in Rectal Cancer Patients Undergoing Oncological Resective Surgery and Concomitant Bariatric Surgery
- 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)
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 reported that high visceral adiposity determines an increased risk of recurrence after chemoradiotherapy neoadjuvant. Bariatric surgery has proved to be the best choice for the treatment of morbid obesity and related comorbidities and in this context, the intragastric balloon (IGB) represents a strategy characterized by a low rate of complications and good results in terms of weight loss. Therefore, the need to be able to offer obese patients suffering from rectal cancer the possibility of a better recovery perspective, alongside radical oncological surgery and neoadjuvant treatments, also a bariatric surgery such as the positioning of an intragastric balloon.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity, Morbid | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Surgery-Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIB positioning | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Obese Patients
- description
- Patients candidates for resective surgery for rectal cancer and also elegible for bariatric surgery
- interventionNames
- Procedure: BIB positioning
Primary outcomes (1)
- measure
- Peri-operative complications
- timeFrame
- Intra-operative complications and complications within 30 days from surgery
- description
- Peri-operative complications during rectal cancer surgery
Secondary outcomes (1)
- measure
- Overall survival
- timeFrame
- 3 years after surgery
- description
- Overall survival for patients with rectal cancer underwent resective surgery after BIB positioning
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available