Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients

NCT06056726 | Unknown DMC

• 1 other identifier: RettOb
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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 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

Obesity, Morbid; Rectal Cancer; Surgery-Complications

Keywords

Bariatric Surgery; Oncological surgery

Outcome Measures

Primary Outcomes (1)

• Peri-operative complications

  Peri-operative complications during rectal cancer surgery

  Intra-operative complications and complications within 30 days from surgery

Secondary Outcomes (1)

• Overall survival

  3 years after surgery

Study Arms (1)

Obese Patients

Patients candidates for resective surgery for rectal cancer and also elegible for bariatric surgery

Procedure: BIB positioning

Interventions

BIB positioning PROCEDURE

BIB positioning in obese patients with rectal cancer elegible for neoadjuvant therapy

Obese Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients, with locally advanced rectal cancer in clinical stage II-III, candidates for neoadjuvant therapy, who can underwent BIB positioning during neoadjuvant period to obtain weight loss before resective cancer surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Nunzio Velotti

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Mario Musella, MD

CONTACT

+390817462880; mario.musella@unina.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Surgery

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: February 18, 2021
• Primary Completion: February 18, 2024
• Study Completion: February 18, 2025
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)