Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients

Rectal Cancer Clinical Trial

Official title:

Evaluation of Intra- and Peri-operative Complications and Disease-free Survival in Rectal Cancer Patients Undergoing Oncological Resective Surgery and Concomitant Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056726
• Other study ID #: RettOb
• Status: Recruiting
• Start date: February 18, 2021
• Est. completion date: February 18, 2025

Study information

• Verified date: September 2023
• Source: Federico II University
• Contact: Mario Musella, MD
• Phone: +390817462880
• Email: mario.musella[@]unina.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 increased risk of recurrence and increased mortality. From this point of view, recent studies have shown that a BMI ≥ 30 kg/m2 is associated with higher oncological and functional risks in patients with locally advanced rectal cancer, with lower response rates to neoadjuvant treatment and a less frequent preservation of the anal sphincter.

Obesity also worsens treatment outcomes: 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.

The most recent studies on the subject have shown that IGBs are effective in producing weight loss ranging from 6% to 15% compared to 1% -5% produced by lifestyle interventions alone Therefore, the need to be able to offer obese patients suffering from rectal cancer the possibility of a better recovery perspective (reduction of intra- and peri-operative complications, increased disease-free survival and lower risk of long-term recurrence) is underlined. ), alongside radical oncological surgery and neoadjuvant treatments, also a bariatric surgery such as the positioning of an intragastric balloon.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 18, 2025
• Est. primary completion date: February 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid
• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Nunzio Velotti	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-operative complications	Peri-operative complications during rectal cancer surgery	Intra-operative complications and complications within 30 days from surgery
Secondary	Overall survival	Overall survival for patients with rectal cancer underwent resective surgery after BIB positioning	3 years after surgery