Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients

Phase

N/A

Condition

Rectal Cancer

Rectal Disorders

Colon Cancer

Treatment

BIB positioning

Clinical Study ID

NCT06056726

RettOb

Ages 18-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients with locally advanced rectal cancer in clinical stage II-III according toAJCC-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 placementprocedure

Exclusion

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

Study Design

BIB positioning

February 18, 2021

February 18, 2025

Study 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.

Connect with a study center

Nunzio Velotti
Naples, 80131
Italy
Active - Recruiting

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