Clinical trial NCT06056726: Evaluation of Surgical Complications and DFS in Obese Rectal Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Rectal Cancer
Surgery-Complications
Keywords: Bariatric Surgery
Oncological surgery
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Peri-operative complications
timeFrame: Intra-operative complications and complications within 30 days from surgery
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years after surgery
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Nunzio Velotti
Study officials:
References: