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临床试验/NCT06056726
NCT06056726招募中不适用

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

Federico II University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Peri-operative complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Age ≤ 18 or ≥ 70 years
  • •BMI ≤ 30 or ≥ 59 Kg/m2
  • •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

结局指标

主要结局

Peri-operative complications

时间窗: Intra-operative complications and complications within 30 days from surgery

Peri-operative complications during rectal cancer surgery

次要结局

  • Overall survival(3 years after surgery)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Musella MD

Full Professor of Surgery

Federico II University

研究点 (1)

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