跳至主要内容
临床试验/NCT04379830
NCT04379830撤回不适用

The Effect of Preoperative Very Low Energy Diet on Mesorectal Volume in Rectal Cancer Patients: A Pilot Study

McMaster University2 个研究点 分布在 1 个国家开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)

研究概览

简要总结

This pilot study will aim to determine the feasibility, safety, and cost associated with a preoperative VLED for obese rectal cancer patients. Ultimately, the investigators seek to provide evidence that may inform the development of a standardized preoperative weight loss protocol in obese rectal cancer patients.

详细描述

This study is a single center, single-arm prospective cohort pilot study with a primary aim of determining the feasibility, safety, and cost associated with a preoperative VLED for obese rectal cancer patients. Efficacy of preoperative VLED in this study population will be assessed through measures of mesorectal fat volume with MRI at two separate time points, prior to commencing a pre-operative VLED diet and immediately prior to patients undergoing laparoscopic low anterior resection for rectal cancer, to objectively quantify the proportion of mesorectal fat loss in response to VLED. Secondary aims include an assessment of whether preoperative weight loss contributes to improved intraoperative outcomes including operative time, blood loss, and rate of conversion to open procedure. Furthermore, postoperative outcomes including rates of 30-day complication rate, hospital stay, among others will be evaluated.

Optifast 900 will be administered to enrolled patients over a 3-week period immediately prior to their scheduled elective operation date. Compliance will be measured with a food diary. Two MRIs of the rectum will be obtained: one prior to the commencement of VLED and one following the completion of the VLED before the scheduled operation date. The first MRI will be a clinically indicated preoperative staging investigation, while the second MRI will be used purely for research purposes. Patients will be enrolled in an enhanced recovery after surgery (ERAS) for colorectal surgery program. All patients will be followed by their surgeon as per that individual surgeon's postoperative surveillance schedule. At the routine one-month follow-up visit, patients will see the surgeon as well as a study investigator who will complete a standardized follow up questionnaire, focusing on adverse events and functional independence. Research personnel and study investigators will follow patients throughout their postoperative course in hospital and note any secondary outcomes including laboratory tests or adverse events through the electronic patient chart.

Ultimately, the investigators seek to provide evidence that may inform the development of a standardized preoperative weight loss protocol in obese rectal cancer patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • 18 years of age or older
  • BMI greater than or equal to 30kg/m2 and less than or equal to 55kg/m2
  • Patients undergoing elective surgery
  • Documented pathological diagnosis of rectal adenocarcinoma
  • Preoperative staging investigations consistent with stage I, II, and III disease
  • Laparoscopic surgery occurring at St. Joseph's Healthcare Hamilton

排除标准

  • BMI less than 30kg/m2
  • Contraindications to magnetic resonance imaging, general anesthesia, or major colorectal surgery
  • Patient undergoing open surgery
  • Patients undergoing emergency or palliative surgery
  • Preoperative staging investigations consistent with metastatic disease
  • Allergy or contraindication to the use of Optifast
  • Prior pelvic colorectal surgery or bariatric surgery
  • Enrolled in any other clinical trials or prospective studies where similar outcomes are measured
  • Severe, chronic cardiovascular disease (i.e. recent myocardial infarction, unstable angina), renal disease, or hepatic dysfunction
  • Patients with pharmacologically managed diabetes mellitus
  • Pregnant and/or breastfeeding patients
  • Inability to provide informed consent

结局指标

主要结局

Incidence of Treatment-Emergent Adverse Events (safety and tolerability)

时间窗: 2 months

Change in functional independence from the preoperative, pre-VLED period to 1-month postoperatively using the World Health Organization Disability Assessment Schedule 2.0

Change in Mesorectal Fat Volume (efficacy)

时间窗: 1 month

Change in mesolectal fat volume on MRI from prior to 3 weeks of preoperative VLED to immediately following completion of preoperative VLED

Recruitment Target (trial feasibility)

时间窗: 6 months

20 patients over 6 months (3.33 patients per month)

Medication Compliance Rate (trial feasibility)

时间窗: 6 months

Percentage of participants adhering to prescribed Optifast 900 dosages and percentage of Optifast 900 dosages missed by study participants

Follow-Up Rate (trial feasibility)

时间窗: 6 months

Percentage of participants completing follow up appointments, questionnaires, and investigations

次要结局

  • Postoperative Length of Stay(1 month)
  • Postoperative Adverse Events(1 month)
  • Operative Time(1 day)
  • Intraoperative Blood Loss(1 day)
  • Intraoperative Adverse Events(1 day)
  • Cost(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验