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临床试验/CTRI/2022/09/045958
CTRI/2022/09/045958招募中不适用

Outcomes of Pelvic Exenteration in Rectal cancer: An Institutional study

Malabar Cancer Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年9月30日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Overall survival

研究概览

简要总结

OUTCOMES OF PELVIC EXENTERATION IN RECTAL CANCER: AN INSTITUTIONAL STUDY

  1. RESEARCH QUESTION

What are the factors predicting treatment outcomes and long term survival following pelvic exenteration for rectal cancer?

  1. AIMS AND OBJECTIVES

  2. AIM To evaluate long term survival and postoperative outcomes following pelvic exenteration for locally advanced primary and recurrent rectal cancer

  3. PRIMARY OBJECTIVE To determine the overall survival and disease free survival  To determine the morbidity and mortality rates following pelvic exenteration SECONDARY OBJECTIVE To determine prognostic factors associated with postoperative outcomes and survival.

  4. METHODOLOGY

  5. STUDY SETTING

Department of Surgical Oncology, Malabar Cancer Center, Thalassery

  1. STUDY DESIGN

Retrospective

  1. STUDY POPULATION

All patients with locally advanced primary and recurrent rectal cancer who underwent pelvic exenteration in MCC during the study period

  1. STUDY PERIOD

January 2009 - December 2020

  1. INCLUSION CRITERIA
  • Locally advanced or recurrent adenocarcinoma of rectum requiring pelvic exenteration
  1. EXCLUSION CRITERIA
  • Patients with second malignancy(except non-melanomatous skin cancer)
  1. DATA COLLECTION METHOD & SOURCE

Clinical data, treatment details and follow up data will be collected from the medical records division, MCC.

  1. DEFINITIONS
Overall survival

Duration from date of registration to date of death or last follow up

|Disease free survival

Duration from date of completion of surgery to date of recurrence or last follow up

|Posterior pelvic exenteration

Resection of rectum, anal canal and uterus

|Total pelvic exenteration

Resection of rectum, anal canal, uterus and bladder

|Extended pelvic exenteration

Resection of structures additional to total exenteration like piriformis, sacrum

|Customized pelvic exenteration

Resection extent lesser than posterior or total exenteration like prostate, vaginal wall

研究设计

研究类型
Observational

入排标准

年龄范围
25.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients with rectal cancer who underwent pelvic exenteration in Malabar Cancer Center during the period Jan 2009- Dec 2020.

排除标准

  • Second malignancy except non-melanomatous skin cancers.

结局指标

主要结局

Overall survival

时间窗: overall survival and disease-free survival at 3 yrs and 5 yrs

Disease free survival

时间窗: overall survival and disease-free survival at 3 yrs and 5 yrs

Recurrence rates will be assessed

时间窗: overall survival and disease-free survival at 3 yrs and 5 yrs

次要结局

  • morbidity and mortality rates(30 day morbidity and 30 day mortality)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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