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临床试验/NCT06359730
NCT06359730已完成不适用

Incidence, Risk Factors Of Low Anterior Resection Syndrome And Validation Of LARS Score Among Egyptian Patients

Zagazig University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
type of surgery

研究概览

简要总结

Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.

With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age more than 18
  • Diagnosed patients with rectal adenocarcinoma and who received low anterior resection with anastomosis creation or after a minimum 6 months interval after stoma reversal.
  • Tumors of the rectum (2-15 cm) from anal verge

排除标准

  • • cognitive dysfunction
  • Having a history of inflammatory bowel disease or any disease with bowel function impairment namely, Crohn's disease, irritable bowel syndrome, ulcerative colitis or others.
  • Age less than 18
  • Metastatic cancer or tumor recurrence
  • Rectal tumors within 2 cm from anal verge( abdominoperineal)

结局指标

主要结局

type of surgery

时间窗: from 2017 to 2022

from records; surgery was open or laparoscopic

site of tumor

时间窗: from 2017 to 2022

tumor site was determined in Cm from anal verge by colonoscopy

site of anastmosis

时间窗: from 2017 to 2022

site of anastmosis after resection was recorded as colo-rectal or colo-anal

type of meso-rectal excision

时间窗: from 2017 to 2022

excision of meso-rectum was recorded if it was partial or complete

age

时间窗: from 2017 to 2022

age of the patients in years was recorded from patient records

sex

时间窗: from 2017 to 2022

sex of patients was recorded from patient records

type of anastmosis

时间窗: from 2017 to 2022

type of anastmosis(hand sewen or stappled) obtained from records

LARS score

时间窗: from 2017 to 2022

obtained by LARS questionnaire filled by the patient during follow up, it was formed of five questions with different scores on answer choices, interpretaion (0-20) means no LARS, (21- 29) means minor LARS, (30-42) means major LARS

medical disease

时间窗: from 2017 to 2022

medical disease like diabetes and hypertension was recorded from patient records

adjuvant therapy

时间窗: from 2017 to 2022

it was recorded from patients records if he\\she had chemo- or radiotherapy post-operatively

neoadjuvant therapy

时间窗: from 2017 to 2022

history of neoadjuvant therapy before surgery was obtained from patients records

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Reham Zakaria Mohamed Ahmed

Principal Investigator

Zagazig University

研究点 (1)

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