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临床试验/NCT05893095
NCT05893095已完成不适用

Evaluation of Laparoscopic Peritoneal Lavage for Perforated Diverticulitis: A National Registry - Based Study

Uppsala University Hospital0 个研究点目标入组 52,863 人开始时间: 2014年7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
52,863
主要终点
Preferred operation for acute colonic diverticular disease

研究概览

简要总结

The goal of this observational study is to study the emergency surgical treatment of diverticular disease in Sweden outside clinical trials. The main questions it aims to answer are:

  • Which is the preferred surgical method of acute diverticular disease in Sweden?
  • Which are the short and long-term outcomes of the different surgical methods?

Researchers will compare the different methods to see if there is a surgical operation that is superior for the treatment of acute diverticulitis.

详细描述

A retrospective study of patients who were admitted to a Swedish hospital between 1st July 2014 and 31st December 2020 with an ICD-10 code for diverticular disease of the large intestine (K57.2- K57.9) will be included. Patients who underwent procedures relevant to diverticulitis will be identified and therefore will be included. Procedures will be grouped into two categories: Laparoscopic peritoneal lavage (Group I), and sigmoid resection with or without stoma (Group II).

The cohort will be studied from 1st January 1997 until the index date aiming to assess comorbidities, previous abdominal surgeries, and admissions for diverticular disease. A Charlson Comorbidity Index (CCI) system adjusted for Swedish ICD-10 version will be used to calculate a composite score to reflect comorbidity.

研究设计

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

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

  • All patients aged 18 years or older who were admitted to a Swedish hospital between 1st July 2014 and 31st December 2020 with an ICD-10 code for diverticular disease of the large intestine (K57.2- K57.9).
  • Emergency admissions.
  • Patients who underwent procedures relevant to diverticulitis.

排除标准

  • Patients who were diagnosed with colorectal cancer before the index date.
  • Patients with synchronous operations that are supposed to be irrelevant to acute diverticulitis.

结局指标

主要结局

Preferred operation for acute colonic diverticular disease

时间窗: Up to 78 months

Laparoscopic peritoneal lavage or sigmoid resection

次要结局

  • Crossover surgery(1 day)
  • Reoperation(From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months)
  • Postoperative length of hospital stay(From date of inclusion until the date of discharge, assessed up to 78 months)
  • Overall survival(From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months)
  • Thirty-day postoperative mortality(Up 30 days)
  • Colorectal cancer diagnosis(From date of inclusion until the date of the end of study or date of death from any cause, whichever came first, assessed up to 78 months)

研究者

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

Christos Kollatos

MD

Uppsala University Hospital

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