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临床试验/NCT05620446
NCT05620446已完成不适用

Endoscopic Management of Acute Sigmoid Volvulus in High Risk Surgical Eldery Patients: A Randomized Controlled Trial.

Zagazig University2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年12月10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
18
试验地点
2
主要终点
efficacy and safety of endoscopic management of acute sigmoid volvulus

研究概览

简要总结

This prospective randomized controlled clinical trial included all patients who developed the manifestations of acute a cute sigmoid volvulus and referred to the Zagazig University Hospital Emergency Department between December 2020 and August 2022. The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 9989/23-10-2022), Patients with age of ≥60 years-old , with acute sigmoid volvulus not managed by rectal deflating tube, with no evidence of bowel ischemia, with ASA III & IV , high risk surgical patients , with comorbidities and on sepsis but not septic shock were included and eligible for randomization. We excluded patients who were with good general condition (ASAI&II), patients with age below 60 years , patients with bowel ischemia and patients managed by rectal deflating tube.

Included eligible patients were simply randomized at a 1:1 ratio to "Endoscopic (SG)" or "Surgical Colostomy Group (EG)" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention.

详细描述

Introduction:

Sigmoid volvulus is a surgical emergency and if untreated, it will lead to bowel ischemia & perforation with high incidence of mortality (1). Most of the patients with sigmoid volvulus are old age with many co-morbidities (2). So, the risk of surgery for those elderly patients is high and is associated with high incidence of morbidity & mortality (3) . Early intervention is required for managing the sigmoid volvulus to avoid its serious complications , so the less invasive intervention is the best for those high risk elderly patients (4) . Usually in the past after failure of deflating rectal tube to untwist the volvulus , the patients were subjected for surgical colostomy to relive the intestinal obstruction with high risk consent for elderly patients then in later session , they were subjected for definitive surgery (5) . As the emergency surgery is associated with high incidence of morbidity & mortality in elderly patients, so the endoscopic approach becomes the first line of management to resolve the obstruction in uncomplicated sigmoid volvulus in elderly patients (6). The endoscopic untwist of the acute sigmoid volvulus was first described by Bruusgaard and had the advantage of both diagnostic & therapeutic values (7) . For diagnostic value, the endoscopy evaluate the mucosa and its viability , it is also important to exclude other causes of intestinal obstruction , the length of the endoscopy is enough to reach beyond site of twist and diagnose the torsion as the site of twist appears spiral , sphincter area of the mucosa (8). For therapeutic value , it is successful in treating the acute volvulus by incidence of 75%-95% , but with high recurrence rate up to 90% (9). The elective definitive surgery few days later after the endoscopy was postponed in elderly patients for many reasons , so in our study we will try to fix the sigmoid colon also by endoscopy without needs for general anesthesia and major surgery.

Objectives:

To evaluate the advantages and safety of Endoscopic management of acute sigmoid volvulus in high risk surgical patients and its effect in reducing morbidity and postoperative hospital stay.

Patients and Methods Patients This prospective randomized controlled clinical trial included all patients who developed the manifestations of acute a cute sigmoid volvulus and referred to the Zagazig University Hospital Emergency Department between December 2020 and August 2022. The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 9989/23-10-2022), and was retrospectively submitted in clinicaltrials.gov in November 2022 (NCT05051683). The study was performed in accordance with the code of ethics of the World Medical Association (Declaration of Helsinki) for studies involving human subjects. Written informed consent was obtained from all participants after explaining to them all the study procedures with its benefits and hazards. Patients with age of ≥60 years-old , with acute sigmoid volvulus not managed by rectal deflating tube, with no evidence of bowel ischemia, with ASA III & IV , high risk surgical patients , with comorbidities and on sepsis but not septic shock were included and eligible for randomization. We excluded patients who were with good general condition (ASAI&II), patients with age below 60 years , patients with bowel ischemia and patients managed by rectal deflating tube.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

盲法说明

no masking

入排标准

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

入选标准

  • Patients with age of ≥60 years-old ,
  • patients with acute sigmoid volvulus not managed by rectal deflating tube,
  • patients with no evidence of bowel ischemia,
  • patients with ASA III & IV , high risk surgical patients ,
  • patientswith comorbidities
  • patients on sepsis but not septic shock

排除标准

  • patients with good general condition (ASAI&II),
  • patients with age below 60 years ,
  • patients with bowel ischemia
  • patients managed by rectal deflating tube

结局指标

主要结局

efficacy and safety of endoscopic management of acute sigmoid volvulus

时间窗: within one week after intervention

incidence of postoperative complication

次要结局

  • efficacy of endoscopic management of acute sigmoid volvulus(within 6 month post operative)

研究者

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

Said Mohamed Said Abdou Negm

lecturer of general surgery

Zagazig University

研究点 (2)

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