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临床试验/NCT04387903
NCT04387903Unknown不适用

Surgical Intervention After Pancreaticoduodenectomy: Incidence, Indications, Risk Factors and Outcome

Mansoura University0 个研究点目标入组 1,000 人开始时间: 2000年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000
主要终点
Tumor recurrence

研究概览

简要总结

The aim of this study is to outline the incidence of early and late reoperation after PD, examine the risk factors for early surgical intervention and its impact on the surgical outcome, hospital stay, diseases recurrence and patient survival, address variable indications for late readmission and reoperation after PD and its impact on patient survival and disease recurrence.

详细描述

This is a retrospective cohort study of all patients who underwent PD for periampullary tumors in Gastrointestinal Surgical Center (GISC), Mansoura University, Egypt in the period between 2000 and 2018.The exclusion criteria included any patients with locally advanced periampullary tumor, metastases, patients with advanced liver cirrhosis (Child B or C), malnutrition, or coagulopathy.

Patient data were recorded in a prospectively maintained database. Preoperative variables included; age, sex, body mass index, patients' symptoms and signs, laboratory tests, tumor markers and preoperative biliary drainage. Intraoperative variables included; liver status, tumor size, pancreatic duct diameter, texture of the pancreas, operative time, blood loss, pancreatic reconstruction method and blood transfusion. Postoperative variables included postoperative complications, drain amylase, liver function, day to resume oral feeding, postoperative stay, re-exploration, hospital mortality, postoperative pathology, and surgical safety margins.

Data regarding reoperation included incidence, male to female ratio, hospital stay, interval to reoperation, number of explorations, indication of reoperation and surgical management, and postoperative outcome in terms of morbidity and hospital stay. Follow-up was carried out one week postoperatively, 3 months, 6 months and then after one year. The minimum duration of follow up was 2 years. Follow up was done by thorough history taking, clinical examination and abdominal CT in case of suspicious lesions on pelvi-abdominal ultrasound.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients who underwent pancreaticoduodenectomy for periampullary malignant lesions in the duration between January 2000 and May 2018

排除标准

  • Pancreaticoduodenectomy performed for benign tumors, recurrent malignant tumors, chronic pancreatitis, or inflammatory strictures were excluded from the study.

结局指标

主要结局

Tumor recurrence

时间窗: 2-20 years

Duration between surgery and recurrence of periampullary tumors based on radiological or endoscopic investigations.

Patient survival

时间窗: 2-20 years after surgery

The duration between surgical intervention to patient death

次要结局

  • Hospital stay after reoperation(10-90 days after reoperation)
  • Morbidity after reoperation(10-90 days after reoperation)
  • Risk factors for surgical reoperation(Before surgical intervention)

研究者

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

Hosam Hamed

Lecturer of general surgery

Mansoura University

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