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临床试验/NCT06077318
NCT06077318尚未招募不适用

Comparison of the Sugarbaker and Keyhole Repair for Parastomal Hernia: 10 Years of Experience From a Single Center in China

Fudan University0 个研究点目标入组 100 人开始时间: 2023年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
recurrence rate

研究概览

简要总结

Parastomal hernia (PSH) is difficult to manage, with high rates of post-operative recurrence and complication. Keyhole and Sugarbaker are the most commonly used techniques in the surgical repair of the PSH. However, the efficacy and safety of the two surgical methods have not been adequately compared in the East Asian population.

Patients diagnosed with PSH who underwent Sugarbaker or Keyhole repair from August 2012 to August 2022 will be included. Patient demographic data and postoperative outcomes will be retrospectively analyzed. The primary outcome measure is the recurrence rate at one year follow-up time.

详细描述

Consecutive patients undergoing surgical PSH repair in the Hernia Center of Huadong Hospital Affiliated to Fudan University from August 2012 to August 2022 were included in this study. Huadong Hospital undertakes surgical treatment of complex hernia and abdominal wall diseases in Shanghai, China. The surgical records and clinical data of patients will be retrospectively analyzed. Due to the retrospective design of the study, the patient's informed consent was waived. The study was conducted following the ethical standards set out in the 1964 Declaration of Helsinki and its later amendments.

The patient's surgical strategy was made by the center's experienced colorectal surgeons or specialists in the department of hernia and abdominal wall surgery. In surgical practice, preference is given to the laparoscopic approach, while open surgery is chosen in cases of severe abdominal adhesions. The following three aspects of clinical data were recorded: (1) patients' demographic data, such as age, sex, the primary disease for the stoma, body mass index and comorbidities; (2) Surgical details: repair technique, size of abdominal wall defect, duration of the surgical procedure; (3) Short-term and long-term postoperative outcomes: the primary outcome is the recurrence rate at one year follow-up time, while the secondary outcomes were length and cost of the hospitalization, and rates of the intensive care unit admission, chronic pain, surgical site infection (SSI), re-admission and re-operation rates within 30 days after surgery, major complications after surgery, and surgery-related death.

Only PSH patients who received intraperitoneal onlay Sugarbaker and Keyhole mesh were included. These patients were scheduled for follow-up appointments at the outpatient clinics, specifically at 1 month, 3 months, and 1 year after surgery. If recurrence is suspected by the surgeon after a physical examination, the patient would be requested for an abdominal CT scan. During the CT scan, patients were asked to perform the Valsava maneuver to facilitate the identification of any potential recurrences through imaging. Postoperative major complications were defined as complications requiring hospitalization after surgery to the one-year follow-up time. Patients with follow-up periods of less than one year were excluded from the cohort. Recorded death, recurrence, or loss to follow-up were considered to be the endpoint.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Only PSH patients who received intraperitoneal onlay Sugarbaker and Keyhole mesh were included.

排除标准

  • Patients with less than one year follow-up periods were excluded from the cohort.
  • Patients received other repair approaches.

结局指标

主要结局

recurrence rate

时间窗: one year follow-up time

recurrence was determined by CT scan

次要结局

  • chronic pain(one year follow-up time)
  • surgical site infection(30 days after surgery)
  • major complication(one year follow-up time)
  • reoperation and readmission(30 days after surgery)

研究者

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

Zhijun Bao

Director

Fudan University

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