跳至主要内容
临床试验/NCT06250699
NCT06250699招募中不适用

A Single Center Randomized Controlled Study on the Promotion of Rapid Recovery Through Tubeless Laparoscopic Adrenalectomy

Zhe Meng1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
First time up and about

研究概览

简要总结

The goal of this clinical trial is to exploring the role of tubeless after adrenalectomy surgery. The main questions it aims to answer are:

  1. The safety of tubeless laparoscopic adrenalectomy;
  2. The role of tubeless therapy in rapid recovery after adrenalectomy surgery Participants will be randomly divided into two groups: the non drainage group and the drainage group after laparoscopic adrenal surgery, and their pain, first time out of bed, and intestinal recovery time will be observed.

详细描述

The design type of this study is a prospective single center randomized controlled study, with a plan to recruit 200 patients who underwent laparoscopic adrenalectomy for the study. The intervention measures mainly include whether to indwelling drainage tubes. Prior to the start of the trial, our center had performed laparoscopic adrenalectomy on 89 patients without any obvious retroperitoneal fluid accumulation, redness, swelling, or fever, and the recovery was smooth. Step 1 of the research: Select patients who meet the criteria for laparoscopic adrenalectomy Step 2: Sign informed consent form Step 3: Randomly draw lots and divide them into two groups: no tube group (experimental group of 100 cases) and indwelling drainage tube group (control group of 100 cases) Step 4: Perform surgical plan according to grouping results Step 5: Test blood routine and ERAS related indicators 1-3 days after surgery Step 6: Follow up adrenal ultrasound at 1 month and 6 months after surgery Step 7: Follow up and analyze data Random plan Use block randomization method, using software SAS9.4 TS1M7, random seed number 2023092311 Observation items and testing time points 1. Test hemoglobin and drainage volume on 1-3 days after surgery Pain score, first time out of bed, intestinal ventilation time, adrenal ultrasound, postoperative fever, wound infection, and other indicators; During the follow-up one month after surgery, the adrenal region color ultrasound should also be tested; 3. During the follow-up examination at 6 months after surgery, ultrasound of the adrenal region should also be detected; Efficacy evaluation criteria and effectiveness evaluation methods: Whether the indwelling drainage tube has a promoting effect on the patient's rapid recovery (such as pain score, first time out of bed, intestinal ventilation time, etc.). Safety evaluation methods mainly include the subject's blood routine and vital signs.

研究设计

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

入排标准

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

入选标准

  • According to the 2022 edition of the Chinese Guidelines for Diagnosis and Treatment of Urological Diseases, patients who meet the surgical indications
  • The patient has signed an informed consent form before joining the clinical trial, and the age at the time of signing the informed consent form is 18-70 years old.

排除标准

  • Patients with complications that seriously affect treatment or quality of life
  • The patient has any physical condition that the researcher believes will affect the clinical status
  • Patients who have placed vascular stents such as heart and cerebrovascular stents within the past year
  • Pregnant or lactating patients

结局指标

主要结局

First time up and about

时间窗: 1-3 days after surgery

First time up and about after laparoscopic adrenalectomy

Pain score

时间窗: 1-3 days after surgery

Pain rating scale after laparoscopic adrenalectomy by VAS(visual analog scale for pain ) scale. The score ranges from 1 to 10, and the degree of pain gradually increases.

Hematoma

时间窗: 1-3 days after surgery

Detection of obvious hematoma (Hematoma area\> 4cm x 4cm) in the surgical area through color ultrasound. The results are expressed as yes or no.

Recovery time of intestinal function

时间窗: 1-3 days after surgery

Recovery time of intestinal function after laparoscopic adrenalectomy

次要结局

  • fever(1-3 days after surgery)

研究者

发起方
Zhe Meng
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhe Meng

Deputy chief physician

Zhongnan Hospital

研究点 (1)

Loading locations...

相似试验