跳至主要内容
临床试验/NCT05532384
NCT05532384Unknown不适用

Effect of Early Postoperative Drinking Water on Postoperative Recovery Quality of Patients With Thyroid Surgery

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
94
试验地点
1
主要终点
QoR-15 score on the first day after surgery

研究概览

简要总结

This study is a single-center, prospective and randomized controlled study to investigate the effects of early recovery of oral intake (E) and late recovery of oral intake (L) on postoperative recovery quality and satisfaction of patients undergoing thyroid surgery. The study's primary outcome is quality of recovery-15 scale (Qor-15).

详细描述

The subjects of this study are patients who will receive thyroid surgery in Peking Union Medical College Hospital. After the patient is included in the experiment, when the patient meets the exit criteria of the PACU, the patient will be randomly assigned to early resumption of oral intake group and late resumption of oral intake group to receive different treatments. Finally, researchers will collecte and evaluate the different outcome indicators of the two groups of patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The anesthesiologists will obtain the group of patients through computer randomization before the patients leave the Post-Anesthesia Care Unit, and guide the patients to drink water. The questionnaire collectors and outcomes assessor will not be informed of the group of patients.

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

  • ASA Physical Status I-II
  • Body mass index 18.5-29.9kg/m2
  • First operation on operation day
  • Thyroid surgery

排除标准

  • Patients or family members cannot understand the conditions and objectives of this study
  • Preoperative patients with acute pharyngitis, hoarseness, cough, dysphagia, and high risk of aspiration
  • The surgeons or anesthesiologists point out that the patient is not suitable for early postoperative drinking (such as considering the injury of recurrent laryngeal nerve or lymphatic vessels during the operation)
  • Exclusion criteria of QoR-15* (*QoR-15 exclusion criteria:
  • Unable to understand words and language;
  • Difficult to cooperate due to mental disorders;
  • History of alcohol or drug abuse;
  • Any serious pre-existing medical condition that can limit the objective evaluation after surgery;
  • Any life-threatening complications;
  • Emergency surgery)

结局指标

主要结局

QoR-15 score on the first day after surgery

时间窗: one day

Using QoR-15 questionnaire to evaluate the quality of perioperative recovery. QoR-15 consists of 15 comprehensive questions, including physical comfort (5 items), psychological support (2 items), physical independence (2 items), emotional state (4 items), and pain (2 items), each item is scored with 0-10 points, 0 represents poor state, 10 represents good state, and the total score is the QoR-15 score of the patient.

次要结局

  • Postoperative pain(through patient discharge, an average of 3-4 day)
  • QoR-15 score on the day of discharge(one day)
  • Patient satisfaction(through patient discharge, an average of 3-4 day)
  • Length of hospital stay(through patient discharge, an average of 3-4 day)
  • Recovery of digestive function(through recovery of digestive function, an average of 1-2 day after surgery)
  • Total drainage volume after operation(through removal of drainage tube, an average of 2 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验