ChiCTR2500099423 版本V1.0 版本创建时间2025/03/24 11:44:33 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500099423 

最近更新日期：

Date of Last Refreshed on：

 2025-03-24 11:44:28 

注册时间：

Date of Registration：

 2025-03-24 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

可调节体位垫对于胃癌患者术后腰痛水平的干预效果研究

Public title：

Study on the Intervention Effect of Adjustable Positioning Cushion on Postoperative Lumbago Level in Patients Undergoing Minimally Invasive Radical Surgery for Gastric Cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

可调节体位垫对于胃癌患者术后腰痛水平的干预效果研究

Scientific title：

Study on the Intervention Effect of Adjustable Positioning Cushion on Postoperative Lumbago Level in Patients Undergoing Minimally Invasive Radical Surgery for Gastric Cancer

研究课题代号(代码)：

Study subject ID：

 107

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

358251

申请注册联系人：

郑丽娜 

研究负责人：

郑丽娜 

Applicant：

Lina Zheng 

Study leader：

Lina Zheng 

申请注册联系人电话：

Applicant telephone：

 +86 150 5915 2720

研究负责人电话：

Study leader's
telephone：

+86 150 5915 2720

申请注册联系人传真 ：

Applicant Fax：

 83357896

研究负责人传真：

Study leader's fax：

 83357896

申请注册联系人电子邮件：

Applicant E-mail：

 369898579@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 369898579@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

福建省福州市鼓楼区新权路29号

研究负责人通讯地址：

福建省福州市鼓楼区新权路29号

Applicant address：

29 Xinquan Road, Gulou District, Fuzhou City, Fujian Province

Study leader's address：

29 Xinquan Road, Gulou District, Fuzhou City, Fujian Province

申请注册联系人邮政编码：

Applicant postcode：

 350000

研究负责人邮政编码：

Study leader's postcode：

 350000

申请人所在单位：

福建医科大学附属协和医院

Applicant's institution：

Union Hospital affiliated to Fujian Medical University

研究负责人所在单位：

福建医科大学附属协和医院

Affiliation of the Leader：

Union Hospital affiliated to Fujian Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2024KY105

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

福建医科大学附属协和医院伦理委员会

Name of the ethic committee：

Ethics Committee of Union Hospital affiliated to Fujian Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-06-14 00:00:00

伦理委员会联系人：

赖晓钰

Contact Name of the ethic committee：

Xiaoyu Lai

伦理委员会联系地址：

福建省福州市鼓楼区新权路29号协和医院

Contact Address of the ethic committee：

Union Hospital, 29 Xinquan Road, Gulou District, Fuzhou City, Fujian Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 591 8335 7896

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

福建医科大学附属协和医院

Primary sponsor：

Union Hospital affiliated to Fujian Medical University

研究实施负责（组长）单位地址：

福建省福州市鼓楼区新权路29号

Primary sponsor's address：

29 Xinquan Road, Gulou District, Fuzhou City, Fujian Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

福建

市(区县)：

福州

Country：

China

Province：

Fujian

City：

Fuzhou

单位(医院)：

福建医科大学附属协和医院

具体地址：

福建省福州市鼓楼区新权路29号

Institution
hospital：

Union Hospital affiliated to Fujian Medical University

Address：

29 Xinquan Road, Gulou District, Fuzhou City, Fujian Province

经费或物资来源：

自费

Source(s) of funding：

Self-paying

研究疾病：

胃癌  

Target disease：

Gastric cancer

研究疾病代码：

C16

Target disease code：

C16

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

了解胃癌根治性切除术患者术后腰痛的发生状况及其影响因素；分析目前临床常用改良体位垫对预防患者术后不适的应用效果和影响效果的因素；评价可调节体位垫对缓解微创胃癌根治术患者腰痛、皮肤压力性损伤，降低局部镇痛药使用情况和提高患者术后早期生活质量等方面的应用效果。  

Objectives of Study：

Understand the incidence and influencing factors of postoperative lumbago in patients undergoing minimally invasive radical surgery for gastric cancer; analyze the application effectiveness of currently clinically used modified positioning cushions in preventing postoperative discomfort and the factors influencing their effectiveness; evaluate the application effectiveness of adjustable positioning cushions in alleviating lumbago and pressure injuries, reducing local analgesic use, and improving early postoperative quality of life in patients undergoing minimally invasive radical surgery for gastric cancer."

药物成份或治疗方案详述：

对照组：行胃癌根治性切除术的患者，对患者提供手术前心理支持、人文关怀、健康宣教、体位摆置配合指导，接受医护人员为患者提供常规水平分腿位摆置，摆放方法:全麻诱导完成后将病人摆放为近似“人”字位。选择分腿板手术床，病人平卧气管插管后头部垫头圈，抬高3-5cm，保持前屈位；右上肢置于身体侧，用布单固定，左上肢呈＜90°外展，安置于托手架上。腿板角度水平分开60-90 °，此时病人呈近似“人”字形，膝关节微屈外旋保持功能位，双下肢用绑带固定等常规照护。 试验组：在常规照护的基础上，实施麻醉前位于患者腰椎生理曲线处摆放可调节体位垫，待患者于手术床安置稳定后开始调节体位垫高度，手动充气，使体位垫气囊扩张，充气量以患者舒适为宜。术后第一天、第三天、第五天进行随访，观察患者腰痛水平。 

Description for medicine or protocol of treatment in detail：

Control Group: Patients who underwent radical gastrectomy for gastric cancer were provided with preoperative psychological support, humanistic care, health education, and guidance on body position placement. They received the routine split-leg position placement provided by medical staff for patients. The placement method was as follows: After the induction of general anesthesia was completed, the patient was placed in an approximate "herringbone" position. A split-leg operating table was selected. After the patient was placed in a supine position and intubated, a head ring was placed under the head, elevated by 3 - 5 cm, and maintained in a flexed position. The right upper limb was placed on the side of the body and fixed with a sheet. The left upper limb was abducted at an angle of less than 90° and placed on a hand support. The angle of the leg plates was horizontally separated by 60 - 90°, and at this time, the patient was in an approximate "herringbone" shape. The knee joints were slightly flexed and externally rotated to maintain the functional position, and both lower limbs were fixed with straps and other routine care was provided. Experimental Group: On the basis of routine care, an adjustable body position pad was placed at the physiological curve of the patient's lumbar spine before anesthesia. After the patient was stably placed on the operating table, the height of the body position pad was adjusted. It was manually inflated to expand the airbag of the body position pad, and the amount of inflation was adjusted to the comfort level of the patient. Follow-up was conducted on the first, third, and fifth days after the operation to observe the level of low back pain in the patients. 

纳入标准：

1.年龄>=18岁； 2.首诊胃癌，拟行腹腔镜或机器人辅助全胃根治性切除术或远端胃根治性切除术的患者； 3.未合并心脑肺等其他基础疾病； 4.取得知情同意的患者。

Inclusion criteria

1.Age>=18 years old; 2.Patients with initial diagnosis of gastric cancer, scheduled for laparoscopic or robot-assisted total gastrectomy or distal gastrectomy; 3.Absence of other underlying diseases such as cardiovascular, cerebrovascular, or pulmonary conditions; 4.Patients who have provided informed consent.

排除标准：

1.胃神经内分泌癌； 2.有认知障碍、精神疾病的患者； 3.手术过程中转为开放手术； 4.术后转ICU的患者。

Exclusion criteria：

1.Gastric neuroendocrine carcinoma 2.Patients with cognitive impairments or mental illnesses 3.Conversion to open surgery during the procedure 4.Patients transferred to ICU postoperatively

研究实施时间：

Study execute time：

从 From 2024-06-15 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-06-17 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 98

Group：

Experimental group

Sample size：

干预措施：

在常规照护的基础上，实施麻醉前位于患者腰椎生理曲线处摆放可调节体位垫，待患者于手术床安置稳定后开始调节体位垫高度，手动充气，使体位垫气囊扩张，充气量以患者舒适为宜。

干预措施代码：

 1

Intervention：

On the basis of routine care, an adjustable position pad was placed at the physiological curve of the patient's lumbar spine before anesthesia. After the patient was stabilized on the operating bed, the height of the position pad was adjusted, and the air bag of the position pad was manually inflated, so that the air filling rate was appropriate for the patient's comfort.

Intervention code：

组别：

对照组

样本量：

 98

Group：

Control group

Sample size：

干预措施：

行微创胃癌根治性切除术的患者，对患者提供手术前心理支持、人文关怀、健康宣教、体位摆置配合指导，接受医护人员为患者提供常规水平分腿位摆置，摆放方法:全麻诱导完成后将病人摆放为近似“人”字位。选择分腿板手术床，病人平卧气管插管后头部垫头圈，抬高3-5cm，保持前屈位；右上肢置于身体侧，用布单固定，左上肢呈＜90°外展，安置于托手架上。腿板角度水平分开60-90 °，此时病人呈近似“人”字形，膝关节微屈外旋保持功能位，双下肢用绑带固定等常规照护。

干预措施代码：

 0

Intervention：

For patients undergoing minimally invasive radical resection of gastric cancer, preoperative psychological support, humanistic care, health education, and body positioning coordination guidance were provided to the patients, and the medical staff provided the patients with conventional horizontal leg parting placement. Placement method: After the induction of general anesthesia, the patients were placed in approximately "human" character position. A split-leg plate operating bed was selected. After tracheal intubation, the patient's head was placed on the head ring, raised by 3-5cm, and kept in the forward flexion position. The right upper limb is placed on the side of the body and fixed with a cloth sheet. The left upper limb is < 90° abduction and placed on a handrest. The Angle of the leg plate is separated horizontally by 60-90 °. At this time, the patient is in a similar "human" shape. The knee joint is slightly flexion and external rotation to maintain the functional position.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

 福州 

Country：

China

Province：

Fujian

City：

Fuzhou

单位(医院)：

 福建医科大学附属协和医院 

单位级别：

 三级 

Institution
hospital：

Union Hospital affiliated to Fujian Medical University

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

腰痛

指标类型：

主要指标

Outcome：

Low back pain

Type：

Primary indicator

测量时间点：

术后第一天、术后第三天、术后第五天

测量方法：

使用NRS评分量表

Measure time point of outcome：

The first day after the operation, the third day after the operation, and the fifth day after the operation.

Measure method：

Use the Numerical Rating Scale (NRS)

指标中文名：

皮肤压力性损伤

指标类型：

次要指标

Outcome：

Pressure-induced Skin Injury

Type：

Secondary indicator

测量时间点：

手术结束后至患者推送至麻醉复苏室前

测量方法：

采用吴欣娟、霍孝蓉主审版《压力性损伤临床防治》（国际指南 2019）

Measure time point of outcome：

After the operation is completed and before the patient is transferred to the post-anesthesia care unit (PACU).

Measure method：

Adopt the "Clinical Prevention and Treatment of Pressure Injuries" (International Guidelines 2019) with Wu Xinjuan and Huo Xiaorong as the chief reviewers.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机数表法

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random number table method

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

由于手术过程放置体位垫，较难对干预者和研究对象实施盲法，故仅对资料调查员和统计分析员设盲。

Blinding：

Due to the placement of body position pads during the surgical process, it is rather difficult to implement blinding on the interveners and the study subjects. Therefore, only the data investigators and the statistical analysts are blinded.

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

邮箱联系共享，联系邮箱：369898579@qq.com，在试验结束6个月内上传试验数据。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The test data will be uploaded within 6 months after the end of the experiment by email: 369898579@qq.com.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

福建医科大学附属协和医院胃外科病例系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data acquisition and management: doctor friend management system

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-03-24 11:44:28