ChiCTR2400088359 版本V1.0 版本创建时间2024/08/16 09:33:59 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：

 ChiCTR2400088359 

最近更新日期：

Date of Last Refreshed on：

 2024-08-16 09:32:26 

注册时间：

Date of Registration：

 2024-08-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

高级外科专科护士主导的多学科预康复管理模式在胃肠肿瘤手术患者中的应用研究

Public title：

Research on the application of multidisciplinary pre-rehabilitation management model led by senior surgical nurses in patients undergoing gastrointestinal tumor surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

高级外科专科护士主导的多学科预康复管理模式在胃肠肿瘤手术患者中的应用研究

Scientific title：

Research on the application of multidisciplinary pre-rehabilitation management model led by senior surgical nurses in patients undergoing gastrointestinal tumor surgery

研究课题代号(代码)：

Study subject ID：

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：

申请注册联系人：

刘曼丽 

研究负责人：

刘曼丽 

Applicant：

Manli Liu 

Study leader：

Manli Liu 

申请注册联系人电话：

Applicant telephone：

 +86 135 6030 8216

研究负责人电话：

Study leader's
telephone：

+86 135 6030 8216

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 liumanli201004@163.com

研究负责人电子邮件：

Study leader's E-mail：

 liumanli201004@163.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：

广东省广州市天河区黄埔大道西601号

研究负责人通讯地址：

广东省广州市天河区黄埔大道西601号

Applicant address：

No. 601, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong Province

Study leader's address：

No. 601, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong Province

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

暨南大学附属第一医院

Applicant's institution：

The First Affiliated Hospital of Jinan University

研究负责人所在单位：

暨南大学附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital of Jinan 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：

 KY-2023-365

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：

暨南大学附属第一医院涉人的科学研究伦理审查委员会

Name of the ethic committee：

The Ethics Review Committee of the First Affiliated Hospital of Jinan University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-12-28 00:00:00

伦理委员会联系人：

黄瑶

Contact Name of the ethic committee：

Yao Huang

伦理委员会联系地址：

广东省广州市天河区黄埔大道西601号

Contact Address of the ethic committee：

No. 601, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 302 0868 8217

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 liumanli201004@163.com

研究实施负责（组长）单位：

暨南大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of Jinan University

研究实施负责（组长）单位地址：

广东省广州市天河区黄埔大道西601号

Primary sponsor's address：

No. 601, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong 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)：

广州市

市(区县)：

广州市

Country：

China

Province：

Guangzhou City

City：

单位(医院)：

暨南大学附属第一医院

具体地址：

广东省广州市天河区黄埔大道西601号

Institution
hospital：

The First Affiliated Hospital of Jinan University

Address：

No. 601, Huangpu Avenue West, Tianhe District, Guangzhou City, Guangdong Province

经费或物资来源：

暨南大学护理学院

Source(s) of funding：

School of Nursing, Jinan University

研究疾病：

胃肠肿瘤  

Target disease：

Gastrointestinal tumors

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究拟探索以高级外科专科护士为主导、多学科协作的预康复管理模式，通过组建多学科预康复管理小组，综合考虑患者病情制定出科学、规范、个性化预康复策略，并将该策略用于胃肠肿瘤围手术期患者，以增强术前机体储备，减少术后并发症发生率，加快术后康复，改善临床结局，以期建立一套符合胃肠肿瘤患者预康复需求的标准化流程，也为临床医护人员探索一种新模式提供借鉴。  

Objectives of Study：

This study intends to explore a pre-rehabilitation management model led by senior surgical nurses and multidisciplinary collaboration. In order to enhance the preoperative body reserve, reduce the incidence of postoperative complications, accelerate postoperative rehabilitation, and improve clinical outcomes, the strategy should be used to enhance the preoperative body reserve, reduce the incidence of postoperative complications, accelerate postoperative rehabilitation, and improve clinical outcomes, in order to establish a standardized process that meets the pre-rehabilitation needs of patients with gastrointestinal tumors, and also provide reference for clinical medical staff to explore a new model.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

①符合胃肠肿瘤诊断标准，且经病理检查确诊； ②年龄18～75岁，性别不限； ③拟在我院行择期胃肠肿瘤切除手术治疗，手术日与住院日间隔＞5天； ④首次治疗，术前未接受过放疗、化疗等抗肿瘤治疗； ⑤知晓且愿意参加本研究者。

Inclusion criteria

(1) Meet the diagnostic criteria for gastrointestinal tumors and be diagnosed by pathological examination; (2) Age 18~75 years old, gender is not limited; (3) Elective gastrointestinal tumor resection surgery is planned to be performed in our hospital, and the interval between the operation day and the hospitalization day is > 5 days; (4) For the first treatment, no anti-tumor therapy such as radiotherapy and chemotherapy has been received before surgery; (5) Those who know and are willing to participate in this study.

排除标准：

①美国医师协会麻醉分级(American Society of Anesthesiologists , ASA)≥3级[66]； ②有不能耐受预康复训练的合并症; ③存在肢体障碍等无法行运动锻炼； ④合并严重的肝肾功能不全、痛风或不能耐受乳清蛋白粉； ⑤有认知障碍等无法合作者者。

Exclusion criteria：

(1) American Society of Anesthesiologists (ASA) classification ≥ 3 [66]; (2) Comorbidities that cannot tolerate pre-rehabilitation training; (3) Unable to exercise due to physical impairment; (4) Combined with severe liver and kidney insufficiency, gout or intolerance of whey protein powder; (5) Those who are unable to cooperate with those who have cognitive impairment or are unable to cooperate.

研究实施时间：

Study execute time：

从 From 2024-08-30 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-08-30 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 40

Group：

Intervention group

Sample size：

干预措施：

对照组在常规组护理基础上，于术前开展为期5～7天的预康复训练。实施专科护士主导的多学科合作术前预康复护理模式，具体步骤和内容如下。 （1）构建高级外科专科护士主导的多专科学组合作的预康复管理团队 建立预康复管理组织架构，成立预康复治疗小组和预康复护理管理小组。组建由3名高级外科专科护士为主导，以胃肠专科医生3名、康复师1名、营养师1名、心理治疗师1名的多学科核心团队，共同实施预康复管理。其中高级外科专科护士是本研究的统筹者 和主导者，主要负责设计本研究方案、全程协调团队工作、确定职责分工等；胃肠专科医生、营养师、康复师及心理治疗师主要负责制定个性化的预康复方案，高级外科专科护士综合评估以上方案并确定实施。实施过程中，胃肠专科医生主要负责营养处方的制定和专业知识的指导；心理咨询师主要负责个性化的心理指导；高级外科专科护士进行阶段性评价，参与制定出院后随访计划，发现问题，及时与团队沟通协调，共同商讨出最优方案。 （2）预康复管理小组流程的实施 1）患者评估 患者入院后由高级外科专科护士及胃肠专科医生共同协调，并发放由高级外科专科护士指定的《术前三联预康复策略指导手册》。胃肠专科医生开具评估医嘱后，高级外科专科护士、康复师、营养师及心理治疗师共同对患者一般情况做出评估，主要包括心理情况、生活质量、营养状态、心肺功能及运动能力等。 2）制定术前预康复方案 以高级外科专科护士为主导，康复师、营养师、心理治疗师及胃肠专科医生根据评估结果进行多学科合作，根据患者评估结果及个人意愿制定个体化需求的预康复方案。高级外科专科护士负责制定及实施预康复的宣传教育方案，同时发放《术前三联预康复策略完成日志》。 3）实施术前预康复方案 高级外科专科护士根据相关学科人员制定的预康复方案，组织多学科进行综合干预，综合干预主要包括营养、运动及心理方案的落实。（1）运动干预，具体包含有氧运动、无氧运动和呼吸功能锻炼；运动方案遵循循序渐进、强度逐渐增强的原则进行，当患者主观感知到吃力为最大运动限度范围，同时告知患者当出现恶心、呕吐、疲劳或呼吸困难等则立即停止运动，运动干预的方式、时间、频率和强度等遵循康复治疗师建议，高级外科专科护士负责指导与监督。（2）营养干预，术前5～7天采用营养风险筛查2002（nutritional risk screening 2002,NRS2002），对于无营养风险者，住院期间实施监测，及时发现营养问题，给予营养支持；对于NRS2002≥3分者，结合营养检验指标、人体学测量、膳食营养调查，计算患者每日所需热卡后，高级外科专科护士根据多学科共同制定的个性化营养方案进行饮食指导与评价，鼓励患者记录饮食日志。（3）心理干预，采用医院焦虑抑郁量表(the Hospital Anxiety and Depression Scale,HADS)进行心理评估，由心理治疗师提供专业的指导和治疗，主要包括正念指导、放松训练，高级外科专科护士负责监督管理与全程健康教育方案的落实。 4）预康复阶段性评价 通过出院前相关检验结果、检查结果及评估量表对患者住院期间预康复方案进行效果评价。 5）出院后随访计划的制定 高级外科专科护士负责制定出院后随访计划，随访方式采用随访群，随访时间为出院后1周、2周，1个月，随访内容为饮食营养、运动、伤口愈合情况、生活质量、排便情况等，鼓励患者每日在随访群打卡以上随访内容，高级外科专科护士负责及时录入患者信息及资料。

干预措施代码：

Intervention：

On the basis of conventional group nursing, the control group underwent pre-rehabilitation training for 5~7 days before surgery. Implement the multidisciplinary cooperative preoperative pre-rehabilitation nursing model led by specialist nurses, and the specific steps and contents are as follows. (1) Establish a pre-rehabilitation management team led by senior surgical nurses and multi-specialty scientific groups Establish an organizational structure for pre-rehabilitation management, and set up a pre-rehabilitation treatment team and a pre-rehabilitation nursing management team. A multidisciplinary core team led by 3 senior surgical nurses, 3 gastroenterologists, 1 rehabilitator, 1 dietitian, and 1 psychotherapist was established to jointly implement pre-rehabilitation management. Among them, the senior surgical specialist nurse is the coordinator and leader of this study, mainly responsible for designing the research plan, coordinating the team work throughout the process, and determining the division of responsibilities, etc.; gastroenterologists, dietitians, rehabilitation therapists and psychotherapists are mainly responsible for formulating personalized pre-rehabilitation programs, and senior surgical specialist nurses comprehensively evaluate the above programs and determine their implementation. During the implementation process, gastroenterologists are mainly responsible for the formulation of nutritional prescriptions and professional knowledge guidance, psychological counselors are mainly responsible for personalized psychological guidance, and senior surgical nurses conduct periodic evaluations, participate in the formulation of post-discharge follow-up plans, find problems, communicate and coordinate with the team in a timely manner, and jointly discuss the best plan. (2) Implementation of the pre-rehabilitation management team process 1) Patient assessment After the patient is admitted to the hospital, the senior surgical specialist nurse and the gastroenterologist will jointly coordinate and distribute the "Preoperative Triple Prerehabilitation Strategy Guidance Manual" designated by the senior surgical specialist nurse. After the gastroenterologist prescribes an evaluation order, the senior surgical nurse, rehabilitation therapist, dietitian and psychotherapist jointly evaluate the patient's general condition, mainly including psychological condition, quality of life, nutritional status, cardiopulmonary function and exercise capacity. 2) Develop a preoperative pre-rehabilitation plan Led by senior surgical nurses, rehabilitation therapists, dietitians, psychotherapists and gastroenterologists work together in a multidisciplinary manner based on the assessment results, and formulate a pre-rehabilitation plan for individual needs according to the assessment results and personal wishes. The senior surgical nurse is responsible for formulating and implementing the publicity and education program for pre-rehabilitation, and at the same time distributing the "Preoperative Triple Pre-rehabilitation Strategy Completion Log". 3) Implement a preoperative pre-rehabilitation program According to the pre-rehabilitation program formulated by the personnel of relevant disciplines, the senior surgical specialist nurse organizes multidisciplinary comprehensive intervention, which mainly includes the implementation of nutrition, exercise and psychological programs. (1) Exercise intervention, including aerobic exercise, anaerobic exercise and respiratory function exercise; the exercise program follows the principle of gradual and gradual increase in intensity, when the patient subjectively perceives that the exertion is the maximum range of exercise, and at the same time informs the patient to stop exercising immediately when nausea, vomiting, fatigue or dyspnea, etc., and the method, time, frequency and intensity of exercise intervention follow the recommendations of the rehabilitation therapist, and the senior surgical nurse is responsible for guidance and supervision. (2) Nutritional intervention, nutritional risk screening 2002 (NRS2002) 5~7 days before surgery, for those without nutritional risk, monitoring is carried out during hospitalization, nutritional problems are found in time, and nutritional support is given; for those with NRS2002≥ 3 points, combined with nutritional test indicators, anthropological measurements, After the dietary nutrition survey and the calculation of the patient's daily calorie requirement, the senior surgical nurse conducts dietary guidance and evaluation according to the personalized nutrition plan jointly formulated by multiple disciplines, and encourages the patient to keep a dietary diary. (3) Psychological intervention: The Hospital Anxiety and Depression Scale (HADS) was used for psychological assessment, and professional guidance and treatment were provided by psychotherapists, mainly including mindfulness guidance and relaxation training, and senior surgical nurses were responsible for supervising and managing the implementation of the whole health education program. 4) Phased evaluation of pre-rehabilitation The effect of the pre-hospitalization program was evaluated through the relevant test results, examination results and evaluation scales before discharge. 5) Development of a follow-up plan after discharge The senior surgical specialist nurse is responsible for formulating the post-discharge follow-up plan, the follow-up method adopts the follow-up group, the follow-up time is 1 week, 2 weeks, and 1 month after discharge, and the follow-up content is diet and nutrition, exercise, wound healing, quality of life, bowel movements, etc., and the patient is encouraged to check in the follow-up group every day The above follow-up content is encouraged, and the senior surgical specialist nurse is responsible for entering the patient's information and materials in a timely manner.

Intervention code：

组别：

对照组

样本量：

 40

Group：

control group

Sample size：

干预措施：

做好常规术前健康宣教，告知术前注意事项及疾病相关知识；术前营养风险筛查与指导，指导戒酒，进食高蛋白、高维生素等饮食，如当病人NRS-2002≥3分时，遵医嘱给予病人口服营养补充剂；术前心理护理，加强与患者及家属沟通，了解其需求与疑惑，耐心解答并缓解焦虑情绪；术前功能锻炼，指导吸烟患者严格戒烟，指导患者有效咳嗽和呼吸，吹气球训练。以上常规指导均由未纳入预康复管理小组的病房责任护士实施，干预时间为入院第1天至术前1天，术中和术后则按医院胃肠肿瘤手术ERAS标准流程进行。

干预措施代码：

Intervention：

Carry out routine preoperative health education, inform preoperative precautions and disease-related knowledge; Preoperative nutritional risk screening and guidance, guidance on quitting alcohol and consuming high protein, high vitamin, and other diets. For example, when the patient's NRS-2002 score is ≥ 3, oral nutritional supplements should be given to the patient according to medical advice; Preoperative psychological care, strengthening communication with patients and their families, understanding their needs and doubts, patiently answering and relieving anxiety; Preoperative functional exercise, guiding smoking patients to strictly quit smoking, guiding patients to effectively cough and breathe, and balloon blowing training. The above routine guidance is implemented by ward responsible nurses who are not included in the pre rehabilitation management team. The intervention time is from the first day of admission to the first day before surgery. During and after surgery, the ERAS standard procedure for gastrointestinal tumor surgery in the hospital is followed.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广州市 

市(区县)：

 广州市 

Country：

China

Province：

Guangzhou City

City：

单位(医院)：

 暨南大学附属第一医院 

单位级别：

 三级，三甲 

Institution
hospital：

The First Affiliated Hospital of Jinan University

Level of the institution：

Tertiary, Tertiary A

测量指标：

Outcomes：

指标中文名：

运动能力：6分钟步行距离

指标类型：

主要指标

Outcome：

Exercise ability: 6 minutes walking distance

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后康复：首次下床活动时间、排气及排便，术后住院时间，总住院天数，术后管道留置时间、住院期间总费用

指标类型：

主要指标

Outcome：

Postoperative rehabilitation: first time of getting out of bed activity, exhaust and defecation, postoperative hospital stay, total length of hospital stay, postoperative tube retention time, and total hospitalization expenses

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后30天内并发症的发生率：肺部感染、切口感染、吻合口漏、肠梗阻等

指标类型：

次要指标

Outcome：

The incidence of complications within 30 days after surgery: pulmonary infection, incision infection, anastomotic leakage, intestinal obstruction

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

营养指标：白蛋白、血红蛋白、总蛋白、前蛋白

指标类型：

主要指标

Outcome：

Nutritional indicators: Albumin, Hemoglobin, Total Protein, Preprotein

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 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）：

采用随机数字表法抽取80个数字，编号1～80，按入院顺序对应入号，根据随机数奇偶进行分组，奇数组为干预组，偶数组为对照组，随机将样本分为各40例。

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

80 numbers were selected by random number table method, numbered 1~80, corresponding to the admission number according to the admission order, and grouped according to the random odd and even, the odd number group was the intervention group, and the even number group was the control group, and the samples were randomly divided into 40 cases each.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

NA

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

不共享

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

Dot shared

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：

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)

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

A standard data collection and management system include a CRF and an electronic data capture

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：

  2024-08-16 09:32:26