ChiCTR2600126671 版本V1.0 版本创建时间2026/06/13 11:07:43 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：

 ChiCTR2600126671 

最近更新日期：

Date of Last Refreshed on：

 2026-06-13 11:07:30 

注册时间：

Date of Registration：

 2026-06-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

手术治疗慢传输型便秘：保留不同长度直肠的效果对比

Public title：

Surgical treatment of slow transit constipation: A comparative analysis of outcomes with different rectal preservation lengths

注册题目简写：

English Acronym：

研究课题的正式科学名称：

慢传输型便秘腹腔镜结肠次全切除盲肠直肠顺蠕动吻合术直肠保留长度的疗效分析

Scientific title：

Efficacy Analysis of Rectal Remnant Length in Laparoscopic Subtotal Colectomy with Isoperistaltic Cecorectal Anastomosis for Slow-Transit Constipation

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：

程康文 

研究负责人：

程康文 

Applicant：

Cheng Kangwen 

Study leader：

Cheng Kangwen 

申请注册联系人电话：

Applicant telephone：

 +86 13867408470

研究负责人电话：

Study leader's
telephone：

+86 571 6784700

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：

 chengkangwen0556@sina.com

研究负责人电子邮件：

Study leader's E-mail：

 chengkangwen0556@sian.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：

中国浙江省杭州市上城区浣纱路261号

研究负责人通讯地址：

中国浙江省杭州市上城区浣纱路261号

Applicant address：

261 Huansha Road, Shangcheng District, Hangzhou, Zhejiang, China

Study leader's address：

261 Huansha Road, Shangcheng District, Hangzhou, Zhejiang, China

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：

杭州市第一人民医院

Applicant's institution：

Hangzhou First People's Hospital

研究负责人所在单位：

杭州市第一人民医院

Affiliation of the Leader：

Affiliated hangzhou first people's hospital, zhejiang university school of medicine

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：

 2026ZN266-1

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：

杭州市第一人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Hangzhou First People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-05-25 00:00:00

伦理委员会联系人：

陆蕴

Contact Name of the ethic committee：

Lu Yun

伦理委员会联系地址：

中国浙江省杭州市上城区浣纱路261号

Contact Address of the ethic committee：

261 Huansha Road, Shangcheng District, Hangzhou, Zhejiang, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 571 56007507

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 1742208034@qq.com

研究实施负责（组长）单位：

杭州市第一人民医院

Primary sponsor：

Affiliated hangzhou first people's hospital, zhejiang university school of medicine

研究实施负责（组长）单位地址：

中国浙江省杭州市上城区浣纱路261号

Primary sponsor's address：

261 Huansha Road, Shangcheng District, Hangzhou, Zhejiang, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江

市(区县)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

杭州市第一人民医院

具体地址：

中国浙江省杭州市上城区浣纱路261号

Institution
hospital：

Affiliated hangzhou first people's hospital, zhejiang university school of medicine

Address：

261 Huansha Road, Shangcheng District, Hangzhou, Zhejiang, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

研究疾病：

慢传输型便秘  

Target disease：

Slow transit constipation

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

探究直肠保留长度对腹腔镜结肠次全切除术盲肠直肠顺蠕动吻合术治疗慢传输型便秘术后疗效的影响  

Objectives of Study：

To explore the effect of rectal retention length on postoperative efficacy of laparoscopic subtotal colectomy with cecorectal isoperistaltic anastomosis in the treatment of slow transit constipation

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.符合功能性便秘罗马Ⅳ（Rome IV）诊断标准；
2.年龄处于18～75周岁范围内；
3.便秘状况严重，显著降低患者生活及工作质量；
4.结肠传输试验结果：72h结肠内仍有多枚标志物残留，全结肠传输时间明显延长，符合慢传输行便秘表现；
5.长期保守治疗无效；
6.排除肠道器质性疾病；
7.肛门直肠测压：未见盆底肌功能及反射异常。排粪造影：无直肠前突、直肠黏膜脱垂、肠疝、无耻骨直肠肌痉挛、矛盾收缩、肛直角排便时正常开大，排除出口梗阻性便秘；
8.排除先天性巨结肠及其他神经肌肉疾病；
9.患者具有明确的手术意愿并签署知情同意；
10.所有患者能够耐受手术治疗及术后随访且无明显精神心理障碍或严重系统性疾病；

Inclusion criteria

1.Fulfilled the diagnostic criteria for functional constipation according to the Rome IV criteria;
2.Aged between 18 and 75 years;
3.Experienced severe constipation symptoms that significantly impaired quality of life and work performance;
4.Demonstrated delayed colonic transit on the colonic transit study, with multiple radiopaque markers retained in the colon at 72 hours and a markedly prolonged total colonic transit time, consistent with slow-transit constipation (STC);
5.Failed to achieve satisfactory symptom relief despite long-term conservative treatment, including dietary modification, laxatives, and prokinetic therapy;
6.Had no evidence of organic colorectal disease;
7.Underwent anorectal physiological evaluation showing no abnormalities of pelvic floor muscle function or anorectal reflexes on anorectal manometry. Defecography excluded outlet obstruction-related disorders, including rectocele, rectal mucosal prolapse, enterocele, puborectalis syndrome, paradoxical pelvic floor contraction, and impaired opening of the anorectal angle during defecation;
8.Had no evidence of congenital megacolon or other neuromuscular disorders affecting intestinal motility;
9.Expressed a clear willingness to undergo surgery and provided written informed consent;
10.Were considered suitable candidates for surgery and postoperative follow-up, with no significant psychiatric disorders or severe systemic diseases that could affect treatment outcomes;

排除标准：

1.严重系统性疾病：严重冠心病、失代偿期心功能不全、严重糖尿病并发症、严重呼吸系统疾病或脑血管疾病等，无法耐受本次手术者;
2.排粪造影异常（直肠前突、会阴下降、耻骨直肠肌肥厚、压迹加深）、肛门直肠测压异常（排便时肛门外括约肌/耻骨直肠肌矛盾收缩、排便推动力不足、括约肌紧张）符合出口梗阻型便秘诊断;
3.存在结肠结构性/解剖异常（先天性巨结肠、结肠狭窄、结肠憩室病、憩室炎等）结肠肿瘤性病变（结直肠癌、结肠良性肿瘤、结肠腺瘤、息肉）炎症性肠病等结直肠器质性疾病者；
4.严重精神心理疾病（如重度抑郁症、精神分裂症等）或存在明显精神障碍，无法配合治疗及随访者；
5.存在胃肠道其他动力障碍，如小肠动力障碍、胃排空障碍等全消化道动力异常者；
6.既往接受过结直肠重大手术或腹部手术导致解剖结构明显改变者；
7.随访资料不完整或术后失访者；

Exclusion criteria：

1.Presence of severe systemic diseases that precluded surgical treatment, including severe coronary artery disease, decompensated heart failure, severe diabetic complications, advanced respiratory disease, cerebrovascular disease, or other conditions associated with an unacceptable operative risk;
2.Evidence of obstructed defecation syndrome (ODS) based on anorectal physiological and imaging assessments, including abnormal findings on defecography (e.g., rectocele, excessive perineal descent, hypertrophy of the puborectalis muscle, or deep puborectalis impression) and/or anorectal manometry demonstrating paradoxical contraction of the external anal sphincter or puborectalis muscle during defecation, inadequate propulsive force, or increased sphincter tone;
3.Presence of structural or organic colorectal diseases, including congenital megacolon, colonic stricture, colonic diverticular disease, diverticulitis, colorectal malignancy, benign colonic tumors, adenomas, polyps, inflammatory bowel disease, or other organic colorectal disorders;
4.Severe psychiatric or psychological disorders, such as major depressive disorder or schizophrenia, or any mental condition that could interfere with treatment compliance or postoperative follow-up;
5.Presence of other gastrointestinal motility disorders, including small-bowel dysmotility, delayed gastric emptying, or generalized gastrointestinal motility dysfunction involving multiple segments of the digestive tract;
6.History of major colorectal surgery or abdominal surgery resulting in significant anatomical alterations that could affect surgical planning or postoperative outcomes;
7.Incomplete follow-up data or loss to follow-up after surgery.

研究实施时间：

Study execute time：

从 From 2026-06-15 00:00:00至 To 2028-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-15 00:00:00 至 To 2027-12-01 00:00:00

干预措施：

Interventions：

组别：

短残端组

样本量：

 30

Group：

Short Stump Group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

长残端组

样本量：

 30

Group：

Long Stump Group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

  

Country：

China

Province：

Zhejiang

City：

单位(医院)：

 杭州市第一人民医院 

单位级别：

 三级甲等 

Institution
hospital：

Affiliated hangzhou first people's hospital, zhejiang university school of medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Wexner 便秘评分

指标类型：

主要指标

Outcome：

Wexner Constipation Scale

Type：

Primary indicator

测量时间点：

术前/术后3、6、12月

测量方法：

住院、电话/微信随访以及门诊复查等方式进行，对患者术前及术后指标进行问卷调查。

Measure time point of outcome：

Preoperative / 3、6、12 months postoperatively

Measure method：

Patients were followed up through inpatient evaluations, telephone/WeChat interviews, and outpatient clinic visits. Standardized questionnaires were administered to assess and compare preoperative and postoperative clinical parameters.

指标中文名：

胃肠生活质量指数（GIQLI）评分

指标类型：

次要指标

Outcome：

Gastrointestinal Quality of Life Index (GIQLI) score

Type：

Secondary indicator

测量时间点：

术前/术后3、6、12月

测量方法：

住院、电话/微信随访以及门诊复查等方式进行，对患者术前及术后指标进行问卷调查。

Measure time point of outcome：

Preoperative/3、6、12 months postoperatively

Measure method：

Patients were followed up through inpatient evaluations, telephone/WeChat interviews, and outpatient clinic visits. Standardized questionnaires were administered to assess and compare preoperative and postoperative clinical parameters.

指标中文名：

腹痛 / 腹胀频率评分

指标类型：

次要指标

Outcome：

Abdominal pain/bloating frequency scale

Type：

Secondary indicator

测量时间点：

术前/术后3、6、12月

测量方法：

住院、电话/微信随访以及门诊复查等方式进行，对患者术前及术后指标进行问卷调查。

Measure time point of outcome：

Preoperative/3、6、12 months postoperatively

Measure method：

Patients were followed up through inpatient evaluations, telephone/WeChat interviews, and outpatient clinic visits. Standardized questionnaires were administered to assess and compare preoperative and postoperative clinical parameters.

指标中文名：

Wexner 失禁评分

指标类型：

主要指标

Outcome：

Wexner Incontinence Score (WIS)

Type：

Primary indicator

测量时间点：

术前/术后3、6、12月

测量方法：

住院、电话/微信随访以及门诊复查等方式进行，对患者术前及术后指标进行问卷调查。

Measure time point of outcome：

Preoperative/ 3、6、12 months postoperatively

Measure method：

Patients were followed up through inpatient evaluations, telephone/WeChat interviews, and outpatient clinic visits. Standardized questionnaires were administered to assess and compare preoperative and postoperative clinical parameters.

指标中文名：

直肠肛门测压（RAIR、肛管静息压 / 最大收缩压）

指标类型：

次要指标

Outcome：

Anorectal manometry (RAIR, anal resting pressure, maximum squeeze pressure)

Type：

Secondary indicator

测量时间点：

术前/术后3、6、12月

测量方法：

门诊复查及电话随访的方式进行，对患者术前及术后指标进行问卷调查。

Measure time point of outcome：

Preoperative/3、6、12 months postoperatively

Measure method：

Patients were followed up via outpatient clinic visits and telephone interviews, and questionnaires were administered to collect preoperative and postoperative parameters.

指标中文名：

直肠残端长度

指标类型：

次要指标

Outcome：

Rectal stump length

Type：

Secondary indicator

测量时间点：

术中

测量方法：

采用软尺分别测量肠管吻合处至腹膜反折最低点的实际距离

Measure time point of outcome：

Intraoperative

Measure method：

A soft ruler was used to measure the actual distance from the intestinal anastomosis site to the lowest point of the peritoneal reflection.

指标中文名：

手术时间

指标类型：

次要指标

Outcome：

Operative time

Type：

Secondary indicator

测量时间点：

术中

测量方法：

查阅住院病历及手术记录单收集

Measure time point of outcome：

Intraoperative

Measure method：

Relevant data were retrieved from inpatient medical records and operative documents.

指标中文名：

首次排气时间

指标类型：

次要指标

Outcome：

Time to first flatus

Type：

Secondary indicator

测量时间点：

术中

测量方法：

查阅住院病历及手术记录单收集

Measure time point of outcome：

Intraoperative

Measure method：

Relevant data were retrieved from inpatient medical records and operative documents.

指标中文名：

术后并发症

指标类型：

次要指标

Outcome：

Postoperative complications

Type：

Secondary indicator

测量时间点：

术后

测量方法：

查阅住院病历、术后病程记录及出院小结

Measure time point of outcome：

Postoperative

Measure method：

Review inpatient medical records, postoperative progress notes and discharge summaries

指标中文名：

住院时间

指标类型：

次要指标

Outcome：

Hospital stay

Type：

Secondary indicator

测量时间点：

术中

测量方法：

查阅住院病历及手术记录单收集

Measure time point of outcome：

Intraoperative

Measure method：

Relevant data were retrieved from inpatient medical records and operative documents.

指标中文名：

术中出血量

指标类型：

次要指标

Outcome：

Intraoperative blood loss

Type：

Secondary indicator

测量时间点：

术中

测量方法：

查阅住院病历及手术记录单收集

Measure time point of outcome：

Intraoperative

Measure method：

Relevant data were retrieved from inpatient medical records and operative documents.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

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：

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）：

无

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

None

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：

无

Blinding：

None

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）：

本研究为前瞻性临床研究，暂不对外公开原始临床数据，无公开数据发布时间及网络共享平台。

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

Individual participant data (IPD) will not be shared publicly. No relevant web-based database and access URL are available.

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：

本研究为前瞻性观察性研究，根据术中直肠实际保留长度自然分组，按统一纳入排除标准纳入研究对象。分别于入院时、术中及术后各固定时间节点系统采集临床资料。统一设计标准化病例观察记录表，由经过统一培训的专职研究人员完成数据采集与信息录入，规避信息偏倚。采集内容包括：受试者一般基线资料（性别、年龄、身体质量指数、NRS 2002 评分、糖尿病及心脑血管疾病等合并症、ASA 分级）；围手术期指标（直肠保留长度、手术时间、术中出血量、术后首次排气时间、术后住院时间、术后并发症），于术前及术后 3、6、12 个月通过住院记录、电话 / 微信随访及门诊复查，统一评估 Wexner 便秘评分、GIQLI 胃肠生活质量评分、腹痛腹胀评分、Wexner 肛门失禁评分，并完善肛门直肠测压检测。所有观察指标均参照统一临床标准评定，评估时间点全程固定一致，保证两组数据采集流程同质化、标准化。

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

This was a prospective observational study in which patients were naturally allocated into groups according to the actual length of the retained rectal stump measured intraoperatively. All participants were enrolled based on predefined inclusion and exclusion criteria. Clinical data were systematically collected at admission, during surgery, and at predetermined postoperative follow-up time points.A standardized case report form (CRF) was developed for the study, and all data collection and entry were performed by dedicated research personnel who had received uniform training, thereby minimizing information bias. The collected data included baseline demographic and clinical characteristics, such as sex, age, body mass index (BMI), Nutritional Risk Screening 2002 (NRS-2002) score, comorbidities (including diabetes mellitus and cardiovascular or cerebrovascular diseases), and the American Society of Anesthesiologists (ASA) physical status classification.Perioperative variables included rectal stump length, operative time, intraoperative blood loss, time to first postoperative flatus, postoperative length of hospital stay, and postoperative complications.Follow-up assessments were conducted preoperatively and at 3, 6, and 12 months after surgery through hospitalization records, telephone or WeChat interviews, and outpatient clinic visits. The Wexner Constipation Score, Gastrointestinal Quality of Life Index (GIQLI) score, abdominal pain and bloating scores, and Wexner Incontinence Score were uniformly evaluated at each follow-up time point. In addition, anorectal manometry was performed to assess anorectal function.All outcome measures were assessed according to standardized clinical criteria. The timing and procedures of data collection and evaluation were kept consistent throughout the study to ensure homogeneity and standardization between the two groups.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-13 11:07:30