ChiCTR2600121272 版本V1.0 版本创建时间2026/03/27 15:12:00 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：

 ChiCTR2600121272 

最近更新日期：

Date of Last Refreshed on：

 2026-03-27 15:11:42 

注册时间：

Date of Registration：

 2026-03-27 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

三维重建用于经阴道骶棘韧带固定术的精准化治疗研究

Public title：

A Precision Approach to Transvaginal Sacrospinous Ligament Fixation UtilizingThree-Dimensional Reconstruction

注册题目简写：

English Acronym：

研究课题的正式科学名称：

三维重建用于经阴道骶棘韧带固定术的精准化治疗研究

Scientific title：

A Precision Approach to Transvaginal Sacrospinous Ligament Fixation UtilizingThree-Dimensional Reconstruction

研究课题代号(代码)：

Study subject ID：

 2023-YBSF-654

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：

张超 

研究负责人：

张超 

Applicant：

Zhang Chao 

Study leader：

Zhang Chao 

申请注册联系人电话：

Applicant telephone：

 +86 133 8926 8216

研究负责人电话：

Study leader's
telephone：

+86 133 8926 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：

 zhangchao8216@163.com

研究负责人电子邮件：

Study leader's E-mail：

 zhangchao8216@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 西安市人民医院(西安市第四医院)

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：

新城区解放路21号

研究负责人通讯地址：

新城区解放路21号

Applicant address：

No. 21 Jiefang Road, Xincheng District, Xi‘an, Shaanxi, China

Study leader's address：

No. 21 Jiefang Road, Xincheng District, Xi‘an, Shaanxi, China

申请注册联系人邮政编码：

Applicant postcode：

 710000

研究负责人邮政编码：

Study leader's postcode：

 710000

申请人所在单位：

西安市人民医院(西安市第四医院)

Applicant's institution：

Xi'an People's Hospital (Xi'an Fourth Hospital)

研究负责人所在单位：

西安市人民医院(西安市第四医院)

Affiliation of the Leader：

Xi'an People's Hospital (Xi'an Fourth Hospital)

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：

 20220117

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：

西安市人民医院（西安市第四医院）医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Xi'an People's Hospital (Xi'an Fourth Hospital)

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-06-20 00:00:00

伦理委员会联系人：

史欣

Contact Name of the ethic committee：

Shi Xin

伦理委员会联系地址：

西安市新城区解放路21号

Contact Address of the ethic committee：

21 Jiefang Road, Xincheng District Xi'an City, Shaanxi Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 158 0922 7266

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 412892097@qq.com

研究实施负责（组长）单位：

西安市人民医院(西安市第四医院)

Primary sponsor：

Xi'an People's Hospital (Xi'an Fourth Hospital)

研究实施负责（组长）单位地址：

西安市新城区解放路21号

Primary sponsor's address：

21 Jiefang Road, Xincheng District Xi'an City, Shaanxi Province, 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)：

陕西

市(区县)：

西安

Country：

China

Province：

Shaanxi

City：

Xi'an

单位(医院)：

西安市人民医院(西安市第四医院)

具体地址：

西安市新城区解放路21号

Institution
hospital：

Xi'an People's Hospital (Xi'an Fourth Hospital)

Address：

21 Jiefang Road, Xincheng District Xi'an City, Shaanxi Province, China

经费或物资来源：

陕西省重点研发计划项目（项目编号：2023-YBSF-654）

Source(s) of funding：

Key Research and Development Project of Shaanxi Province (Project Number: 2023-YBSF-654)

研究疾病：

子宫脱垂  

Target disease：

Prolapse of Uterus

研究疾病代码：

N81

Target disease code：

N81

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1. 探讨基于MRA的三维重建技术在SSLF手术中的应用可行性，明确其对骶棘韧带及周围血管神经解剖结构的可视化效果。 2. 评估MRA三维重建辅助SSLF手术对手术精准性、安全性的影响，具体包括手术时间、术中出血量、术后并发症发生率等围术期指标。 3. 建立适合中国女性的SSLF手术个体化缝合点定位标准，为临床精准治疗提供参考依据。  

Objectives of Study：

1. Explore the feasibility of using MRA-based three-dimensional reconstruction technology in SSLF surgery, and clarify its visualization effect on the anatomical structure of the sacrospinous ligament and surrounding blood vessels and nerves. 2. Evaluate the impact of MRA three-dimensional reconstruction assisting SSLF surgery on the surgical accuracy and safety, including perioperative indicators such as operation time, intraoperative blood loss, and the incidence of postoperative complications. 3. Establish individualized suture point positioning standards for SSLF surgery suitable for Chinese women, providing a reference basis for clinical precise treatment.

药物成份或治疗方案详述：

选取2024年1月-2024年12月西安市人民医院（西安市第四医院）妇科就诊收治的60例子宫脱垂需行SSLF治疗的患者，采用随机数字表法分为研究组（30例）与对照组（30例）。研究组术前进行MRA扫描并运用Mimics 19.0软件行盆腔三维重建，明确骶棘韧带解剖参数及其与周围血管神经的解剖关系，采取个体化精准定位缝合点；对照组直接按照传统经验性手术方式定位骶棘韧带缝合点。比较两组患者的手术时间、术中出血量、术后住院时间、术后并发症发生率和术后1个月盆底功能障碍问卷（PFDI-20）评分，以及术后6个月内盆腔脏器脱垂复发情况。 

Description for medicine or protocol of treatment in detail：

A total of 60 patients with uterine prolapse who required SSLF treatment were enrolled from the Department of Gynecology, Xi'an People's Hospital (Xi'an No.4 Hospital) between January 2024 and December 2024. They were divided into the study group (n=30) and the control group (n=30) using a random number table method. The study group underwent preoperative MRA scanning and pelvic 3D reconstruction with Mimics 19.0 software to clarify the anatomical parameters of the sacrospinous ligament and its anatomical relationship with surrounding blood vessels and nerves, and individualized precise positioning of suture points was adopted. The control group directly located the suture points of the sacrospinous ligament using traditional empirical surgical methods. The operation time, intraoperative blood loss, postoperative hospital stay, incidence of postoperative complications, Pelvic Floor Distress Inventory-20 (PFDI-20) score at 1 month after surgery, and recurrence of pelvic organ prolapse within 6 months after surgery were compared between the two groups. Results The operation time of the study group was significantly shorter than that of the control group [(58.2±10.5) min vs. (75.6±12.3) min], the intraoperative blood loss was significantly less than that of the control group [(45.3±12.4) mL vs. (68.7±15.6) mL], and the postoperative hospital stay was significantly shortened [(3.4±0.7) d vs. (4.5±1.1) d], with statistical differences (P<0.05). The incidence of postoperative complications in the study group was 6.67% (2/30), including 1 case of mild lower limb numbness (relieved within 1 month after surgery) and 1 case of wound infection (healed after anti-infective treatment). The incidence of postoperative complications in the control group was 23.3% (7/30), including 3 cases of lower limb numbness and pain, 1 case of urinary dysfunction, 2 cases of wound infection, and 2 cases of intraoperative vascular injury (branches of the internal pudendal artery, intraoperative blood loss was 220 mL and 250 mL respectively, hemostasis was achieved by compression + hemostatic material packing). The difference in the incidence of complications between the two groups was statistically significant (P<0.05). At 1 month after surgery, the PFDI-20 score of the study group was significantly lower than that of the control group [(32.5±6.8) vs. (41.2±7.5)], with a statistical difference (P<0.05). One case of prolapse recurrence occurred in the control group within 6 months after surgery, and no recurrence occurred in the study group.  

纳入标准：

1.符合子宫脱垂诊断标准，POP-Q分期为Ⅲ~Ⅳ期； 2.自愿接受SSLF手术治疗且要求保留子宫； 3.无严重心、肝、肾等重要脏器功能障碍，可耐受手术及麻醉； 4.无盆腔手术史及盆腔放疗史； 5.可配合术前MRA检查、术后随访，自愿签署知情同意书。

Inclusion criteria

1.Meets the diagnostic criteria for uterine prolapse, with Pelvic Organ Prolapse Quantification (POP-Q) staging of stage III to IV; 2.Voluntarily agrees to receive sacrospinous ligament fixation (SSLF) surgery and requests uterine preservation; 3.No severe functional impairment of vital organs such as the heart, liver, and kidneys, and can tolerate surgery and anesthesia; 4.No history of pelvic surgery or pelvic radiotherapy; 5.Can cooperate with preoperative magnetic resonance angiography (MRA) examination and postoperative follow-up, and voluntarily signs the informed consent form.

排除标准：

1.合并宫颈癌变、子宫内膜病变等需同期切除子宫的疾病； 2.存在MRA检查禁忌症（金属植入物、幽闭恐惧症等）； 3.既往盆腔手术史或合并生殖系统畸形； 4.认知功能障碍，无法配合研究与随访； 5.因肥胖、肠道气体干扰导致MRA图像质量差，无法完成三维重建。

Exclusion criteria：

1.Complicated with diseases that require concurrent hysterectomy, such as cervical neoplasia and endometrial lesions; 2.Has contraindications for magnetic resonance angiography (MRA) examination (e.g., metal implants, claustrophobia); 3.Has a previous history of pelvic surgery or is complicated with genital tract malformations; 4.Has cognitive dysfunction and is unable to cooperate with the study and follow-up; 5.Poor quality of MRA images due to obesity or interference from intestinal gas, resulting in the inability to complete 3D reconstruction.

研究实施时间：

Study execute time：

从 From 2023-01-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-01-04 00:00:00 至 To 2024-12-31 00:00:00

干预措施：

Interventions：

组别：

研究组

样本量：

 30

Group：

Research Group

Sample size：

干预措施：

术前进行MRA扫描并运用Mimics 19.0软件行盆腔三维重建，明确骶棘韧带解剖参数及其与周围血管神经的解剖关系，采取个体化精准定位缝合点。

干预措施代码：

 B31

Intervention：

Preoperative MRA scanning was performed and Mimics 19.0 software was used for pelvic 3D reconstruction to clarify the anatomical parameters of the sacrospinal ligament and its anatomical relationship with surrounding blood vessels and nerves. Individualized precise positioning of suture points was adopted.

Intervention code：

组别：

对照组

样本量：

 30

Group：

Control Group

Sample size：

干预措施：

经阴道骶棘韧带固定术（传统经验性手术）

干预措施代码：

 B21

Intervention：

Transvaginal sacrospinous ligament fixation (traditional empirical surgery)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

 西安 

Country：

China

Province：

Shaanxi

City：

Xi'an

单位(医院)：

 西安市人民医院（西安市第四医院） 

单位级别：

 三甲 

Institution
hospital：

Xi'an People's Hospital (Xi'an Fourth Hospital)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后并发症

指标类型：

主要指标

Outcome：

Postoperative complications

Type：

Primary indicator

测量时间点：

围术期及术后 6 个月内

测量方法：

记录围术期及术后 6 个月内所有并发症，包括感染、出血、器官功能损伤等，按 临床诊断标准进行分类统计

Measure time point of outcome：

Perioperative period and within 6 months after surgery

Measure method：

Record all complications occurring during the perioperative period and within 6 months after surgery, including infection, bleeding, organ function injury, etc., and conduct classified statistics according to clinical diagnostic criteria

指标中文名：

手术时间

指标类型：

次要指标

Outcome：

Operation time

Type：

Secondary indicator

测量时间点：

术中（手术开始至结束期间）

测量方法：

使用秒表记录从皮肤切开至手术切口缝合完成的时间，单位为分钟

Measure time point of outcome：

Intraoperative (from skin incision to skin closure)

Measure method：

Record the time from skin incision to skin closure using a stopwatch, measured in minutes

指标中文名：

术中出血量

指标类型：

次要指标

Outcome：

Perioperative bleeding

Type：

Secondary indicator

测量时间点：

术中（手术结束时）

测量方法：

采用称重法或容积法，计量手术期间总出血量，单位为毫升（mL）

Measure time point of outcome：

Intraoperative (at the end of surgery)

Measure method：

Total intraoperative blood loss is measured by weighing or volumetric method, in milliliters (mL)

指标中文名：

术后住院时间

指标类型：

次要指标

Outcome：

Postoperative hospital stay

Type：

Secondary indicator

测量时间点：

出院时

测量方法：

计算从手术结束当日至出院当日的自然日天数，单位为天

Measure time point of outcome：

At discharge

Measure method：

Calculate the number of calendar days from the day of surgery completion to the day of discharge, measured in days

指标中文名：

术后盆底功能障碍评分（PFDI-20）

指标类型：

次要指标

Outcome：

Pelvic Floor Distress Inventory-20 (PFDI-20) score

Type：

Secondary indicator

测量时间点：

术后 1 个月

测量方法：

采用 PFDI-20 量表评估患者盆底功能障碍程度，分值越高表示功能障碍越严重，由经过培训的医护人员完成问卷填写

Measure time point of outcome：

1 month after surgery

Measure method：

The Pelvic Floor Distress Inventory-20 (PFDI-20) scale is used to evaluate the degree of pelvic floor dysfunction in patients. The higher the score, the more severe the dysfunction. The questionnaire is completed by trained medical staff.

指标中文名：

盆腔脏器脱垂复发率

指标类型：

次要指标

Outcome：

Recurrence rate of pelvic organ prolapse

Type：

Secondary indicator

测量时间点：

术后 6 个月

测量方法：

采用 POP-Q 分期评估，术后 6 个月 POP-Q 分期≥Ⅱ 期判定为脱垂复发，计算复发例数占组内总例数的比例

Measure time point of outcome：

6 months after surgery

Measure method：

Evaluated by POP-Q staging. Recurrence of pelvic organ prolapse is defined as POP-Q stage ≥Ⅱ at 6 months after surgery. Calculate the proportion of recurrent cases in the total number of cases in the group.

指标中文名：

三维模型测量结果

指标类型：

附加指标

Outcome：

Three-dimensional model measurement results

Type：

Additional indicator

测量时间点：

术前（影像学检查后、手术前）

测量方法：

基于术前 MRA 数据，使用三维重建软件构建模型，测量目标解剖参数（骶棘韧带宽度、厚度、距坐骨棘距离等）并记录数值

Measure time point of outcome：

Preoperatively (after imaging examination, before surgery)

Measure method：

Based on preoperative MRA data, construct 3D models using reconstruction software, measure target anatomical parameters (such as width, thickness of sacrospinous ligament, distance from ischial spine, etc.) and record the values.

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 45 岁 years
最大 Max age 75 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

由未参与患者招募与手术评估的统计人员，采用随机数字表法生成 1:1 分配的随机序列；序列由专人密封保管，术前开封用于分组。

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

The random sequence with 1:1 allocation was generated by a statistician who was not involved in patient recruitment and surgical assessment, using the random number table method. The sequence was sealed and kept by a dedicated person, and opened before surgery for group allocation.

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：

对结局评估者设盲，即负责评估手术时间、术中出血量、术后并发症等指标的研究人员不知晓受试者分组情况；受试者与术者因手术干预特性无法设盲。

Blinding：

Blinding was applied to outcome assessors: researchers responsible for evaluating outcomes (e.g., operation time, intraoperative blood loss, postoperative complications) were unaware of the subject’s group assignment. Due to the nature of surgical intervention, blinding of subjects and surgeons was not feasible.

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

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）：

本研究将在研究结束后 6 个月内，通过「ResMan 临床研究管理云平台」（https://www.medresman.org）共享经匿名化处理的原始数据及研究计划书。

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

The anonymized raw data and study protocol will be shared via the "ResMan Clinical Research Management Cloud Platform" (https://www.medresman.org) within 6 months after the completion of this study.

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：

本研究采用纸质病例记录表（CRF）进行初步数据采集，并通过 “ResMan 临床研究管理云平台”（https://www.medresman.org） 进行电子数据录入与管理。所有数据由两名研究人员独立录入并核对，确保数据准确性与完整性。

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

Data were initially collected using paper-based Case Report Forms (CRFs), then entered and managed electronically via the "ResMan Clinical Research Management Cloud Platform" (https://www.medresman.org). Two researchers independently entered and verified all data to ensure accuracy and completeness.

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：

  2026-03-27 15:11:42