中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500109640
最近更新日期： Date of Last Refreshed on：	2025-09-23 14:57:26
注册时间： Date of Registration：	2025-09-23 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	沙培林局部应用预防黑色素瘤腹股沟淋巴结清扫术后淋巴漏的回顾性研究
Public title：	Local Application of Sapylin for Preventing Lymphatic Leakage after Inguinal Lymph Node Dissection in Melanoma: A Retrospective Cohort Study
注册题目简写：
English Acronym：
研究课题的正式科学名称：	沙培林局部应用预防黑色素瘤腹股沟淋巴结清扫术后淋巴漏的回顾性研究
Scientific title：	Local Application of Sapylin for Preventing Lymphatic Leakage after Inguinal Lymph Node Dissection in Melanoma: A Retrospective Cohort Study
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：	宁科镔	研究负责人：	吴振杰
Applicant：	Kebin Ning	Study leader：	Zhenjie Wu
申请注册联系人电话： Applicant telephone：	+86 187 7632 0582	研究负责人电话： Study leader's telephone：	+86 152 9654 1940
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：	ningkebin18@163.com	研究负责人电子邮件： Study leader's E-mail：	wuzhenjie523@126.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：	广西南宁市良庆区良玉大道50号	研究负责人通讯地址：	广西南宁市良庆区良玉大道50号
Applicant address：	No. 50 Liangyu Avenue, Liangqing District, Nanning City, Guangxi Province	Study leader's address：	No. 50 Liangyu Avenue, Liangqing District, Nanning City, Guangxi 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：	广西医科大学附属肿瘤医院
Applicant's institution：	Affiliated Tumor Hospital of Guangxi Medical University
研究负责人所在单位：	广西医科大学附属肿瘤医院
Affiliation of the Leader：	Affiliated Tumor Hospital of Guangxi 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：	KY2025986	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：	广西医科大学附属肿瘤医院科技伦理委员会
Name of the ethic committee：	Science and Technology Ethics Committee The Affiliated Tumor Hospital of Guangxi Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2025-08-21 00:00:00
伦理委员会联系人：	陈艺天
Contact Name of the ethic committee：	Yitian Chen
伦理委员会联系地址：	广西南宁市良庆区良玉大道50号
Contact Address of the ethic committee：	No. 50 Liangyu Avenue, Liangqing District, Nanning City, Guangxi Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 771 533 0855	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：

广西医科大学附属肿瘤医院

Primary sponsor：

Affiliated Tumor Hospital of Guangxi Medical University

研究实施负责（组长）单位地址：

广西南宁市良庆区良玉大道50号

Primary sponsor's address：

No. 50 Liangyu Avenue, Liangqing District, Nanning City, Guangxi 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)：	广西壮族自治区	市(区县)：	南宁市
Country：	China	Province：	Guangxi Zhuang Autonomous Region	City：	Nanning
单位(医院)：	广西医科大学附属肿瘤医院	具体地址：	广西南宁市良庆区良玉大道50号
Institution hospital：	Affiliated Tumor Hospital of Guangxi Medical University	Address：	No. 50 Liangyu Avenue, Liangqing District, Nanning City, Guangxi Province

经费或物资来源：

自行筹备资金

Source(s) of funding：

self-funded

研究疾病：

黑色素瘤

Target disease：

Melanoma

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：

回顾性研究

Study phase：

Retrospective study

研究设计：

队列研究

Study design：

Cohort study

研究目的：

主要目的：评估术中局部应用沙培林对术后淋巴漏发生率的降低效果次要目的：比较两组术后总引流量、引流管拔除时间、切口愈合时间、住院时间及并发症（感染、发热）

Objectives of Study：

Primary Objective: To evaluate the effect of intraoperative topical application of Sapylin on reducing the incidence of postoperative lymphatic leakage. Secondary Objectives: To compare total postoperative drainage volume, time to drain removal, wound healing time, length of hospital stay, and complications (infection, fever) between the two groups.

药物成份或治疗方案详述：

本研究中所有手术均由同一组经验丰富的外科医生进行。麻醉成功后，具体手术方式: 手术区域铺巾范围包括患侧大腿前侧全部及达脐部的下腹部。腿部置于轻度外旋位、膝关节屈曲。以股血管为中心作12-15cm纵行切口，上界达腹股沟皱襞（Malgaigne线），保留6-8mm皮下组织保护血供。解剖操作从内侧开始，明确长收肌、缝匠肌及大隐静脉腱膜，结扎大隐静脉；于长肌腱膜作内侧2～3cm 的切口，上下分别延伸至缝匠肌交点及腹股沟韧带，从内向外清扫淋巴结，至显露股静脉并完全暴露其内外侧；外侧沿缝匠肌腱膜全长切开，暴露股动脉前表面，沿股静脉向上找到大隐静脉弓，并将其结扎切断。之后继续沿股动静脉前表面解剖至腹股沟韧带，解剖股管并切除Cloquet淋巴结。游离缝匠肌并离断其腹股沟起点，转位覆盖腹股沟缺损处，近端与周围筋膜缝合，取周围筋膜及邻近皮瓣覆盖创面。严密止血、冲洗术野确认无活动出血后，研究组创面喷洒 20ml 沙培林注射液［由10支沙培林 (注射用A群链球菌)（山东国药集团鲁亚制药有限公司，国药准字S19980002，规格1ke/支）溶于20ml生理盐水中配制而成］，对照组喷洒等量生理盐水。沿股血管轴放置 10 号或 15 号多孔引流管；分层缝合切口（2-0可吸收线闭合皮下，3-0不可吸收线间断缝合皮肤），关闭切口后夹闭引流管 30 分钟再开放。嘱患者平卧休息，避免剧烈咳嗽，保持引流管通畅。当连续3天引流量均＜50ml时拔除引流管。

Description for medicine or protocol of treatment in detail：

All surgeries were performed by the same experienced surgical team. After anesthesia, the surgical field was draped to include the entire anterior thigh and lower abdomen to the umbilicus. The leg was placed in mild external rotation with knee flexion. A 12-15 cm longitudinal incision centered over the femoral vessels was made, extending superiorly to the inguinal crease (Malgaigne line), preserving 6-8 mm of subcutaneous tissue for vascularity. Dissection began medially, identifying the adductor longus, sartorius muscles, and saphenous vein fascia. The saphenous vein was ligated. An incision 2-3 cm medial to the adductor longus tendon was made, extending superiorly and inferiorly to the sartorius insertion and inguinal ligament. Lymph node dissection proceeded from medial to lateral, exposing the femoral vein completely. Laterally, the sartorius fascia was incised along its length, exposing the anterior surface of the femoral artery. The saphenofemoral junction was identified along the femoral vein, and the saphenous vein was ligated and divided. Dissection continued anteriorly along the femoral vessels to the inguinal ligament. The femoral canal was dissected, and Cloquet's node was removed. The sartorius muscle was mobilized, detached from its inguinal origin, transposed, and sutured over the femoral vessels to the inguinal ligament. The wound was covered using adjacent fascia and skin flaps. After meticulous hemostasis and irrigation, the Sapylin group received irrigation with 20ml of Sapylin solution [prepared by dissolving 10 vials of Sapylin (Shandong Guoyao Group Luya Pharmaceutical Co., Ltd., National Medicine Permit No. S19980002, 1 KE/vial) in 20ml normal saline]. The control group received irrigation with 20ml normal saline. A size 10 or 15 multi-hole drain was placed along the femoral vessels. The incision was closed in layers (subcutaneous tissue with 2-0 absorbable suture, skin with 3-0 non-absorbable interrupted sutures). The drain was clamped for 30 minutes post-closure before opening. Patients were advised bed rest, to avoid vigorous coughing, and to ensure drain patency. Drains were removed when output was <50ml for 3 consecutive days.

纳入标准：

Inclusion criteria

排除标准：

1.既往同侧腹股沟区手术或放疗史； 2.对青霉素或链球菌制剂过敏； 3.存在严重基础疾病（心功能III-IV级、肝肾功能衰竭等）； 4.病历资料不全

Exclusion criteria：

1. History of previous surgery or radiotherapy in the ipsilateral inguinal region; 2. Allergy to penicillin or streptococcal preparations; 3. Presence of severe underlying diseases (cardiac function class III-IV, hepatic or renal failure, etc.); 4. Incomplete medical records

研究实施时间：

Study execute time：

从 From 2022-01-01 00:00:00至 To 2025-03-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2022-01-01 00:00:00 至 To 2025-03-01 00:00:00

干预措施：

Interventions：

组别：	沙培林干预组	样本量：	51
Group：	Saplin intervention group	Sample size：	51
干预措施：	无	干预措施代码：
Intervention：	none	Intervention code：

组别：	盐水对照组	样本量：	54
Group：	Saline control group	Sample size：	54
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)：	广西壮族自治区	市(区县)：	南宁市
Country：	China	Province：	Guangxi Zhuang Autonomous Region	City：	Nanning
单位(医院)：	广西医科大学附属肿瘤医院	单位级别：	三甲
Institution hospital：	Affiliated Tumor Hospital of Guangxi Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	淋巴漏发生率	指标类型：	主要指标
Outcome：	postoperative lymphatic leakage incidence	Type：	Primary indicator
测量时间点：	术后第3天	测量方法：	淋巴清扫术后第3天起，连续2d及以上每日引流出100ml以上淡黄色伴有泡沫样液体
Measure time point of outcome：	The third postoperative day	Measure method：	Drainage of >100 ml/day of serous, frothy fluid for ≥2 consecutive days starting from postoperative day 3

指标中文名：	总引流量	指标类型：	次要指标
Outcome：	Total drainage volume	Type：	Secondary indicator
测量时间点：	术后第1天	测量方法：	统计引流瓶中引流液计量
Measure time point of outcome：	The first day after surgery	Measure method：	Record the volume of drainage fluid in the drainage bottle.

指标中文名：	引流管拔除时间	指标类型：	次要指标
Outcome：	time to drain removal	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	切口愈合时间	指标类型：	次要指标
Outcome：	wound healing time	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	住院时间	指标类型：	次要指标
Outcome：	length of hospital stay	Type：	Secondary 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：	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		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）：

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	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）：	待本研究结果正式发表后 6 个月内，启动原始数据的共享流程，不通过公共平台（如 ResMan）向公众开放原始数据的在线浏览或自由下载；如需获取原始数据，需向本研究负责人（联系人：宁科镔；邮箱：ningkebin18@163.com）提交书面申请，说明数据使用目的（仅限科研用途），经研究者审核通过并获得本研究伦理委员会（广西医科大学附属肿瘤医院伦理委员会，批件号：KY2025986）批准后，通过加密邮件或线下签署数据使用保密协议后的对接方式提供（数据已去标识化，不含参试者隐私信息）。（补充说明：本研究为回顾性队列研究，原始数据涉及参试者隐私保护，暂不采用公开共享模式；但严格遵循《中国临床试验注册中心关于推进共享临床试验原始数据的公告》要求，确保数据可通过合规申请路径共享，且共享过程符合伦理规范及数据安全要求)
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Within 6 months after the formal publication of the study results, the process for sharing raw data will be initiated. The raw data will not be made publicly available for online browsing or free download via public platforms (such as ResMan). To obtain the raw data, a written application must be submitted to the principal investigator of this study (Contact: Ning Kebin; Email: ningkebin18@163.com), specifying the purpose of data use (for research purposes only). Upon review and approval by the investigator, and after obtaining approval from the Ethics Committee of this study (Ethics Committee of the Affiliated Tumor Hospital of Guangxi Medical University, Approval No.: KY2025986), the data will be provided via encrypted email or through offline methods after signing a data use confidentiality agreement. The data will be de-identified and contain no private information of the participants. (Supplementary note: This study is a retrospective cohort study. As the raw data involve the protection of participants’ privacy, a public sharing model will not be adopted. However, it strictly complies with the "Announcement on Promoting the Sharing of Clinical Trial Raw Data" by the Chinese Clinical Trial Registry, ensuring that the data can be shared through compliant application channels, and that the sharing process adheres to ethical standards and data security requirements.)
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：	广西医科大学附属肿瘤医院电子病历系统
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Electronic Medical Record (EMR) System of Guangxi Medical University Tumor Hospital
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-09-23 14:57:08