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Axillary Web Syndrome After Breast Cancer Surgery: Incidence, Risk Factors, and Functional Outcomes

2026年8月19日 更新者:Mehmet Ölçüm、Antalya City Hospital

A Prospective Multicenter Cohort Study on the Incidence, Risk Factors, and Postoperative Functional Outcomes of Axillary Web Syndrome After Breast Cancer Surgery

Axillary web syndrome (AWS), sometimes called "cording," is a condition that can develop after breast cancer surgery in which the lymph nodes under the arm are removed or sampled. It appears as one or more tight, painful cord-like structures running from the armpit down the inner arm. It can limit shoulder movement, cause pain, and interfere with daily activities.

It is not yet clear how often AWS occurs, when it typically appears after surgery, which patients are most likely to develop it, or whether it is related to the arm swelling (lymphedema) that some patients experience after breast cancer treatment. Most previous studies looked back at patient records rather than following patients forward in time, so the answers remain uncertain.

In this study, women who are having breast cancer surgery with either sentinel lymph node biopsy or axillary lymph node dissection will be examined before their operation and then at set times afterward: 2, 4, and 8 weeks, and 3 and 6 months. At each visit, the study doctor will examine the armpit and arm for cords, measure how far the shoulder can move, ask the patient to rate any pain, and measure the circumference of both arms to check for swelling.

The study does not change the surgery or treatment a patient receives. It adds only these examinations and measurements, which are not painful and do not require blood tests or imaging. The researchers hope the results will help identify which patients are at higher risk, so that rehabilitation can be started earlier.

研究概览

详细说明

Background and Rationale

Axillary web syndrome is a postoperative complication characterized by palpable, often painful fibrotic cords extending from the axilla along the upper extremity, occurring after axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB) for breast cancer. It may lead to restricted shoulder range of motion, pain, functional loss, and reduced quality of life.

Reported incidence in the literature ranges from approximately 28% to 40%. However, the majority of published studies are retrospective in design, and prospective data obtained through regular, structured physical examination are limited. The risk factors for AWS and its relationship with breast cancer-related lymphedema (BCRL) remain insufficiently defined.

A prospective cohort study using systematic postoperative follow-up and standardized measurements is therefore expected to characterize the true incidence, timing, clinical course, and risk factors of AWS more reliably.

Design and Setting

This is a prospective, observational, multicenter cohort study conducted at two general surgery departments. The study population consists of consecutive patients undergoing surgery for breast cancer with axillary staging (SLNB or ALND) at either participating center. No separate control group is included; patients who develop AWS will be compared with those who do not within the same cohort.

To ensure data consistency across centers, all assessments are performed using a predefined standardized data collection form and identical measurement methods.

Assessments

Preoperative assessment: demographic data, body mass index, TNM stage, and comorbid conditions are recorded. Shoulder range of motion is measured with a goniometer and pain intensity is assessed using a Visual Analog Scale (VAS).

Operative data: type of surgery performed, number of lymph nodes removed, operative time, and early postoperative complications are recorded.

Postoperative follow-up: patients are assessed at fixed time points (weeks 2, 4, and 8; months 3 and 6). At each visit, the presence of AWS is investigated by inspection and palpation, with the number and anatomical location of cords recorded; shoulder range of motion is measured by goniometry; pain intensity is assessed by VAS; and development of BCRL is evaluated by bilateral arm circumference measurements.

Patients diagnosed with AWS receive conservative management according to routine institutional practice, and time to resolution is recorded.

Data Handling

Data from both centers are anonymized and pooled into a common database for analysis.

研究类型

观察性的

注册 (估计的)

250

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • BAGCILAR
      • Istanbul、BAGCILAR、土耳其(türkiye)、34100
        • 招聘中
        • Bagcilar Training and Research Hospital
        • 接触:
    • Kepez
      • Antalya、Kepez、土耳其(türkiye)、07080
        • 招聘中
        • Antalya City Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Consecutive patients undergoing surgery for breast cancer with axillary staging by sentinel lymph node biopsy or axillary lymph node dissection at the general surgery departments of the two participating centers. Patients who develop axillary web syndrome and those who do not are compared within the same cohort; no separate control group is enrolled.

描述

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of breast cancer with planned surgical treatment
  • Axillary staging performed by sentinel lymph node biopsy or axillary lymph node dissection
  • Written informed consent provided

Exclusion Criteria:

  • Preoperative restriction of shoulder range of motion
  • History of neuromuscular disease affecting the upper extremity
  • Metastatic disease
  • Anticipated inability to comply with the follow-up protocol

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Patients undergoing axillary surgery for breast cancer
Consecutive patients aged 18 years and older undergoing surgery for breast cancer with axillary staging by sentinel lymph node biopsy or axillary lymph node dissection at either participating center. All participants are assessed preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively for the presence of axillary web syndrome, shoulder range of motion, pain intensity, and arm circumference. No study-specific alteration is made to surgical or oncological management.
Axillary staging performed as part of routine breast cancer surgical management, either as sentinel lymph node biopsy or axillary lymph node dissection. The choice of procedure is made according to standard clinical indications and is not determined by the study protocol.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Incidence of axillary web syndrome
大体时间:From surgery through 6 months postoperatively
Proportion of participants in whom axillary web syndrome is identified at any postoperative assessment. Diagnosis is made clinically by inspection and palpation of a visible or palpable cord extending from the axilla along the upper extremity
From surgery through 6 months postoperatively
Time to onset of axillary web syndrome
大体时间:From surgery through 6 months postoperatively
The postoperative assessment visit at which axillary web syndrome is first detected, among participants who develop it. Assessments occur at weeks 2, 4, and 8 and at months 3 and 6
From surgery through 6 months postoperatively

次要结果测量

结果测量
措施说明
大体时间
Risk factors associated with development of axillary web syndrome
大体时间:From surgery through 6 months postoperatively
Association between development of axillary web syndrome and age, body mass index, type of axillary surgery (sentinel lymph node biopsy versus axillary lymph node dissection), number of lymph nodes removed, adjuvant therapy received, and comorbid conditions
From surgery through 6 months postoperatively
Shoulder range of motion
大体时间:Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
Shoulder range of motion of the operated side measured in degrees by goniometry, compared between participants who develop axillary web syndrome and those who do not
Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
Pain intensity measured by Visual Analog Scale
大体时间:Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
Pain intensity in the operated upper extremity rated on a Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain
Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
Incidence of breast cancer-related lymphedema and its association with axillary web syndrome
大体时间:From surgery through 6 months postoperatively
Development of lymphedema assessed by bilateral upper extremity circumference measurements, and its association with the presence of axillary web syndrome
From surgery through 6 months postoperatively
Time to resolution of axillary web syndrome with conservative management
大体时间:From detection through 6 months postoperatively
Time from detection of axillary web syndrome to clinical resolution of the cord in participants receiving conservative management
From detection through 6 months postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2026年8月19日

首先提交符合 QC 标准的

2026年8月19日

首次发布 (实际的)

2026年8月21日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared. The study protocol and informed consent do not include provisions for sharing individual-level data with parties outside the research team.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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