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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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

250

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • トルコ（Türkiye）
    • BAGCILAR
      • Istanbul、BAGCILAR、トルコ（Türkiye）、34100
        • 募集
        • Bagcilar Training and Research Hospital
        • コンタクト：
    • Kepez
      • Antalya、Kepez、トルコ（Türkiye）、07080
        • 募集
        • Antalya City Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
手順：Axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection)
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of axillary web syndrome
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Risk factors associated with development of axillary web syndrome
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Antalya City Hospital

協力者

İstanbul Bağcılar Training and Research Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月1日

一次修了 (推定)

2027年10月1日

研究の完了 (推定)

2027年10月1日

試験登録日

最初に提出

2026年8月19日

QC基準を満たした最初の提出物

2026年8月19日

最初の投稿 (実際)

2026年8月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月21日

QC基準を満たした最後の更新が送信されました

2026年8月19日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 215/2026

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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