Axillary Web Syndrome After Breast Cancer Surgery: Incidence, Risk Factors, and Functional Outcomes
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Mehmet Olcum, MD
- 전화번호: +905388101828
- 이메일: mehmetolcum@hotmail.com
연구 연락처 백업
- 이름: Merve Tokocin, MD
- 전화번호: +905356235594
- 이메일: mervetokocin@gmail.com
연구 장소
-
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BAGCILAR
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Istanbul, BAGCILAR, 터키 (Türkiye), 34100
- 모병
- Bagcilar Training and Research Hospital
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연락하다:
- Merve Tokocin, MD
- 전화번호: +905356235594
- 이메일: mervetokocin@gmail.com
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-
Kepez
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Antalya, Kepez, 터키 (Türkiye), 07080
- 모병
- Antalya City Hospital
-
연락하다:
- Mehmet Olcum, MD
- 전화번호: +905388101828
- 이메일: mehmetolcum@hotmail.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of axillary web syndrome
기간: From surgery through 6 months postoperatively
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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
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From surgery through 6 months postoperatively
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Time to onset of axillary web syndrome
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Risk factors associated with development of axillary web syndrome
기간: From surgery through 6 months postoperatively
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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
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From surgery through 6 months postoperatively
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Shoulder range of motion
기간: Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
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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
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Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
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Pain intensity measured by Visual Analog Scale
기간: Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
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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
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Preoperatively and at weeks 2, 4, and 8 and months 3 and 6 postoperatively
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Incidence of breast cancer-related lymphedema and its association with axillary web syndrome
기간: From surgery through 6 months postoperatively
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Development of lymphedema assessed by bilateral upper extremity circumference measurements, and its association with the presence of axillary web syndrome
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From surgery through 6 months postoperatively
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Time to resolution of axillary web syndrome with conservative management
기간: From detection through 6 months postoperatively
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Time from detection of axillary web syndrome to clinical resolution of the cord in participants receiving conservative management
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From detection through 6 months postoperatively
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공동 작업자 및 조사자
협력자
협력자
간행물 및 유용한 링크
일반 간행물
- Dinas K, Kalder M, Zepiridis L, Mavromatidis G, Pratilas G. Axillary web syndrome: Incidence, pathogenesis, and management. Curr Probl Cancer. 2019 Dec;43(6):100470. doi: 10.1016/j.currproblcancer.2019.02.002. Epub 2019 Mar 15.
- Gonzalez-Rubino JB, Vinolo-Gil MJ, Martin-Valero R. Effectiveness of physical therapy in axillary web syndrome after breast cancer: a systematic review and meta-analysis. Support Care Cancer. 2023 Apr 12;31(5):257. doi: 10.1007/s00520-023-07666-x.
- Brunelle CL, Serig A. Is axillary web syndrome a risk factor for breast cancer-related lymphedema of the upper extremity? A systematic review and meta-analysis. Breast Cancer Res Treat. 2024 Dec;208(3):471-490. doi: 10.1007/s10549-024-07518-0. Epub 2024 Oct 16.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 215/2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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