Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Pain

Seroma

Inflammation

Following mastectomy, skin is closed using subcutaneous sutures followed by intracutaneous running suture. Depending on the surgeons discretion a vacuum closed suction drain was placed beneath the skin flaps.

The implemented intervention is the quilting suture technique. The subcutaneous tissue is sutured to the pectoralis muscle placing multiple rows of running sutures. The suture starts at either end of the scar, running back and forth, creating rows of quilting stiches. The rows are placed transversely from the cranial to the caudal end of the wound with 2-3 cm between them, totalling some three to ﬁve rows for the cranial ﬂap. The caudal ﬂap is quilted with 2-3 rows in a caudal to cranial fashion. A subcutaneous suture followed by a intracutaneous running suture is used to close the skin. No wound drain is placed.

Following mastectomy and/or axillary lymph node dissection, the subcutaneous tissue is sutured to the pectoralis muscle placing multiple rows of running sutures. The suture starts at either end of the scar, running back and forth, creating rows of quilting stiches. The rows are placed transversely from the cranial to the caudal end of the wound with 2-3 cm between them, totalling some three to ﬁve rows for the cranial ﬂap. The caudal ﬂap is quilted with 2-3 rows in a caudal to cranial fashion. A subcutaneous suture followed by a intracutaneous running suture is used to close the skin.

Quilting

Conventional wound closure

Lotte van Zeelst, MS

Luc Strobbe, PhD

Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting technique, in which the skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. Main objective of this randomized stepped wedge study is to assess the impact of large scale implementation of the quilting technique in patients undergoing mastectomy and/or axillary lymph node dissection. This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. The hypothesis is that quilting is a simple and cost-effective technique to increase textbook outcome. Moreover, it is expected that patient comfort is enhanced by quilting.

Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting technique, in which skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. However, implementation is lagging due to unknown side effects, increase in operation time and cost effectiveness. Main objective of this study is to assess the impact of large scale implementation of the quilting suture technique in patients undergoing mastectomy and/or axillary lymph node dissection (ALND).

The QUILT study is a stepped wedge design study performed among nine teaching hospitals in the Netherlands. The study consists of nine steps, with each step one hospital will implement the quilting suture technique. Allocation of the order of implementation will be randomization-based. Primary outcome is 'textbook outcome', i.e.no wound complications, no re-admission, re-operation or unscheduled visit to the outpatient clinic and use of analgesics is not increased postoperative. A total of 113 patients is required based on a sample size calculation.

This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. The hypothesis is that quilting is a simple technique to increase textbook outcome, without increasing health care consumption. Moreover, the expectation is that patient comfort is enhanced by quilting.

The QUILT study is a stepped wedge cluster randomized study.

Surgical technique is not blinded for surgeon and/or patients. An independent panel of four surgeons will blindly assess cosmetics.

The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery

The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery: a Stepped Wedge Cluster Randomized Trial Study

The datasets used and/or analysed during the study are available from the first and senior author on reasonable request.

'Textbook outcome' (TO), a combination of outcome parameters reflecting an ideal surgical outcome. Measured 6 months post-operative, the patients postoperative course must comply with the following to meet the definition of TO:

* no wound complications
* no re-admissions in relation to primary surgery
* no re-operation in relation to primary surgery, re-excisions in case of involved margins allowed
* no unscheduled visit to the outpatient clinic (depending on the centre one or two postoperative visits are usually scheduled)
* postoperative use of analgesics (6 months) is not increased compared to pre-operative

Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).

All aspirated seroma. Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).

Including skin flap necrosis, wound necrosis, wound dehiscence. Severity of complicaties are scored using the Clavien Dindo Classification of Surgical complications (grade I-V).

Length of hospital stay in days: distinguishing between outpatient and inpatient treatment.

Number of unscheduled visits to the outpatient clinic

Readmission to the hospital related to primary surgery

Reoperation related to primary surgery other than re-excision.

Assessed using the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Higher scores mean a worse outcome.

Assessed using the visual analogue scale (VAS). Scale 1-10, higher scores mean a worse outcome.

Post-operative use of analgesics (paracetamol, NSAID's, opioids).

an independent panel of four surgeons will blindly assess cosmetics by classifying standardised digital photographs one a 4-point Likert scale with the following categories: poor, fair, good and excellent. Photos are taken in two positions: the first in neutral position with both arms hanging next to the body and the second with both arms raised in 180gr (or as far as possible) elevation.

Rijnstate Hospital

OLVG

Martini Hospital Groningen

Catharina Ziekenhuis Eindhoven

St Jansdal Hospital

Bravis Hospital

Diakonessenhuis, Utrecht

St. Antonius Hospital

Gelderse Vallei Hospital

Canisius-Wilhelmina Hospital

Executive investigator

Blood and Lymph Conditions

Behaviors and Mental Disorders

Fatigue

Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Quality of Life

Minal Jain, R.P.T.

This study will examine the frequency and severity of problems in women with breast cancer during the first year after initial medical treatment, including:

* Physical impairments, such as loss of strength or flexibility, increased weight and swelling
* Symptom distress, such as pain, fatigue and weakness.
* Functional limitations and disabilities, such as loss of independence in activities of daily living (e.g., grooming, bathing, dressing, driving a car), work and social and recreational activities.

It will identify factors associated with these problems and try to determine their relationship to them.

Patients 18 years of age and older with stage I, II, III or IV breast cancer may be eligible for this study. Participants will be drawn from patients referred to the National Naval Medical Center for diagnosis and treatment during 2000-20001.

Participants will be interviewed and their medical records reviewed for past medical history, history of the present illness and social and recreational history. They will be seen five times over a 1-year period (initial visit and at 3, 6, 9, and 12 months), for 30-minute visits, which will include the following:

* Interview about past medical history and present illness, social and recreational activities, functional independence at work and during activities of daily living.
* Complete health survey and upper limb disability questionnaire; physical activity questionnaire to be completed at 6 and 12 months after medical treatment begins. The questionnaires take about 30 to 40 minutes to complete.
* Upper body examination, including pain measurement using a 10-point scale, an upper limb lift test, and measures of upper limb volume and girth.

This retrospective (case-control) outcome study will investigate the frequency and severity of morbidities in a population of approximately 160 patients diagnosed with breast cancer before and after medical and surgical treatment. Subjects will be followed for one-year with quarterly examinations (baseline \[pre-medical treatment\] and at 1, 3 months, 6 months, 9 months and 12 months after treatment). In order for cancer survivors to understand the risk of impairment and functional limitations, and disability; and for health care providers to determine the risk of physical impairment, functional limitations, and loss of independence (morbidity) in patients with breast cancer; it is necessary to study these patients from the point of diagnosis (before surgery) to a reasonable period following the completion of the primary treatment program (1 year after medical treatment). Although pain, numbness, fatigue, lymphedema and diminished physical function are described as prevalent and debilitating conditions, remarkably few clinical studies are published describing the associated physical impairments, functional limitations or on methods for their control with measures prior to medical intervention and long-term follow-up. While several past reports have identified the impact of medical and surgical intervention on symptom distress and functional capacity of these patients, these studies do not provide sufficient evidence to identify the: 1) level of physical impairment that predicts morbidity in these patients, 2) individual factors that are specific predictors of morbidity in these patients, or 3) time period in which these morbidities occur. The majority of previous studies investigating morbidity of patients with breast cancer following medical and surgical intervention are cross-sectional, case series, retrospective analysis without a comparison/control group and without baseline measures prior to intervention. The proposed outcome study will include: 1) a retrospective review of specific medical record information such as staging conference information and the standard clinical quarterly examination during a one year period, and 2) administration of a follow-up outcome questionnaire, a physical activity questionnaire and a quality of life questionnaire at the 6 and 12 months time points. The outcome survey is an upper limb disability questionnaire developed as an outcome measure for this project. Data available in these measurement domains will allow the researchers to determine the: 1) frequency and severity of: a) symptom distress (fatigue, pain including chronic pain, aching, weakness, burning, tingling, numbness, anxiety, and depression) and pathological conditions (adhesive capsulitis, weakness and atrophy, neuropathy, scar/skin adhesions, lymphedema), b) physical impairments (diminished upper extremity and trunk range of motion/flexibility, strength, coordination and increased girth), and c) functional imitations and disabilities during the course of the medical treatment (loss of independence in or ability to perform routine activities of daily living i.e., grooming, bathing, dressing, driving an automobile, and in some cases, return to their regular work, recreational and social activities). 2) level of impairment at which these patients have lost independence in function and identity those patients at higher risk for the loss of independence in function (e.g., ADL's).

Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer

Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer: A Multi-Institutional Study Between the National Institutes of Health (NIH) Rehabilitation Medicine Department (RMD) and the Walter Reed National Military Medical Center (WRNMMC) Breast Care Center

National Institutes of Health Clinical Center (CC)

Carcinoma

Carcinoma in Situ

Breast Carcinoma In Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Katrine R. Hauerslev, MD

Breast cancer affects a large proportion of Danish women and late morbidity following breast cancer treatment including pain, reduced motility and force of the arm and shoulder, disturbed sensitivity, and lymph edema affects many patients. The risk for such late complications have previously been carefully described by us and others in patients operated by traditional methods, but the follow-up in most of these studies have been rather short , and long time follow-up results are not available. The impact of the new oncoplastic techniques that allows more women to have breast conserving surgery is not known yet. These operations are more extensive and therefore might be accompanied by more complications. The purpose of this study is to give answer to that question.The study includes three parts. First a questionnaire to patients who have breast conserving surgery performed in one of the three breast units in Central Region Denmark. It contains questions regarding arm morbidity, quality of life, comorbidity, and body image. The questionnaire should be filled in preoperatively and 18 months after surgery. The second part consists of an objective evaluation of shoulder and arm function and cosmesis before and after breast conserving surgery with and without oncoplastic techniques. This should be performed at baseline before surgery and 18 months later. The third part is a long time follow-up of patients after breast conserving surgery without oncoplastic techniques. This group of patients is recruited from three breast units in Central Region Denmark. It contains questions regarding arm morbidity, quality of life, comorbidity, and body image. The questionnaire should be filled in preoperatively and 18 months after surgery. The second part consists of an objective evaluation of shoulder and arm function and cosmesis before and after breast conserving surgery with and without oncoplastic techniques. This should be performed at baseline before surgery and 18 months later. The third part is a long time follow-up of patients after breast conserving surgery without oncoplastic techniques. This group of patients is recruited from the cohort in a previous study with 18 months follow-up following breast conserving surgery without oncoplastic technique.

Aims and perspectives:

During the last 20 years there has been increasing focus on the morbidity following breast cancer treatment. This has lead to new and less mutilating surgical techniques to replace the traditional operations: Breast conserving surgery (BCS) instead of mastectomy and sentinel lymph node dissection (SLND) instead of axillary lymph node dissection (ALND). Lately, oncoplastic techniques have been introduced. These techniques further increase the ability to preserve the breast in breast cancer and are expected to increase the cosmetic results compared with traditional techniques, but they are somewhat larger procedures and might therefore lead to increased morbidity after treatment. Hitherto this has not been evaluated in clinical research trials.

The aim of the present study is to examine if oncoplastic techniques in relation to breast cancer treatment have an independent influence on morbidity and quality of life compared to traditional BCS.

In addition, a group of breast cancer patients treated with BCS 10 years ago and who underwent a similar study back then, will be invited to a reevaluation of shoulder function and morbidity.

Background:

Previously, mastectomy was the most applied surgical procedure related to breast cancer. Until the beginning of 1990's it was, by DBCG (Danish Breast Cancer Cooperative Group), recommended as a standard treatment. During the transition towards a more gentle surgical procedure, the use of oncoplastic techniques has been incorporated1,2.

The definition of oncoplastic breast surgery is defined by DBCG as: "a breast conserving procedure, including techniques of plastic surgery, where traditional breast conserving surgery would have lead to a cosmetic unsatisfactory result, and mastectomy would have been the alternative. The requirement for classifying a procedure as oncoplastic is 'the transfer of tissue that requires further skin incision than the breast conserving surgery in its own'3.

The oncoplastic techniques in breast cancer surgery are divided into 3 groups: volume displacement, volume reduction and volume replacement3-5. The oncological results of oncoplastic breast surgery has been evaluated in other studies and found comparable to the oncological results of traditional BCS and mastectomy6.

Increasing evidence have shown that among breast cancer patients a substantial fraction suffer from late symptoms including impairment of shoulder function, pain, disturbance in sensibility, and lymph edema7-9. The sequels are attributable to treatment related factors, including the breast surgical procedure10, axillary dissection11, and radiation therapy12. Studies indicate that sentinel lymph node biopsy (SNLB) reduces shoulder morbidity as compared to ALND11,13, but shoulder impairment also occur after this procedure14.

Recently, the occurrence of late symptoms has been addressed in two Danish publications based on questionnaires7,8 with 2-3 years8 and more than 5 years7 observation, respectively. These studies showed that chronic pain 2-3 years after surgery is a problem in up to 47% of patients of whom 13% suffered from severe and 39% from moderate pain8. More than five years after treatment, chronic pain was recorded in 29% of patients7, and this was associated with poorer quality of life and a higher medicine consumption. Furthermore, a large part of long time survivors reported arm swelling (25%), phantom symptoms (19%), paresthesia (47%), and allodynia (15%)7.

The reported frequency of Lymph oedema following breast cancer treatment vary considerably, probably depending on different definitions and different methods for measurement. As stated earlier, many patients report a subjective feeling of swelling, though the proportion of affected patients seems lower in studies, where objective measures are applied. In a study on node negative patients comparing the results of sentinel node biopsy (SNB) with axillary dissection (ALND)11 up to 18 months after surgery, arm swelling was reported in 7% and 44%, respectively, emphasizing the advantage of the more limited procedure. Using the water displacement method the difference in arm volume between these groups was very modest, although statistically significant. At 18 months, the arm volume on the operated side was 10 ml less than on the non-affected arm in the SNB group, compared with an increase of 28 ml in the ALND group. The water displacement method has been simplified and validated since15,16.

Shoulder morbidity median three years after surgery including ALND was measured in a study on 132 patients (mastectomy 67%, BCT 33%)10. The shoulder function was assessed by the Constant Shoulder Score (CSS), combining subjective symptoms with objective measures of range of motion (ROM) and strengths. Thirty-five percent of the patients had reductions in ROM, in most cases it was flexion and abduction that were most affected. Among these patients CSS was reduced by 12% on the treated side compared with the non-treated shoulder. Patients with normal ROM had comparable CSS on the two sides. In comparison with BCS and radiotherapy, mastectomy combined with postoperative radiation, more often lead to reduced ROM (OR 8.5). In the study by Husted Madsen et al.11 on more recently operated node negative patients, ALND turned out to be significantly associated with a poorer outcome when the dependent variable was the absence or presence of subjective arm and shoulder complaints.

Most studies concerning morbidity, especially those with objective evaluation of patients, have a short follow-up period typically only a few years. No such studies with long-term follow-up up to 5-10 years are available.

A few studies have aimed at describing the effect of physiotherapy on shoulder-arm morbidity13,17, and they have confirmed a better outcome after physiotherapy including general advice and recommendations about how to use and protect the affected arm and instructions for exercises. In the randomized study by Lauridsen et al.13, team instructed physiotherapy consisting of 12 sessions of 60 minutes twice a week instituted between the 6th and 8th postoperative week was compared to the same treatment postponed until the 26th postoperative week. The team instructed physiotherapy commenced early immediately improved the shoulder function, but the same treatment could improve shoulder function significantly even when instituted as long as six months postoperatively.

In a recently published randomized study, Veiga et al.18 have found indications of a better quality of life and self-esteem in BCS including oncoplastic surgery than in patients undergoing traditional BCS. On the other hand, in a study including 101 patients it was found that breast symmetry after BCS had had no effect on quality of life19. In that study symmetry was evaluated by a breast analyzing tool (BAT), one of more available objective measures. Most often, symmetry has been evaluated subjectively by a panel of experts, which has been considered the gold standard. Lately, Cardoso et al. have introduced another objective method where the cosmetic outcome is evaluated semi-automatically from systematic clinical fotos20. They reported a 70% agreement between the expert panel and their measurements. The cosmetic outcome after BCS has been evaluated by Lyngholm et al.21 using the "breast retraction assessment" (BAT) which estimates the symmetry based on measurements on clinical photos22.

The relation between the oncoplastic surgical techniques and shoulder disability, chronic pain, and lymph edema has hitherto not been systematically investigated, but some attempts have been made to describe the impact on shoulder function of post-mastectomy reconstructive surgery. In a study from Sweden23, shoulder function after reconstructive procedures involving the latissimus dorsi flap was examined. The main finding was that the reconstruction lead to an insignificant increase in long-term shoulder morbidity, but it was also noted that a small subset of patients developed long-term impairment.

Design and methods:

The study includes three parts:

1. A questionnaire describing the occurrence of loco-regional morbidity in patients who has undergone breast conserving surgery with and without oncoplastic techniques.
2. Objective evaluation of shoulder and arm function and cosmesis before and after breast conserving surgery with and without oncoplastic techniques.
3. Long time follow-up of patients after breast conserving surgery without oncoplastic techniques.

Part 1

The questionnaire combines previous used and validated forms addressing shoulder and arm function, pain, sensibility, cosmesis and body image, and QoL. The questionnaire should be filled in preoperatively and 18 months after surgery. Patients included in the longtime follow-up study described below are asked to answer the same questionnaire, which includes questions about the following:

* Arm morbidity: Pain, sensibility, swelling, restriction of movements, force
* Quality of life (EORTC QLQ-C30 and QLQ-BR23)
* Comorbidity - Charlsons Comorbidity Index
* Body Image
* Physiotherapy Part 2

Cohort study with 18 months follow-up. Patients are evaluated at baseline before surgery and after 18 months with the following methods:

* Passive Range of movement (pROM). The passive motion of both shoulders are measured in supine position by use of a goniometer: flexion, extension, abduction, inner and outer rotation
* Constant Shoulder Score (CSS). Including active Range of movement (aROM) in flexion, abduction, rotation and strengths during shoulder abduction in upright standing position with the IsoForceControl dynamometer
* Sensibility recording
* Arm circumference
* Arm volume - simplified water displacement method
* Cosmetic outcome - using clinical photos of the breast region (frontal- and side view) and estimation of BRA (Breast Retraction Assessment) Re. part 1 and 2

Inclusion:

Patients, who are undergoing breast conserving surgery for invasive breast cancer or carcinoma in situ by one of the three breast surgical units at hospitals in Central Denmark Region (Viborg, Randers, and Aarhus). They will be divided in the two groups:

* BCS including oncoplastic surgical techniques
* BCS without oncoplastic surgical techniques

Exclusion:

* Patients who are unable to sign an informed consent form
* Patients above the age of 75 years and under the age of 18 years.
* Patients who have previously been operated in the same or the contralateral breast, shoulder or arm Part 3 The study performed by Husted Madsen et al. in 2003-4 included in all 395 patients. Surviving patients from this cohort are asked to e new evaluation of shoulder and arm function following the same procedure as described in Part 1 and 2.

Statistics:

Based on previous experience and statistical calculations estimated that the investigators need 495 to participate in the questionnaire (Part 1) and 220 patient for the objective evaluation (Part 2) Further details can be added If requested.

Ethics:

Patients included in part 1 and 2 will be contacted in the breast units after confirmation of the diagnosis and after decision about the treatment has been made. Before inclusion oral and written information about the study are given and the patient is asked to sign an informed consent form. For part 3 of these studies, patients receive a letter invitation and these patients are also asked to sign an informed consent form before entering the study.

There is only minor discomfort associated with the objective evaluation and no major complications or side effects are expected.

The protocol is submitted to The Local Research Ethics Committee for Central Region Denmark for approval.

Shoulder Disability and Late Symptoms Following Oncoplastic Breast Surgery

Estimating arm lympoedema by the water displacement method and breast lymphoedema by clinical evaluation.

Comparing cosmetic results by clinical evaluation and photos including breast retraction assessment (BRA)

By measuring passive and active range of movement (ROM) in the shoulder, measuring strength by a dynamometer (IsoForceControl). Estimating Constant Shoulder Score.

Comparing EORTC QLQ-c30 and br23 before and 18 months after surgery.

Danish Cancer Society

University of Aarhus

Musculoskeletal Diseases

Nervous System Diseases

Shoulder Pain

Head and Neck Neoplasms

Arthralgia

Joint Diseases

Neurologic Manifestations

Brief intraoperative electrical stimulation of the spinal accessory nerve (ESSAN) continuously at 20 Hz, 10-15V for 60 minutes immediately following neck dissection.

No stimulation will be performed in this group, and patients will simply have the neck dissection as planned. No sham stimulation is required, as all outcome measures are performed by individuals not present in the operating room, and therefore, blinded to the treatment arm.

Electrical stimulation will be applied to the nerve using the Grass SD9 Stimulator at a frequency of 20Hz, 10-15V, for 60 minutes during the surgery. This will occur after the neck dissection has been completed, and the remainder of the surgery will continue during stimulation. The stimulation will be applied using the Grass SD9 Stimulator and the current will be conducted to the nerve using a sterile wire electrode that will be encircled around the nerve at its most proximally-exposed portion (skull base). The wire will be removed after 60 minutes of stimulation has been applied.

Grass SD9 Stimulator

Brittany Barber, MD

Daniel O'Connell, MD MSc FRCSC

Hadi Seikaly, MD MAL FRCSC

Ming Chan, MD FRCPC

Margaret McNeely, PT PhD

Jeffrey Harris, MD MHA FRCSC

Jaret Olson, MD FRCSC

Introduction: Shoulder pain and dysfunction is common after oncologic neck dissection for head and neck cancer (HNC). These symptoms can hinder postoperative rehabilitation and oral hygiene, activities of daily living (ADLs), and return to work after treatment. Due to the rising incidence of Human papillomavirus (HPV)-associated oropharyngeal cancer, patients are often diagnosed in the 3rd or 4th decade of life, leaving many potential working years lost. Brief electrical stimulation (BES) is a novel technique that has been shown to enhance neuronal regeneration after injury through a brain-derived neurotrophic growth factor (BDNF)-driven molecular pathway. The aim of this study is to examine the utility of intraoperative BES in prevention of shoulder pain and dysfunction after oncologic neck dissection.

Methods: All adult patients with a new diagnosis of HNC undergoing surgery with neck dissection including Level IIb and postoperative radiotherapy will be enrolled. Patients will undergo intraoperative BES after completion of neck dissection for 60 minutes continuously at 20 Hz with an intensity of 1.5 times the motor threshold. Postoperatively, patients will be evaluated using the Constant-Murley Shoulder Score, a scale that assesses shoulder pain, activities of daily living (ADLs), strength, and range of motion. Secondary outcomes measured will include scores on the Oxford Shoulder Score, the Neck Dissection Impairment Index (NDII), and the University of Washington Quality of Life (UW-QOL) score. Primary and secondary outcomes will be assessed at 1, 2, 3, 6, and 12 months postoperatively. Study and placebo groups will be compared using a Mann-Whitney analysis.

This study will be conducted as a randomized, double-blinded, placebo-controlled trial. Two parallel treatment groups will be examined with a 1:1 allocation: 1) brief intraoperative electrical stimulation continuously at 20 Hz at an intensity of 1.5 times the motor threshold for 60 minutes, or 2) sham/no stimulation for 60 minutes. Individuals will be allocated to treatment groups using a block randomization sequence. Participants and researchers measuring outcomes will be blinded to treatment groups. Stimulation (BES or sham) will occur intraoperatively immediately following neck dissection for 60 minutes.

Brief intraoperative electrical stimulation of the spinal accessory nerve (ESSAN) continuously at 20 Hz, 10-15V for 60 minutes immediately following neck dissection

Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection

Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection (ESSAN): a Double-blinded, Randomized Control Trial

The Constant-Murley score is a 100-point scale composed of a number of individual parameters, detailing the level of shoulder pain and the ability to carry out normal daily activities of the patient. The Constant-Murley Score is a 100-point scale composed of a number of individual parameters, designed to determine functionality after shoulder treatment. It includes includes 4 subscales that assess pain, activities of daily living, strength, and range of motion (forward elevation, external rotation, abduction, and internal rotation of the shoulder). A higher score indicates higher quality of function.

The OSS is a 12-item, multi-dimensional, self-report questionnaire regarding shoulder-specific daily activity in the previous 4 weeks.

The Neck Dissection Impairment Index (NDII), is a 10-item self-report questionnaire using a 5-point Likert scale for assessment of shoulder impairment after neck dissection.

This will include conduction velocity and amplitude as it relates to nerve injury during oncologic neck dissection.

This will pertain to electrophysiologic thresholds necessary to evoke a motor response from the trapezius and sternocleidomastoid, to evaluate nerve function.

This instrument will be used to asses quality of life (QOL) differences between the study and placebo groups following treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery	NCT05272904	Seroma	Quilting Conventional wo...	18 Years -	Canisius-Wilhelmina Hospital
Morbidity Following the Diagnosis and Treatment of Patients With Breast Cancer	NCT00027105	Breast Cancer Lymphedema Physical Therap... Shoulder		18 Years - 85 Years	National Institutes of Health Clinical Center (CC)
Shoulder Disability and Late Symptoms Following Oncoplastic Breast Surgery	NCT02159274	Breast Cancer Carcinoma in Si...		18 Years - 75 Years	University of Aarhus
The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery	NCT05272904	Seroma	Quilting Conventional wo...	18 Years -	Canisius-Wilhelmina Hospital
Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection	NCT02268344	Shoulder Pain Head Neck Cance...	Grass SD9 Stimu...	18 Years - 55 Years	University of Alberta
The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery	NCT05272904	Seroma	Quilting Conventional wo...	18 Years -	Canisius-Wilhelmina Hospital
The QUILT Study: Quilting Sutures in Patients Undergoing Breast Cancer Surgery	NCT05272904	Seroma	Quilting Conventional wo...	18 Years -	Canisius-Wilhelmina Hospital
Brief Intraoperative Electrical Stimulation for Prevention of Shoulder Dysfunction After Oncologic Neck Dissection	NCT02268344	Shoulder Pain Head Neck Cance...	Grass SD9 Stimu...	18 Years - 55 Years	University of Alberta

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