Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426810
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-07
Brief Title:
Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx
Sponsor:
SMG-SNU Boramae Medical Center
Organization:
SMG-SNU Boramae Medical Center
Study Overview
Official Title:
A Prospective Randomized Study Comparing Electrosurgical Bipolar Systems Versus Conventional Electrocautery After Sentinel Lymph Node Biopsy in Obese or Preoperative Chemotherapy Treated Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The efficacy of electrosurgical bipolar systems in axillary lymph node dissection for breast cancer surgery is well known In this study the investigators aim to determine whether using electrosurgical bipolar systems helps reduce seroma formation in high-risk patients undergoing sentinel lymph node biopsy SLNB for breast cancer surgery The investigators will focus on patients who are expected to experience high drainage output after SLNB especially those who are obese BMI25 or have undergone preoperative chemotherapy
Detailed Description:
The most common complications of breast cancer surgery are lymphorrhea and seroma Seroma increases the length of hospital stay the duration of outpatient treatment and patient discomfort Persistent seroma can lead to re-hospitalization due to wound infection caused by repeated aspirations Seroma generally occurs in 10 to 85 of cases after breast cancer surgery Risk factors associated with seroma or lymphorrhea identified in previous studies include age over 60 high BMI tumor size preoperative chemotherapy extent of breast tissue resection number of lymph nodes removed and number of lymph node metastases
Efforts to reduce seroma after breast cancer surgery include meticulous techniques such as sharp dissection the use of monopolar energy devices and ligation of blood vessels and lymphatics Recently the bipolar energy sealing system has been increasingly used LigaSure which uses electric energy and pressure to denature collagen and elastin in tissue has been shown to reduce surgical time and medical costs compared to traditional clamp-and-tie methods and advanced sealing systems in various surgeries including breast cancer
In breast cancer surgery using a electrosurgical bipolar systems for ligating blood vessels and lymph nodes has several potential advantages Traditional ligation using sutures or monopolar energy devices can be influenced by surgical technique and has drawbacks such as thermal injury to surrounding tissue In contrast the bipolar energy sealer applies both electric energy and pressure simultaneously minimizing thermal injury to surrounding tissue while ensuring permanent vessel and lymphatic ligation
A 2008 prospective study showed that using bipolar energy sealers in axillary dissection allowed for earlier removal of drains compared to conventional methods Other studies have shown less blood loss lower drainage output and shorter hospital stays during surgery Recent research has also reported new applications of bipolar energy sealers in skin-sparing mastectomy indicating active use in breast surgery overseas A study conducted at Severance Hospital in South Korea found that using bipolar energy sealers reduced drainage
However most of these studies were conducted abroad with a small number of reported cases and the results mainly concern axillary lymph node dissection ALND which is where seroma is most often formed With the decreasing trend of ALND due to advances in preoperative chemotherapy and radiotherapy there is a lack of studies on whether using electrosurgical bipolar systems helps reduce seroma formation after sentinel lymph node biopsy
Efforts to reduce seroma after breast cancer surgery include meticulous techniques such as sharp dissection the use of monopolar energy devices and ligation of blood vessels and lymphatics Recently the bipolar energy sealing system has been increasingly used LigaSure which uses electric energy and pressure to denature collagen and elastin in tissue has been shown to reduce surgical time and medical costs compared to traditional clamp-and-tie methods and advanced sealing systems in various surgeries including breast cancer
In breast cancer surgery using a electrosurgical bipolar systems for ligating blood vessels and lymph nodes has several potential advantages Traditional ligation using sutures or monopolar energy devices can be influenced by surgical technique and has drawbacks such as thermal injury to surrounding tissue In contrast the bipolar energy sealer applies both electric energy and pressure simultaneously minimizing thermal injury to surrounding tissue while ensuring permanent vessel and lymphatic ligation
A 2008 prospective study showed that using bipolar energy sealers in axillary dissection allowed for earlier removal of drains compared to conventional methods Other studies have shown less blood loss lower drainage output and shorter hospital stays during surgery Recent research has also reported new applications of bipolar energy sealers in skin-sparing mastectomy indicating active use in breast surgery overseas A study conducted at Severance Hospital in South Korea found that using bipolar energy sealers reduced drainage
However most of these studies were conducted abroad with a small number of reported cases and the results mainly concern axillary lymph node dissection ALND which is where seroma is most often formed With the decreasing trend of ALND due to advances in preoperative chemotherapy and radiotherapy there is a lack of studies on whether using electrosurgical bipolar systems helps reduce seroma formation after sentinel lymph node biopsy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None