1.Safety Profile of Biportal Endoscopic Spine Surgery Compared to Conventional Microscopic Approach: A Pooled Analysis of 2 Randomized Controlled Trials
Sang-Min PARK ; Kwang-Sup SONG ; Dae-Woong HAM ; Ho-Joong KIM ; Min-Seok KANG ; Ki-Han YOU ; Choon Keun PARK ; Dong-Keun LEE ; Jin-Sung KIM ; Hong-Jae LEE ; Hyun-Jin PARK
Neurospine 2024;21(4):1190-1198
Objective:
To compare the safety profiles of biportal endoscopic spinal surgery (BESS) and microscopic spinal surgery (MSS) for lumbar disc herniation and spinal stenosis by analyzing the associated adverse events.
Methods:
We pooled data from 2 prospective randomized controlled trials involving 220 patients (110 in each group) who underwent single-level lumbar surgery. Participants aged 20–80 years with radiating pain due to lumbar disc herniation or spinal stenosis were included in this study. Adverse events were recorded and analyzed over a 12-month follow-up period.
Results:
The overall adverse event rates were 9.1% (10 of 110) in the BESS group and 17.3% (19 of 110) in the MSS group, which were not statistically significantly different (p=0.133). Notably, wound dehiscence occurred in 8.2% of MSS cases but in none of the BESS cases. Both groups showed similarly low rates of complications, such as dural tears, epidural hematoma, and nerve root injury. The most common adverse event in the BESS group was recurrent disc herniation (2.7%), whereas that in the MSS group was wound dehiscence (8.2%).
Conclusion
BESS demonstrated a safety profile comparable to that of MSS for the treatment of lumbar disc herniation and spinal stenosis, with a trend towards fewer overall complications. BESS offers particular advantages in terms of reducing wound-related complications. These findings suggest that BESS is a safe alternative to conventional MSS and potentially offers the benefits of a minimally invasive approach without compromising patient safety.
2.Safety Profile of Biportal Endoscopic Spine Surgery Compared to Conventional Microscopic Approach: A Pooled Analysis of 2 Randomized Controlled Trials
Sang-Min PARK ; Kwang-Sup SONG ; Dae-Woong HAM ; Ho-Joong KIM ; Min-Seok KANG ; Ki-Han YOU ; Choon Keun PARK ; Dong-Keun LEE ; Jin-Sung KIM ; Hong-Jae LEE ; Hyun-Jin PARK
Neurospine 2024;21(4):1190-1198
Objective:
To compare the safety profiles of biportal endoscopic spinal surgery (BESS) and microscopic spinal surgery (MSS) for lumbar disc herniation and spinal stenosis by analyzing the associated adverse events.
Methods:
We pooled data from 2 prospective randomized controlled trials involving 220 patients (110 in each group) who underwent single-level lumbar surgery. Participants aged 20–80 years with radiating pain due to lumbar disc herniation or spinal stenosis were included in this study. Adverse events were recorded and analyzed over a 12-month follow-up period.
Results:
The overall adverse event rates were 9.1% (10 of 110) in the BESS group and 17.3% (19 of 110) in the MSS group, which were not statistically significantly different (p=0.133). Notably, wound dehiscence occurred in 8.2% of MSS cases but in none of the BESS cases. Both groups showed similarly low rates of complications, such as dural tears, epidural hematoma, and nerve root injury. The most common adverse event in the BESS group was recurrent disc herniation (2.7%), whereas that in the MSS group was wound dehiscence (8.2%).
Conclusion
BESS demonstrated a safety profile comparable to that of MSS for the treatment of lumbar disc herniation and spinal stenosis, with a trend towards fewer overall complications. BESS offers particular advantages in terms of reducing wound-related complications. These findings suggest that BESS is a safe alternative to conventional MSS and potentially offers the benefits of a minimally invasive approach without compromising patient safety.
3.Safety Profile of Biportal Endoscopic Spine Surgery Compared to Conventional Microscopic Approach: A Pooled Analysis of 2 Randomized Controlled Trials
Sang-Min PARK ; Kwang-Sup SONG ; Dae-Woong HAM ; Ho-Joong KIM ; Min-Seok KANG ; Ki-Han YOU ; Choon Keun PARK ; Dong-Keun LEE ; Jin-Sung KIM ; Hong-Jae LEE ; Hyun-Jin PARK
Neurospine 2024;21(4):1190-1198
Objective:
To compare the safety profiles of biportal endoscopic spinal surgery (BESS) and microscopic spinal surgery (MSS) for lumbar disc herniation and spinal stenosis by analyzing the associated adverse events.
Methods:
We pooled data from 2 prospective randomized controlled trials involving 220 patients (110 in each group) who underwent single-level lumbar surgery. Participants aged 20–80 years with radiating pain due to lumbar disc herniation or spinal stenosis were included in this study. Adverse events were recorded and analyzed over a 12-month follow-up period.
Results:
The overall adverse event rates were 9.1% (10 of 110) in the BESS group and 17.3% (19 of 110) in the MSS group, which were not statistically significantly different (p=0.133). Notably, wound dehiscence occurred in 8.2% of MSS cases but in none of the BESS cases. Both groups showed similarly low rates of complications, such as dural tears, epidural hematoma, and nerve root injury. The most common adverse event in the BESS group was recurrent disc herniation (2.7%), whereas that in the MSS group was wound dehiscence (8.2%).
Conclusion
BESS demonstrated a safety profile comparable to that of MSS for the treatment of lumbar disc herniation and spinal stenosis, with a trend towards fewer overall complications. BESS offers particular advantages in terms of reducing wound-related complications. These findings suggest that BESS is a safe alternative to conventional MSS and potentially offers the benefits of a minimally invasive approach without compromising patient safety.
4.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
5.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
6.Safety Profile of Biportal Endoscopic Spine Surgery Compared to Conventional Microscopic Approach: A Pooled Analysis of 2 Randomized Controlled Trials
Sang-Min PARK ; Kwang-Sup SONG ; Dae-Woong HAM ; Ho-Joong KIM ; Min-Seok KANG ; Ki-Han YOU ; Choon Keun PARK ; Dong-Keun LEE ; Jin-Sung KIM ; Hong-Jae LEE ; Hyun-Jin PARK
Neurospine 2024;21(4):1190-1198
Objective:
To compare the safety profiles of biportal endoscopic spinal surgery (BESS) and microscopic spinal surgery (MSS) for lumbar disc herniation and spinal stenosis by analyzing the associated adverse events.
Methods:
We pooled data from 2 prospective randomized controlled trials involving 220 patients (110 in each group) who underwent single-level lumbar surgery. Participants aged 20–80 years with radiating pain due to lumbar disc herniation or spinal stenosis were included in this study. Adverse events were recorded and analyzed over a 12-month follow-up period.
Results:
The overall adverse event rates were 9.1% (10 of 110) in the BESS group and 17.3% (19 of 110) in the MSS group, which were not statistically significantly different (p=0.133). Notably, wound dehiscence occurred in 8.2% of MSS cases but in none of the BESS cases. Both groups showed similarly low rates of complications, such as dural tears, epidural hematoma, and nerve root injury. The most common adverse event in the BESS group was recurrent disc herniation (2.7%), whereas that in the MSS group was wound dehiscence (8.2%).
Conclusion
BESS demonstrated a safety profile comparable to that of MSS for the treatment of lumbar disc herniation and spinal stenosis, with a trend towards fewer overall complications. BESS offers particular advantages in terms of reducing wound-related complications. These findings suggest that BESS is a safe alternative to conventional MSS and potentially offers the benefits of a minimally invasive approach without compromising patient safety.
7.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
8.Safety Profile of Biportal Endoscopic Spine Surgery Compared to Conventional Microscopic Approach: A Pooled Analysis of 2 Randomized Controlled Trials
Sang-Min PARK ; Kwang-Sup SONG ; Dae-Woong HAM ; Ho-Joong KIM ; Min-Seok KANG ; Ki-Han YOU ; Choon Keun PARK ; Dong-Keun LEE ; Jin-Sung KIM ; Hong-Jae LEE ; Hyun-Jin PARK
Neurospine 2024;21(4):1190-1198
Objective:
To compare the safety profiles of biportal endoscopic spinal surgery (BESS) and microscopic spinal surgery (MSS) for lumbar disc herniation and spinal stenosis by analyzing the associated adverse events.
Methods:
We pooled data from 2 prospective randomized controlled trials involving 220 patients (110 in each group) who underwent single-level lumbar surgery. Participants aged 20–80 years with radiating pain due to lumbar disc herniation or spinal stenosis were included in this study. Adverse events were recorded and analyzed over a 12-month follow-up period.
Results:
The overall adverse event rates were 9.1% (10 of 110) in the BESS group and 17.3% (19 of 110) in the MSS group, which were not statistically significantly different (p=0.133). Notably, wound dehiscence occurred in 8.2% of MSS cases but in none of the BESS cases. Both groups showed similarly low rates of complications, such as dural tears, epidural hematoma, and nerve root injury. The most common adverse event in the BESS group was recurrent disc herniation (2.7%), whereas that in the MSS group was wound dehiscence (8.2%).
Conclusion
BESS demonstrated a safety profile comparable to that of MSS for the treatment of lumbar disc herniation and spinal stenosis, with a trend towards fewer overall complications. BESS offers particular advantages in terms of reducing wound-related complications. These findings suggest that BESS is a safe alternative to conventional MSS and potentially offers the benefits of a minimally invasive approach without compromising patient safety.
9.Development and Feasibility Assessment of Mobile ApplicationBased Digital Therapeutics for Postoperative Supportive Care in Gastric Cancer Patients Following Gastrectomy
Ji-Hyeon PARK ; Hyuk-Joon LEE ; JeeSun KIM ; Yo-Seok CHO ; Sunjoo LEE ; Seongmin PARK ; Hwinyeong CHOE ; Eunhwa SONG ; Youngran KIM ; Seong-Ho KONG ; Do Joong PARK ; Byung-Ho NAM ; Han-Kwang YANG
Journal of Gastric Cancer 2024;24(4):420-435
Purpose:
This study aimed to develop and assess the feasibility and effectiveness of digital therapeutics for supportive care after gastrectomy.Materials and Method: The study included 39 patients with gastric cancer who underwent minimally invasive gastrectomy and were able to use a mobile application (app) on their smartphones. The developed research app automatically calculates and provides daily targets for calorie and protein intake based on the patient’s body mass index (BMI). Patients recorded their daily diets, weights, and symptoms in the app and completed special questionnaires to assess the feasibility of the app in real-world clinical practice.
Results:
At the 10-week follow-up, the mean questionnaire scores for ease of learning, usability, and effectiveness of the app (primary endpoint) were 2.32±0.41, 2.35±0.43, and 2.4±0.39 (range: 0–3), respectively. Patients were classified as underweight (<18.5, n=4), normal (18.5–24.9, n=24), or overweight (≥25.0, n=11) according to predischarge BMI.Underweight patients showed higher compliance with app usage and a higher rate of achieving the target calorie and protein intake than normal weight and overweight patients (98% vs. 77% vs. 81%, p=0.0313; 102% vs. 75% vs. 61%, P=0.0111; 106% vs. 79% vs. 64%, P=0.0429). Two patients transitioned from underweight to normal weight (50.0%), one patient (4.3%) transitioned from normal weight to underweight, and two patients (22.2%) transitioned from overweight to normal weight.
Conclusions
The mobile app is feasible and useful for postoperative supportive care in terms of ease of learning, usability, and effectiveness. Digital therapeutics may be an effective way to provide supportive care for postgastrectomy patients, particularly in terms of nutrition.
10.Outcomes of Concomitant Maze Procedure in Tricuspid Repair for Severe Tricuspid Regurgitation
Ilkun PARK ; Suryeun CHUNG ; Yang Hyun CHO ; Kiick SUNG ; Wook Sung KIM ; Kyungsub SONG ; Joong Hyun AHN ; Chang Seok JEON ; Pyo Won PARK ; Dong Seop JEONG
Journal of Korean Medical Science 2024;39(15):e143-
Background:
We aimed to analyze the impact of concomitant Maze procedure on the clinical and rhythm outcomes, and echocardiographic parameters in tricuspid repair for patients with severe tricuspid regurgitation (TR) and persistent atrial fibrillation (AF).
Methods:
Patients who had severe TR and persistent AF and underwent tricuspid valve (TV) repair were included in the study. Both primary TR and secondary TR were included in the current study. The study population was stratified according to Maze procedure. The primary outcome was major adverse cardiovascular and cerebrovascular event (MACCE) at 15 years postsurgery. Propensity-score matching analyses was performed to adjust baseline differences.
Results:
Three hundred seventy-one patients who underwent tricuspid repair for severe TR and persistent AF from 1994 to 2021 were included, and 198 patients (53.4%) underwent concomitant Maze procedure. The maze group showed 10-year sinus rhythm (SR) restoration rate of 55%. In the matched cohort, the maze group showed a lower cumulative incidence of cardiac death (4.6% vs. 14.4%, P = 0.131), readmission for heart failure (8.1% vs. 22.2%, P = 0.073), and MACCE (21.1% vs. 42.1%, P = 0.029) at 15 years compared to the non-maze group. Left atrial (LA) diameter significantly decreased in the maze group at 5 years (53.3 vs. 59.6 mm, P < 0.001) after surgery compared to preoperative level, and there was a significant difference in the change of LA diameter over time between the two groups (P = 0.013).
Conclusion
The Maze procedure during TV repair in patients with severe TR and persistent AF showed acceptable SR rates and lower MACCE rates compared to those without the procedure, while also promoting LA reverse remodeling.

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