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This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding, surgeons' satisfaction.
The patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons
This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. This is a randomized controlled trial comparing deep NMB with moderate NMB in laparoscopic subtotal gastrectomy in obese patients with gastric cancer. The design of the study is blinded (the surgical team and the research team are all blinded to the treatment); the attending anesthesiologist is not blinded. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding, surgeons' satisfaction.
The patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep neuromuscular block group | Experimental | Sugammadex sodium 4mg/kg/IV after operation |
|
| Moderate neuromuscular group | Experimental | Sugammadex sodium 2mg/kg/IV after operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex Sodium | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Retrieved Lymph Nodes Per Participant | Number of retrieved lymph nodes per participant, which was reported on final pathology report, after completing the laparoscopic surgery | within 14 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Rating Score (SRS) | Surgical rating score (SRS) at Four anatomical area during LN dissection During surgery, the surgeon reported the SRS based on the Leiden surgical rating scale (1=extremely poor, 2=poor, 3=acceptable, 4=good, 5=optimal) for each anatomical landmark (LN stations 4sb, 6, and 5 and the suprapancreatic area). | immediately after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung soo Park, MD,PhD | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35213496 | Derived | Park SH, Huh H, Choi SI, Kim JH, Jang YJ, Park JM, Kwon OK, Jung MR, Jeong O, Lee CM, Min JS, Kim JJ, An L, Yang KS, Park S, Lee IO; Deep Neuromuscular Block on Oncologic Quality of Laparoscopic Surgery in Obese Gastric Cancer Patients (DEBLOQS_GC) Study Group. Impact of the Deep Neuromuscular Block on Oncologic Quality of Laparoscopic Surgery in Obese Gastric Cancer Patients: A Randomized Clinical Trial. J Am Coll Surg. 2022 Mar 1;234(3):326-339. doi: 10.1097/XCS.0000000000000061. | |
| 30544421 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Deep Neuromuscular Block Group | Sugammadex sodium 4mg/kg/IV after operation Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. 2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. |
| FG001 | Moderate Neuromuscular Group | Sugammadex sodium 2mg/kg/IV after operation Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. 2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Ten patients were excluded from the deep neuromuscular block group (7: protocol violation, 3: withdrew consent) and 5 patients were excluded from the moderate neuromuscular block group (3: protocol violation, 2: withdrew consent).
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| ID | Title | Description |
|---|---|---|
| BG000 | Deep Neuromuscular Block Group | Sugammadex sodium 4mg/kg/IV after operation Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. 2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The effect of "Age" on oncological quality should be also considered. So, we categorize the patient according to "Age". Age is an important factor when considering phenotypic changes in health and disease. Age-related physiological changes can affect pharmacokinetics and pharmacodynamics of the drug. Typically, clinical trials categorize patients according to the age of 18 and 65 years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Retrieved Lymph Nodes Per Participant | Number of retrieved lymph nodes per participant, which was reported on final pathology report, after completing the laparoscopic surgery | This study originally intended to analyze whether a deeper depth of NMB can increase the number of retried LNs in obese gastric cancer patients. We tried to find a certain BMI point where the mean number of LNs showed a significant difference depending on the depth of NMB. BMI 28 was the starting point for the difference in the mean number of retrieved LNs. | Posted | Mean | Standard Deviation | lymph nodes | within 14 days after operation |
|
Adverse event within 6 months were reported for every patients during outpatient clinic follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deep Neuromuscular Block Group | Sugammadex sodium 4mg/kg/IV after operation Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. 2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shin Hoo Park | Korea university Anam Hospital | +82-10-6735-1824 | bulsajo333@hanmail.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2020 | Apr 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
|
| Number of Participants With at Least One Interruption Event | Interrupted event by patient movement, coughing, muscle spasm during operation | immediately after surgery |
| Intraoperative Blood Loss Amount | Amount of bleeding during operation | immediately after the operation |
| Derived |
| Lee Y, Ha D, An L, Jang YJ, Huh H, Lee CM, Kim YH, Kim JH, Park SH, Mok YJ, Lee IO, Kwon OK, Kwak KH, Min JS, Kim EJ, Choi SI, Yi JW, Jeong O, Jung MR, Bae HB, Park JM, Jung YH, Kim JJ, Kim DA, Park S. Comparison of oncological benefits of deep neuromuscular block in obese patients with gastric cancer (DEBLOQS_GC study): A study protocol for a double-blind, randomized controlled trial. Medicine (Baltimore). 2018 Dec;97(49):e13424. doi: 10.1097/MD.0000000000013424. |
| BG001 | Moderate Neuromuscular Group | Sugammadex sodium 2mg/kg/IV after operation Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. 2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | We tried to evaluate the impact of depth of neuromuscular block on oncological quality of laparoscopic surgery. In this circumstances, the effect of gender on oncological quality should be also evaluated. So, we categorize the patient according to "Sex". | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index (kg/m^2) | Obesity hinders laparoscopic procedures and impedes oncological safety during laparoscopic cancer surgery. We aimed to evaluate whether deep neuromuscular block improves oncologic quality of laparoscopic cancer surgery in obese patients. So, we checekd wheter there is any difference in BMI between two groups. | Mean | Standard Deviation | Body mass index (kg/m^2) |
|
| ASA classification | The American Society of Anesthesiologists (ASA) physical status classification offers clinicians a simple categorization of a patient's physiological status that can be helpful in predicting operative risk
| Count of Participants | Participants |
|
| OG001 | Moderate Neuromuscular Group | Sugammadex sodium 2mg/kg/IV after operation Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. 2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. |
|
|
| Secondary | Surgical Rating Score (SRS) | Surgical rating score (SRS) at Four anatomical area during LN dissection During surgery, the surgeon reported the SRS based on the Leiden surgical rating scale (1=extremely poor, 2=poor, 3=acceptable, 4=good, 5=optimal) for each anatomical landmark (LN stations 4sb, 6, and 5 and the suprapancreatic area). | Posted | Mean | Standard Deviation | score on a scale | immediately after the operation |
|
|
|
| Secondary | Number of Participants With at Least One Interruption Event | Interrupted event by patient movement, coughing, muscle spasm during operation | Posted | Count of Participants | Participants | immediately after surgery |
|
|
|
| Secondary | Intraoperative Blood Loss Amount | Amount of bleeding during operation | Posted | Median | Full Range | mL | immediately after the operation |
|
|
|
| 0 |
| 98 |
| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | Moderate Neuromuscular Group | Sugammadex sodium 2mg/kg/IV after operation Sugammadex Sodium: 1. INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion. 2. DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. | 0 | 98 | 0 | 98 | 0 | 98 |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| ASA III |
|
| SRS in LN #6 |
|
| SRS in supra-pancreatic area |
|
| Average SRS from 4 area |
|