Safety and Efficacy of Long Limb Roux-en Y Reconstruction

For the evaluation of long-term safety, albumin was measured to determine malnutrition.

Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.

For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)). HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin.

Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.

Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.

For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected. \*Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix d (for 'disability') is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication. For the evaluation of long-term safety, the patients were evaluated every month after discharge.

Time frame: Until end of study (on average 14.8 months)

Population: All of enrolled patient were included. (N=15)

Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.

Time frame: Until end of study (on average 14.8 months)

Population: All of enrolled patient were included.(N=15)

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c \< 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety.

Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of albumin level after operation for the evaluation of long-term safety in good responder group.

BMI(Body Mass index , kg/㎡) was measured. BMI was obtained using the following formula: Weight (kg) / (Height (m) x Height (m))

Time frame: Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c \< 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of weight change after operation in good response group. BMI(Body Mass index , kg/㎡) was measured. BMI was obtained using the following formula: Weight (kg) / (Height (m) x Height (m))

Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of weight after operation in good responder group.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c \< 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of HbA1c after operation in good response group. HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin.

Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of HbA1c after operation in good responder group.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c \< 6% without any antidiabetic medications. We called this group as good response group. For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group.

Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of hemoglobin after operation in good responder group for the evaluation of long-term safety.

HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured. HOMA-B was obtained using the following formula: 225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)

Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c \< 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured. HOMA-B was obtained using the following formula: 225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)

Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of beta cell function after operation in good responder group.

HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured. HOMA-IR was obtained using the following formula: Glucose(mg/dl) x Insulin/405

Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c \< 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of insulin resistance after operation in good response group. HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured. HOMA-IR was obtained using the following formula: Glucose(mg/dl) x Insulin/405

Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of HOMA-IR after operation in good responder group.

Matsuda Index(Insulin Sensitivity Index) was measured. The Matsuda index was obtained using the following formula: Matsuda index = 10000/square root of \[(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)\]

Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c \< 6% without any antidiabetic medications after operation. We called this group as good response group. We analyzed the change of insulin sensitivity after operation in good response group. The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula: Matsuda index = 10000/square root of \[(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)\]

Time frame: Before operation , 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of insulin sensitivity after operation in good responder group.

The quantitative insulin sensitivity check index (QUICKI) was measured. The QUICKI was obtained using the following formula: 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))

Time frame: Before operation , 6 months after operation , Until end of study (on average 14.8 months)

Population: Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.

At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c \< 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured. The QUICKI is obtained using the following formula: 1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))

Time frame: Before operation, 6 months after operation, Until end of study (on average 14.8 months)

Population: At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Normal FPG level and HbA1c \< 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of QUICKI after operation in good responder group.