A randomized controlled phase III trial to evaluate the effect of preoperative enteral immunonutrition on the surgical site infection after total gastrectomy (OGSG0507).

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 74-74 ◽  
Author(s):  
Y. Kimura ◽  
T. Tsujinaka ◽  
K. Fujitani ◽  
J. Fujita ◽  
I. Miyashiro ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Surgical Site Infection ◽  
Total Gastrectomy ◽  
Proximal Gastrectomy ◽  
Infectious Complications ◽  
Phase Iii ◽  
Site Infection ◽  
Regular Diet ◽  
Randomized Controlled ◽  
Significant Difference

74 Background: To investigate the effect of preoperative enteral immunonutrion on the incidence of surgical site infection (SSI) after total gastrectomy for gastric cancer, we conducted a prospective randomized controlled trial. Methods: Eligibility criteria included: (1) histologically proven adenocarcinoma of stomach, (2) scheduled total gastrectomy, (3) aged less than 80 years, (4) not malnourished, (5) possible to ingest liquid diet, (6) written informed consent. Eligible patients (pts) wereassigned to the immunonutrition (I) group or the control (C) group. In the C group pts freely accessed to regular diet until surgery. In the I group, pts were supplemented with 1,000 ml/day of immunonutrient enriched with arginine, omega-3 fatty acids and RNA (Impact) in addition to the regular diet for 5 days before surgery. The primary endpoint was the incidence of SSI and the secondary endpoints were other infectious complications and serum CRP level on POD 3 or 4. Results: From 02/2004 to 12/2009, 240 gastric cancer patients (pts) who underwent gastric surgery were enrolled. 125 pts assigned to the I group and 115 pts assigned to the C group. Age, sex, body weight, serum albumin and general nutritional status were well balanced between the two groups. 223 pts underwent total gastrectomy, 6 pts proximal gastrectomy, 4 pts distal gastrectomy, and 7 pts simple laparotomy. In terms of tumor status, there were no significant difference between the groups in histological type, T stage, and lymph node metastasis. 104 of 125 pts assigned to the I group tolerated a daily intake 1,000 ml of Impact for 5 days. The incidence of SSI was 26 (20.8%) in the I group and 24 (20.9%) in the C group (R.R: 1.00, 95% C.I: 0.61-1.63). Postoperative morbidity was 36 (28.8%) in the I group and 30 (26.1%) in the C group. There was no difference in days of hospital stay after surgery between the groups. Conclusions: The oral administration of immunonutrient for 5 days before surgery did not contributed to the reduction of infectious complications after total gastrectomy in gastric cancer pts. No significant financial relationships to disclose.

scholarly journals Perioperative Prophylactic Antibiotics in Orthopaedic Surgery

2013 ◽  
Vol 3 (1) ◽  
pp. 5-10
Author(s):  
Bikram Prasad Shrestha ◽  
Surya Raj Niraula ◽  
Parvin Nepal ◽  
Guru Prasad Khanal ◽  
Navin Karn ◽  
...  
Keyword(s):  
Surgical Site Infection ◽  
Orthopaedic Surgery ◽  
Controlled Trial ◽  
Prophylactic Antibiotics ◽  
Drug Resistant ◽  
Site Infection ◽  
Oral Antibiotics ◽  
Randomized Controlled ◽  
Orthopaedic Patients ◽  
Significant Difference

Introduction: In our country, various institutes have different protocols for postoperative antibiotics. Many western literature have mentioned that administration of prophylactic antibiotics for longer than 24 hours has no advantage and may actually lead to superinfection with drug-resistant organisms. Because of environmental and theater condition most of the surgeon here are very reluctant to use prophylactic antibiotics for only 24 hours. The objective of the study was to find out the effect of duration of prophylactic antibiotics on the rate of surgical site infection in clean elective orthopaedic surgeries. Methods: This was a randomized controlled trial involving 207 clean elective orthopaedic patients undergoing surgery. The patients were divided into three groups which received intravenous prophylactic antibiotics for 24 hours, 48 hours and 48 hours followed by 7 days of oral antibiotics respectively. The patients were followed up for three months postoperatively. Result: There was no significant difference in the rate of surgical site infection among the three groups. Conclusion: We conclude that there is no benefit in prolonging prophylactic antibiotics beyond 24 hours. DOI: http://dx.doi.org/10.3126/noaj.v3i1.9318   Nepal Orthopedic Association Journal 2013 Vol.3(1): 5-10

scholarly journals Short-term and long-term comparisons of laparoscopy-assisted proximal gastrectomy with esophagogastrostomy by the double-flap technique and laparoscopy-assisted total gastrectomy for proximal gastric cancer

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0242223
Author(s):  
Tomoko Tsumura ◽  
Shinji Kuroda ◽  
Masahiko Nishizaki ◽  
Satoru Kikuchi ◽  
Yoshihiko Kakiuchi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Nutritional Status ◽  
Total Gastrectomy ◽  
Proximal Gastrectomy ◽  
Proximal Gastric Cancer ◽  
Short Term ◽  
Flap Technique ◽  
Significant Difference

Background Although proximal gastrectomy (PG) is a recognized surgical procedure for early proximal gastric cancer, total gastrectomy (TG) is sometimes selected due to concern about severe gastroesophageal reflux. Esophagogastrostomy by the double-flap technique (DFT) is an anti-reflux reconstruction after PG, and its short-term effectiveness has been reported. However, little is known about the long-term effects on nutritional status and quality of life (QOL). Methods Gastric cancer patients who underwent laparoscopy-assisted PG (LAPG) with DFT or laparoscopy-assisted TG (LATG) between April 2011 and March 2014 were retrospectively analyzed. Body weight (BW), body mass index (BMI), and prognostic nutritional index (PNI) were reviewed to assess nutritional status, and the Postgastrectomy Syndrome Assessment Scale (PGSAS)-45 was used to assess QOL. Results A total of 36 patients (LATG: 17, LAPG: 19) were enrolled. Four of 17 LATG patients (24%) were diagnosed with Stage ≥II after surgery, and half received S-1 adjuvant chemotherapy. BW and PNI were better maintained in LAPG than in LATG patients until 1-year follow-up. Seven of 16 LATG patients (44%) were categorized as “underweight (BMI<18.5 kg/m2)” at 1-year follow-up, compared to three of 18 LAPG patients (17%; p = 0.0836). The PGSAS-45 showed no significant difference in all QOL categories except for decreased BW (p = 0.0132). Multivariate analysis showed that LATG was the only potential risk factor for severe BW loss (odds ratio: 3.03, p = 0.0722). Conclusions LAPG with DFT was superior to LATG in postoperative nutritional maintenance, and can be the first option for early proximal gastric cancer.

scholarly journals The effect of peroperative erythrocyte transfusion on infectious complications in patients with gastric cancer undergoing curative gastrectomy

2021 ◽  
Vol 8 (2) ◽  
pp. 503
Author(s):  
Ahmet Sencer Ergin ◽  
Ogün Erşen ◽  
Ümit Mercan ◽  
Cemil Yüksel ◽  
Salim Demirci
Keyword(s):  
Gastric Cancer ◽  
Blood Transfusion ◽  
Surgical Site Infection ◽  
Infectious Complications ◽  
Site Infection ◽  
Curative Surgery ◽  
Curative Gastrectomy ◽  
Infection Incidence ◽  
Surgical Site Infection Incidence ◽  
Anastomosis Leakage

Background: In this study, the effect of perioperative blood transfusion on infectious complications in patients undergoing curative surgery for gastric adenocarcinoma was investigated.Methods: The clinicopathological results of 312 patients who underwent curative gastrectomy were retrospectively analyzed. The effect of blood transfusion on the development of postoperative infectious complications were statistically analyzed.Results: In the subgroup of patients with intraoperative transfusion, surgical site infection incidence was found to be significantly higher in patient with 2U above ES transfusions. (p=0.014). In the subgroup of patients with postoperative transfusion, hospital stay (p<0.001), postoperative CRP values (p<0.001), surgical site infection incidence (p=0.049) and anastomosis leakage incidence (p<0.001) were found to be significantly higher in patient with 2U above ES transfusions. In the subgroup of patients with both intraoperative and postoperative transfusion, SSI, anastomotic leakage and any infective complication incidences were found to be significantly higher in patients with 2U and above transfusions. In multivariate analysis, age (p=0.015), BMI (p=0.011), intraoperative transfusion (p=0.011) and both intraoperative and postoperative transfusion (p=0.045) were found to be independent risk factors for infective complications.Conclusions: It was found that performing peroperative ES transfusion is associated with increased rates of infectious complications in patients undergoing curative gastrectomy for gastric cancer by causing immunomodulation.

Proximal versus total gastrectomy for proximal gastric cancer: a Surveillance, Epidemiology, and End Results Program database analysis

2020 ◽  
Author(s):  
Jianchang Wei ◽  
Ping Yang ◽  
Qing Huang ◽  
Zhuanpeng Chen ◽  
Tong Zhang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Total Gastrectomy ◽  
Survival Curve ◽  
Clinical Stage ◽  
Proximal Gastrectomy ◽  
Tumor Stage ◽  
Tumor Differentiation ◽  
Proximal Gastric Cancer ◽  
Significant Difference ◽  
End Results

Aims: To addresses whether surgical procedure (proximal gastrectomy [PG] vs total gastrectomy [TG]) influences survival outcomes. Methods: Patients were selected from Surveillance, Epidemiology and End Results Program (SEER) database. Survival curve was used to evaluate the differences in overall survival (OS) and cancer-specific survival (CSS). Results: No significant difference was detected in OS and CSS time between PG and TG groups. Also, no significant differences were observed in OS and CSS times between the two groups with respect to clinical stage, tumor stage, node stage, age, gender and tumor differentiation. Tumor differentiation, tumor size, tumor stage, node stage and age were independent prognostic factors in patients with proximal gastric cancer. Conclusions: TG was not necessary for proximal gastric cancer patients, and PG may be considered as an ideal surgery approach.

SUN-PP142: Sarcopenic Obesity: A Predictor of Surgical Site Infection following Total Gastrectomy for Gastric Cancer

2015 ◽  
Vol 34 ◽  
pp. S76
Author(s):  
T. Nishigori ◽  
S. Tsunoda ◽  
H. Okabe ◽  
K. Hirai ◽  
R. Takahashi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Surgical Site Infection ◽  
Total Gastrectomy ◽  
Sarcopenic Obesity ◽  
Site Infection

A randomized phase III trial to determine the efficacy of postoperative antimicrobial prophylaxis in gastric cancer surgery (OGSG0501)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15576-e15576
Author(s):  
K. Inoue ◽  
H. Imamura ◽  
Y. Kimura ◽  
K. Fujitani ◽  
Y. Miyake ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Surgical Site Infection ◽  
Infection Rate ◽  
Distal Gastrectomy ◽  
Antimicrobial Prophylaxis ◽  
Cancer Surgery ◽  
Phase Iii ◽  
Site Infection ◽  
Phase Iii Trial ◽  
Gastric Cancer Surgery

e15576 Background: In Japan, antimicrobial prophylaxis (AMP) is typically administered for 3 to 4 days postoperatively in gastric cancer surgery. This far exceeds the recommended 24h or less laid out by the Centers for Disease Control (CDC) guidelines for the prevention of surgical-site infections, after a clean-contaminated operation. Methods: A multicenter randomized phase III trial was designed to evaluate the effect of postoperative AMP in gastric cancer surgery. Patients (pts) were required to have histologically proven gastric cancer which was curable by distal gastrectomy, be classifiable as ASA 1 or 2, and have adequate organ function. Pts were randomized to: (A) perioperative AMP (cefazolin 1g, at <30min before incision, every 3h intraoperative supplements) plus postoperative AMP (cefazolin 1g, twice daily for 2 postoperative days) or (B) perioperative AMP alone. Pts were stratified by institution and ASA. The primary endpoint was the incidence of surgical site infection (SSI). With 171 pts per arm, this study had 80% power to demonstrate non-inferiority with 5% margin of peri-AMP alone and 0.05 1-sided alpha. Results: 355 patients were recruited (A: 179, B: 176) in 7 centers between June 2005 and December 2007. The surgical-site infection rate was 9.0 percent (16 of 178) for peri-/post AMP and 4.5 percent (8 of 176) for peri-AMP alone, with no significant differences (Fisher's exact test: P=0.14, RR=1.98 [95%CI, 0.89–4.44]), but showing a significant non-inferiority (P<0.001). The remote site infection rate was 3.4 percent (6 of 178) for peri-/post AMP and 5.1 percent (9 of 175) for peri-AMP alone, with no significant differences (P=0.44, RR=0.66 [95%CI, 0.25- 1.70]). Conclusions: This multicenter randomized phase III trial confirms that postoperative AMP is unnecessary in patients undergoing distal gastrectomy for gastric cancer. No significant financial relationships to disclose.

Randomized controlled phase III trial to investigate superiority of robot-assisted gastrectomy over laparoscopic gastrectomy for clinical stage T1-2N0-2 gastric cancer patients: Japan Clinical Oncology Group study JCOG1907 (MONA LISA study).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS254-TPS254
Author(s):  
Rie Makuuchi ◽  
Mitsumi Terada ◽  
Junki Mizusawa ◽  
Masanori Tokunaga ◽  
Kei Hosoda ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Postoperative Complications ◽  
Laparoscopic Gastrectomy ◽  
Patient Survival ◽  
Infectious Complications ◽  
Phase Iii ◽  
Controlled Trials ◽  
Robot Assisted ◽  
Phase Iii Trial ◽  
Randomized Controlled

TPS254 Background: Postoperative complications reportedly affect oncological outcomes in various cancers according to the timing of adjuvant chemotherapy and by influencing the immune function. Particularly, postoperative intra-abdominal infectious complications, including intra-abdominal abscess, pancreatic fistula, and anastomotic leakage, have been identified as prognostic factors for gastric cancer. Given the negative impact of such complications on patient survival, considering the short- and long-term outcomes, it is important to develop surgical procedures with fewer complications. In Japan, laparoscopic gastrectomy is a standard treatment modality for early gastric cancer. Randomized controlled trials have shown that laparoscopic gastrectomy is relatively less invasive and has similar postoperative complications and non-inferior patient survival rates when compared with open gastrectomy. However, several challenges associated with the procedure need to be overcome, such as the limited movement of the forceps. Robot-assisted gastrectomy allows surgeons to perform more meticulous surgical interventions with articulated devices; therefore, reducing the possibility of postoperative complications, as demonstrated by a few prospective studies performed in Japan. However, a non-randomized controlled trial conducted in Korea reported that there were no benefits of robot-assisted gastrectomy in terms of postoperative complications. Furthermore, no randomized controlled trials have directly compared robot-assisted and laparoscopic gastrectomy to provide solid evidence regarding the merits of the former. Methods: To confirm the superiority of robot-assisted gastrectomy over laparoscopic gastrectomy for patients with cT1-2N0-2M0 gastric cancer, we designed JCOG1907 (UMIN000039825) as a multicenter randomized phase III trial. In the standard arm, we performed laparoscopic gastrectomy with lymphadenectomy, while in the experimental arm, we performed robot-assisted gastrectomy with lymphadenectomy. The primary endpoint is the incidence of postoperative intra-abdominal infectious complications of Clavien–Dindo classification grade ≥II. Major secondary endpoints are relapse-free survival, overall survival, overall postoperative complications, and short-term clinical outcomes after gastrectomy. The planned sample size is 1040 participants, with a one-sided alpha of 5% and a power of 70%, with an expected 3% decrease in postoperative intra-abdominal infectious complications (6% vs. 3%). Over the period of 5 years, patients will be enrolled from 35 Japanese institutions. Enrollment has started in March 2020, and as of August 2020, 30 patients have already been enrolled. Clinical trial information: UMIN000039825.

scholarly journals Is there a need for antibiotic cover in clean surgery like laparoscopic cholecystectomy: a prospective study

2020 ◽  
Vol 7 (3) ◽  
pp. 797
Author(s):  
Vishwanath Pai ◽  
Sana Aboosalih ◽  
S. N. Saravana Sundaram ◽  
Ann Rhoda Abraham ◽  
K. R. Manoj Prabhu
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Prospective Study ◽  
Surgical Site Infection ◽  
Financial Burden ◽  
Prophylactic Antibiotic ◽  
Infectious Complications ◽  
Site Infection ◽  
Duration Of Symptoms ◽  
Significant Difference ◽  
Duration Of Surgery

Background: Even with a low post-operative infection complication rate in elective laparoscopic cholecystectomy (LC), most surgeons use prophylactic antibiotics out of habit. This prospective study was done to analyze the need for such prophylaxis in cases of elective LC.Methods: 135 successive patients undergoing elective LC were included in the study. Patients were randomized into 3 groups. Group A (n=45) cases received 3 doses of injection ceftriaxone in the post op period, group B (n=48) cases received a single dose of injection ceftriaxone at the time of induction of anesthesia, and group C (n=42) cases did not receive any antibiotic pre or post operatively. Post-operative infectious complications between three groups were compared.Results: There was no significant difference in surgical site infection rates between the groups for variables such as age, sex, body mass index, duration of symptoms, duration of surgery and hospital stay. Intraoperative spillage of bile [6.7% (A): 4.6% (B): 5.2% (C)] did not increase infectious complications.Conclusions: Routine use of prophylactic antibiotic in a clean, uncomplicated cases of laparoscopic cholecystectomy is not required. One dose of ceftriaxone at the time of induction or 3 doses of injection ceftriaxone post operatively following elective LC even in the urban Indian setting should be abandoned as it neither reduces the rate of surgical site infection but also contributes to adverse reactions, drug resistance, and unnecessary financial burden.

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