The Learning Curve for Laparoscopic Subtotal Gastrectomy With D II Limphadenectomy. Results of a Pilot Randomized Controlled Clinical Trial
EAES Academy. Homorogan E. 07/05/22; 363166; P211
Estera Cristina Homorogan
Contributions
Contributions
Abstract
Aim:
We aim to define the learning curve for laparoscopic subtotal gastrectomy with D II limphadenectomy (LStG-DII) in an experienced laparoscopic surgical center and analyze the early results obtained by LStG-DII performed during the learning curve. Methods: We designed a randomized active-controlled, single-center, hospital-based, two arms pilot study over a period of one year. The informed consent process was carried out for all patients with distal gastric cancer admitted to our clinic. Inclusion criteria were defined as: acceptance of informed consent process, distal gastric tumors clinically staged as T1, 2 or 3 and N0 or 1, with M0 and a maximum ASA risk of ASA III. Exclusion criteria were: refusal to accept the terms of the informed consent, previous abdominal surgery, advanced loco-regional or metastatic disease, patients classified as ASA IV or above. Patients were randomized using block randomization technique. Results: We analyzed the intraoperative blood loss, surgery duration, intraoperative incidents, oncological radicality, number of limph nodes, mortality, morbidity and lenght of stay for the laparoscopic procedure and compared the results with those of the open procedure performed by the same surgeons after mastering the open surgery learning curve. 18 patients were included in this pilot study, nine for each treatment group. Statistical analysis was carried out using chi-square and Fisher’s exact tests and were considered significant if p < 0.05. Results showed that blood loss and duration of surgery were significantly higher for the laparoscopic group (p = 0.0149 and 0.0017 respectively). Postoperative mortality and morbidity were evaluated using the Clavien-Dindo classification and showed no overall significant differences, while open approach had a significantly higher percentage of grade I and II complications (p < 0.05). All the other variables analyzed showed no significant differences between the two groups. Conclusions: Although in the initial stages of the learning curve, results showed that LStG-DII is a feasible and safe procedure, when compared to the better established open approach, requiring the mastering of the learning curve in order to eliminate the significant differences.
We aim to define the learning curve for laparoscopic subtotal gastrectomy with D II limphadenectomy (LStG-DII) in an experienced laparoscopic surgical center and analyze the early results obtained by LStG-DII performed during the learning curve. Methods: We designed a randomized active-controlled, single-center, hospital-based, two arms pilot study over a period of one year. The informed consent process was carried out for all patients with distal gastric cancer admitted to our clinic. Inclusion criteria were defined as: acceptance of informed consent process, distal gastric tumors clinically staged as T1, 2 or 3 and N0 or 1, with M0 and a maximum ASA risk of ASA III. Exclusion criteria were: refusal to accept the terms of the informed consent, previous abdominal surgery, advanced loco-regional or metastatic disease, patients classified as ASA IV or above. Patients were randomized using block randomization technique. Results: We analyzed the intraoperative blood loss, surgery duration, intraoperative incidents, oncological radicality, number of limph nodes, mortality, morbidity and lenght of stay for the laparoscopic procedure and compared the results with those of the open procedure performed by the same surgeons after mastering the open surgery learning curve. 18 patients were included in this pilot study, nine for each treatment group. Statistical analysis was carried out using chi-square and Fisher’s exact tests and were considered significant if p < 0.05. Results showed that blood loss and duration of surgery were significantly higher for the laparoscopic group (p = 0.0149 and 0.0017 respectively). Postoperative mortality and morbidity were evaluated using the Clavien-Dindo classification and showed no overall significant differences, while open approach had a significantly higher percentage of grade I and II complications (p < 0.05). All the other variables analyzed showed no significant differences between the two groups. Conclusions: Although in the initial stages of the learning curve, results showed that LStG-DII is a feasible and safe procedure, when compared to the better established open approach, requiring the mastering of the learning curve in order to eliminate the significant differences.
Aim:
We aim to define the learning curve for laparoscopic subtotal gastrectomy with D II limphadenectomy (LStG-DII) in an experienced laparoscopic surgical center and analyze the early results obtained by LStG-DII performed during the learning curve. Methods: We designed a randomized active-controlled, single-center, hospital-based, two arms pilot study over a period of one year. The informed consent process was carried out for all patients with distal gastric cancer admitted to our clinic. Inclusion criteria were defined as: acceptance of informed consent process, distal gastric tumors clinically staged as T1, 2 or 3 and N0 or 1, with M0 and a maximum ASA risk of ASA III. Exclusion criteria were: refusal to accept the terms of the informed consent, previous abdominal surgery, advanced loco-regional or metastatic disease, patients classified as ASA IV or above. Patients were randomized using block randomization technique. Results: We analyzed the intraoperative blood loss, surgery duration, intraoperative incidents, oncological radicality, number of limph nodes, mortality, morbidity and lenght of stay for the laparoscopic procedure and compared the results with those of the open procedure performed by the same surgeons after mastering the open surgery learning curve. 18 patients were included in this pilot study, nine for each treatment group. Statistical analysis was carried out using chi-square and Fisher’s exact tests and were considered significant if p < 0.05. Results showed that blood loss and duration of surgery were significantly higher for the laparoscopic group (p = 0.0149 and 0.0017 respectively). Postoperative mortality and morbidity were evaluated using the Clavien-Dindo classification and showed no overall significant differences, while open approach had a significantly higher percentage of grade I and II complications (p < 0.05). All the other variables analyzed showed no significant differences between the two groups. Conclusions: Although in the initial stages of the learning curve, results showed that LStG-DII is a feasible and safe procedure, when compared to the better established open approach, requiring the mastering of the learning curve in order to eliminate the significant differences.
We aim to define the learning curve for laparoscopic subtotal gastrectomy with D II limphadenectomy (LStG-DII) in an experienced laparoscopic surgical center and analyze the early results obtained by LStG-DII performed during the learning curve. Methods: We designed a randomized active-controlled, single-center, hospital-based, two arms pilot study over a period of one year. The informed consent process was carried out for all patients with distal gastric cancer admitted to our clinic. Inclusion criteria were defined as: acceptance of informed consent process, distal gastric tumors clinically staged as T1, 2 or 3 and N0 or 1, with M0 and a maximum ASA risk of ASA III. Exclusion criteria were: refusal to accept the terms of the informed consent, previous abdominal surgery, advanced loco-regional or metastatic disease, patients classified as ASA IV or above. Patients were randomized using block randomization technique. Results: We analyzed the intraoperative blood loss, surgery duration, intraoperative incidents, oncological radicality, number of limph nodes, mortality, morbidity and lenght of stay for the laparoscopic procedure and compared the results with those of the open procedure performed by the same surgeons after mastering the open surgery learning curve. 18 patients were included in this pilot study, nine for each treatment group. Statistical analysis was carried out using chi-square and Fisher’s exact tests and were considered significant if p < 0.05. Results showed that blood loss and duration of surgery were significantly higher for the laparoscopic group (p = 0.0149 and 0.0017 respectively). Postoperative mortality and morbidity were evaluated using the Clavien-Dindo classification and showed no overall significant differences, while open approach had a significantly higher percentage of grade I and II complications (p < 0.05). All the other variables analyzed showed no significant differences between the two groups. Conclusions: Although in the initial stages of the learning curve, results showed that LStG-DII is a feasible and safe procedure, when compared to the better established open approach, requiring the mastering of the learning curve in order to eliminate the significant differences.
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