International consensus on a complications list after gastrectomy for cancer

Baiocchi, Gian Luca; Giacopuzzi, Simone; Marrelli, Daniele; Reim, Daniel; Piessen, Guillaume; Costa, Paulo; Reynolds, John V.; Meyer, Hans; Morgagni, Paolo; Gockel, Ines; Santos, Lúcio Lara; Jensen, Lone Susanne; Murphy, Thomas J.; Preston, Shaun R.; Тер-Ованесов, М. Д.; Romario, Uberto Fumagalli; Degiuli, Maurizio; Kielan, Wojciech; Mönig, Stefan P.; Kołodziejczyk, Piotr; Polkowski, Wojciech; Hardwick, Richard; Pera, Manuel; Johansson, Jan; Schneider, Paul M.; Steur, Wobbe O. de; Gisbertz, Suzanne S.; Hartgrink, Henk H.; Sandick, J. W. van; Portolani, Nazario; Hölscher, A. H.; Botticini, Maristella; Roviello, Franco; Mariette, C.; Allum, William; Manzoni, Giovanni De

doi:10.1007/s10120-018-0839-5

Cited by 97 publications

(93 citation statements)

References 31 publications

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“…Secondary outcomes included OS, DFS, operative time, R0 rate, number of lymph nodes harvested, time to first flatus, length of hospital stay, and readmission rate. Gastro/esophagojejunostomy leak was defined as reported in the International Consensus on complications after gastrectomy for gastric cancer . OS was defined as the period from surgery to the date of cancer‐related death.…”

Section: Methodsmentioning

confidence: 99%

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Robotic vs open gastrectomy for gastric cancer: A propensity score‐matched analysis on short‐ and long‐term outcomes

Solaini

Bazzocchi

Pellegrini

et al. 2019

Robotics Computer Surgery

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Background The aim of this study was compare short‐ and long‐term outcomes between robotic (RG) and standard open gastrectomy (OG). Methods This is a single‐center propensity score‐matched study including patients who underwent RG or OG for gastric cancer between 2008 and 2018. Results In total, 191 patients could be included for analysis. Of 60 RG patients, 49 could be matched. After matching, significant differences in baseline characteristics were no longer present. Operative time was significantly longer (451 min, IQR: 392‐513) in the RG group than in the OG (262 min, IQR: 225‐330) (P < .0001). No significant differences in postoperative complications between RG (n = 15, 30.6%) and OG (n = 15, 30.6%) were seen (P = 1.000). Overall survival was comparable between the groups. Conclusions RG is feasible and safe. With regard to long‐term oncologic outcomes, survivals in the RG group were similar to those in OG group.

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Section: Methodsmentioning

confidence: 99%

“…Gastro/esophagojejunostomy leak was defined as reported in the International Consensus on complications after gastrectomy for gastric cancer. 16…”

Section: Perioperative Care and Proceduresmentioning

confidence: 99%

Robotic vs open gastrectomy for gastric cancer: A propensity score‐matched analysis on short‐ and long‐term outcomes

Solaini

Bazzocchi

Pellegrini

et al. 2019

Robotics Computer Surgery

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“…Patients can agree to participate until the day before the operation by signing the informed consent. Other intraoperative complication that has to be speci ed on the case report form (unintended intraoperative damage to major vessels and/or organs requiring reconstruction or resection, intraoperative bleeding requiring urgent transfusion, unexpected medical conditions interrupting or changing the planned procedure [13]).…”

Section: Who Will Take Informed Consentmentioning

confidence: 99%

“…Drain Length of hospital stay is considered from the day of operation until discharge at home or at other facilities, or death. Postoperative complications, including anastomotic and duodenal leak, are classi ed according to the International Consensus on a Complications List After Gastrectomy for Cancer [13] and strati ed by severity using the Clavien-Dindo classi cation [14].…”

Section: Postoperative Proceduresmentioning

confidence: 99%

Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial

Weindelmayer

Mengardo

Veltri

et al. 2020

Preprint

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Background: Prophylactic use of abdominal drain in gastrectomy has been questioned in the last 15 years and a 2015 Cochrane meta-analysis on four RCTs concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless the Authors evidenced the moderate/low quality of the included studies and highlighted how 3 out of four came from Eastern countries. After 2015 only retrospective studies have been published, all with inconsistent results.Methods: ADiGe (Abdominal Drain in GastrEctomy) Trial is a multicenter prospective randomized non-inferiority trial with a parallel design. It aimed to verify whether avoiding routine use of abdominal drain is burdened with complications, particularly an increase in postoperative invasive procedures. Patients with gastric cancer, scheduled for subtotal or total gastrectomy with curative intent, are eligible for inclusion, irrespective of previous oncological treatment. The primary composite endpoint is reoperation or percutaneous drainage procedures within 30 postoperative days. The primary analysis will verify whether the incidence of the primary composite endpoint is higher in the experimental arm, avoiding routine drain placement, than control arm, undergoing prophylactic drain placement, in order to falsify or support the null hypothesis of inferiority. Secondary endpoints assessed for superiority are overall morbidity and mortality, Comprehensive Complications Index, incidence and time for diagnosis of anastomotic and duodenal leaks, length of hospital stay, readmission rate.Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 14.5% in control arm and 9% in the experimental one, 256 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 4.5%. Considering a 15.5% drop-out rate, 304 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomies, recruitment will end at 152 patients for each type of gastrectomy. The surgeon and the patient are blinded until the end of the operation, while postoperative course is not blinded to patient and caregivers.Discussion: ADiGe Trial could contribute to critically re-evaluate the role of prophylactic drain in gastrectomy, a still widely used procedure.Trial registration: Retrospectively registered on 01/10/2020 at Clinicaltrials.gov with the identifier NCT04227951, https://clinicaltrials.gov/ct2/show/NCT04227951.

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“…Others have concentrated on the reporting of outcomes within a defined area. For example, the GASTRODATA group (www.gastrodata.org) have sought to standardise the reporting of all major post-gastrectomy complications 16 . Whilst the goals of both studies are different, both teams have been able to work closely to minimise duplication of work.…”

Section: Collaborationsmentioning

confidence: 99%

Facilitating International Participation in Core Outcome Set Development: A Proposed Approach for Multi-language Delphi Surveys, a Review of Current Practice and Issues to Consider

Alkhaffaf¹,

Williamson²,

Blazeby³

et al. 2020

Preprint

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Background Core outcome sets (COS) should be relevant to key stakeholders and widely applicable so that researchers are willing to use them when designing trials. Many COS developers have utilised online Delphi surveys which enable wider international stakeholder participation. Despite broader participation, most international COS projects have restricted Delphi surveys to a single language potentially excluding important opinion from those who are not fluent in the survey language.Methods A structured review of current approaches to translating Delphi surveys for COS development was undertaken. We present a proposed methodology adapted from international guidance. Results Four studies were identified from our structured review. Wide variation exists in the methodological approaches to translating Delphi surveys for the developing of COS. Issues which arise when developing multi-language Delphi surveys include establishing translation groups, timelines, financial implications, strategies to maximise recruitment and regulatory approvals.Conclusion Consideration of the issues described will improve planning by other COS developers and can be used to widen international participation from both patients and healthcare professionals.

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International consensus on a complications list after gastrectomy for cancer

Cited by 97 publications

References 31 publications

Robotic vs open gastrectomy for gastric cancer: A propensity score‐matched analysis on short‐ and long‐term outcomes

Robotic vs open gastrectomy for gastric cancer: A propensity score‐matched analysis on short‐ and long‐term outcomes

Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial

Facilitating International Participation in Core Outcome Set Development: A Proposed Approach for Multi-language Delphi Surveys, a Review of Current Practice and Issues to Consider

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