Should we still use prophylactic drain in gastrectomy for cancer? A systematic review and meta-analysis

Weindelmayer, Jacopo; Mengardo, Valentina; Veltri, Alessandro; Torroni, Lorena; Zhao, Enyue; Verlato, Giuseppe; Manzoni, Giovanni De

doi:10.1016/j.ejso.2020.05.009

Cited by 19 publications

(18 citation statements)

References 28 publications

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“…After 2015 other retrospective studies have been published, but most of them included small number of patients and heterogeneous types of surgery, including multi-visceral and R2 resection [5,6,7,8]. Our study group recently published an updated metanalysis including both RCTs and cohort studies comparing the use of prophylactic drain with drain avoidance [9]. The results suggest that skipping drainage can reduce morbidity and length of stay, without affecting other major surgical outcomes.…”

Section: Background and Rationalementioning

confidence: 95%

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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Section: Background and Rationalementioning

confidence: 95%

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

Weindelmayer

Mengardo

Veltri

et al. 2020

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

“…After 2015 other retrospective studies have been published, but most of them included small number of patients and heterogeneous types of surgery, including multi-visceral and R2 resection [5,6,7,8]. Our study group recently published an updated meta-analysis including both RCTs and cohort studies, comparing the use of prophylactic drain with drain avoidance [9]. The results suggest that skipping drainage can reduce morbidity and length of stay, without affecting other major surgical outcomes.…”

Section: Introductionmentioning

confidence: 95%

“…According to a systematic review published in May 2020 [9], the cumulative incidence of reoperation in two RCTs was 7/115=6.1% (95% CI 2.5-12.1%) in the drain group and 3/115=2.6% (95% CI 0.5-7.4%) in the no drain group. Cumulative incidence of additional drain was 1/86=1.2% (95% CI 0.03-6.3%) in the drainage group and 2/84=2.4% (95% CI 0.3-8.3%) in the no drain group.…”

Section: Sample Sizementioning

confidence: 99%

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

Weindelmayer

Mengardo

Veltri

et al. 2021

Preprint

Self Cite

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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 4 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 6.4% in control arm and 4.2% in the experimental one, 364 patients allow to achieve 80% power to detect a non-inferiority margin difference between the arm proportions of 3.6%. Considering a 10% drop-out rate, 404 patients are needed. In order to have a balanced percentage between total and subtotal gastrectomy, recruitment will end at 202 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: Prospectively registered (last updated on October 29, 2020) at Clinicaltrials.gov with the identifier NCT04227951, https://clinicaltrials.gov/ct2/show/NCT04227951.

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“…In addition, early chest drain removal is safe, facilitating movement and recovery post cardiothoracic surgery [ 67 ]. Avoidance of routine prophylactic drain placement in certain procedures can reduce morbidity and length of stay without adversely impacting other surgical outcomes [ 68 ]. Wherever pleural drains are indicated, it is recommended that digital drains are utilized due to their portable nature enabling early mobilization [ 69 ].…”

Section: Components Of Erpsmentioning

confidence: 99%

Framework, component, and implementation of enhanced recovery pathways

2022

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The introduction of enhanced recovery pathways (ERPs) has led to a considerable paradigm shift towards evidence-based, multidisciplinary perioperative care. Such pathways are now widely implemented in a variety of surgical specialties, with largely positive results. In this narrative review, we summarize the principles, components and implementation of ERPs, focusing on recent developments in the field. We also discuss ‘special cases’ in ERPs, including: surgery in frail patients; emergency procedures; and patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19). Supplementary Information The online version contains supplementary material available at 10.1007/s00540-022-03088-x.

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Should we still use prophylactic drain in gastrectomy for cancer? A systematic review and meta-analysis

Cited by 19 publications

References 28 publications

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

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

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

Framework, component, and implementation of enhanced recovery pathways

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