Intra-Operative Abdominal Drain Placement for Gallbladder Cancer Surgery and Risk of Infectious Complications

The purpose of this study was to investigate the role of intra-abdominal closed-suction drainage after emergent trauma laparotomy for isolated solid organ injuries (iSOI) and to determine its association with deep surgical site infections (DSSI). All patients subjected to trauma laparotomy between January 2006 and December 2008 for an iSOI at two Level I urban trauma centers were identified. Patients with isolated hepatic, splenic, or renal injuries were included. Study variables extracted included demographics, clinical characteristics, intra-abdominal injuries, drain placement, DSSI, septic events, intensive care unit and hospital length of stay, and in-hospital mortality. Diagnosis of DSSI was based on abdominal computed tomography scan demonstrating an intra-abdominal collection combined with fever and elevated white blood cell count. For the analysis, patients were stratified based on injury severity. To identify an independent association between closed-suction drain placement and DSSI, stepwise logistic regression analysis was performed. Overall, 142 patients met the inclusion criteria with 80 per cent (n = 114) having severe iSOI. In 47 per cent (n = 53) of the patients with a severe injury, an intra-abdominal drain was placed. A drain was placed more often in patients with a blunt trauma with more severe injury defined by Injury Severity Score and abdominal Abbreviated Injury Scale Score and those who underwent splenectomy ( P < 0.05). There was a three-fold increased risk of DSSI in patients subjected to drain placement (odds ratio, 2.8; 95% confidence interval, 1.0 to 8.2; P = 0.046). Subgroup analysis demonstrated those who sustained severe hepatic injury receiving a drain had a significantly increase risk of DSSI ( P = 0.02). There was no statistical difference in the rate of DSSI based on the presence or absence of an intra-abdominal drain after severe splenic injury (17 vs 18%, P = 0.88). The use of intra-abdominal closed-suction drains after iSOI is not associated with decreased risk of DSSI.

Download Full-text

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

Trials ◽

10.1186/s13063-021-05102-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

J. Weindelmayer ◽

◽

V. Mengardo ◽

A. Veltri ◽

G. L. Baiocchi ◽

...

Keyword(s):

Subtotal Gastrectomy ◽

Composite Endpoint ◽

Convincing Evidence ◽

Drop Out ◽

Primary Analysis ◽

Curative Intent ◽

Oncological Treatment ◽

Abdominal Drain ◽

Primary Composite Endpoint ◽

Drain Placement

Abstract 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, and readmission rate. Assuming one-sided alpha of 5%, and cumulative incidence of the primary composite endpoint of 6.4% in the 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 the 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 29 October 2020) at ClinicalTrials.gov with the identifier NCT04227951.

Download Full-text