The Drain Debate: Reevaluating Prophylactic Drains in Total Gastrectomy- A Controlled Trial on the Use of Prophylactic Drains in Total Gastrectomy for Gastric Cancer
Phase: NA
Conditions: Gastric Cancer
Sponsor: THEODOROU DIMITRIOS

The Drain Debate: Reevaluating Prophylactic Drains in Total Gastrectomy- A 
Controlled Trial on the Use of Prophylactic Drains in Total Gastrectomy for 
Gastric Cancer (DRAG Study) 
 
 
 
 
Trial registration: Clinical Trials.gov NCT 04288661 
 
 
 
 
 
Upload date: 01/02/2021 

STUDY PROTOCOL 
 
 
The DRAG (DRains After Gastrectomy) Trial is a prospective, non- 
randomized, controlled clinical trial involving patients diagnosed with gastric 
neoplasm. All surgeries were performed by a single, highly experienced surgeon in the 
1st Propaedeutic Surgery Department at Hippocration General Hospital in Athens, 
Greece. The patients underwent open total gastrectomy with D2 lymph node dissection, 
followed by Roux-en-Y gastrointestinal tract reconstruction, in accordance with a 
predefined, ERAS-compliant perioperative departmental protocol. Our institution’s 
protocol does not routinely incorporate exploratory laparoscopy or peritoneal cytology. 
 
The participants were divided into two groups. The first group followed the 
department's standard practice, with a drain placed near the esophagojejunal 
anastomosis (drain group). In contrast, the second did not have a drain placed (non- 
drain group). The decision to place a drain was based on the following criteria: 
 
a) Pulmonary diseases under oxygen therapy 
 
b) Chronic oral steroid use (≥5mg/day prednisone equivalent for >1month) 
 
c) Intraoperative hemodynamic instability requiring vasopressors 
 
d) Intraoperative blood loss exceeding 250 mL 
 
e) Vessel injury (celiac axis or its branches) 
 
f) Injury to adjacent structures (pancreas, spleen, duodenum) 
g) Tension of the anastomosis 
h) Uncertainty regarding duodenal stump integrity due to either staple misfire 
or tissue quality issues 

Per our departmental protocol, patients were gradually mobilized starting directly 
after surgery, when feasible. On the second postoperative day, an oral gastrografin 
study was conducted for each patient to detect any early anastomotic leaks. Following 
a normal radiological study, patients were initiated on a liquid diet, which was then 
advanced to pureed food on the third postoperative day, and a soft diet on the fourth 
day. For patients in the drain group, the drain was removed on the fifth postoperative 
day, provided that the drainage volume was less than 50 mL over the preceding 48 
hours, in line with departmental protocol. A descriptive timeline of the protocol is 
presented in the the table below. 

a) Appendix 1. Timeline of study protocol 
 
STUDY PERIOD 
ENROLLMENT 
DAYS 
DAY OF 
SURGERY 
POSTOPERATIVE DAYS 
TIMEPOINT 
-7 TO -2 
-1 
0 
1 
2 
3 
4 
5 
Ω 
ENROLLMENT 
PATIENT SELECTION 
X 
PREOP CHECK 
X 
CONSENT SIGN 
X 
PROTOCOL EDUCATION 
X 
INTERVENTION 
DRAIN PLACEMENT 
X 
INTRAOPERATIVE DATA 
RECORDING 
X 
MONITORING 
CLIN. EXAMINATION &VITALS 
X 
X 
X 
X 
X 
X 
LABS 
X 
X 
X 
X 
X 
X 
DRAIN CONTENT 
MONITORING 
X 
X 
X 
X 
X 
X 
X 
ORAL CONTRAST STUDY 
X 
PONV 
X 
X 
X 
X 
X 
PAIN (VAS SCORE) 
X 
X 
X 
X 
X 
X 
SSI 
X 
X 
X 
X 
X 
MOBILIZATION 
X 
X 
X 
X 
X 
ORAL FEEDING 
X 
X 
X 
X 
X 
GUT MOTILITY 
X 
X 
X 
X 
X 
X 
EXTRAABDOMINAL 
COMPLICATIONS 
X 
X 
X 
X 
X 
LOS 
X 
X 
X 
X 
X 
X 
MORTALITY 
X 
X 
X 
X 
X 
X 
READMISSIONS 
X 
X 
X 
X 
X 
X 
REOPERATIONS 
b) 
LOS: length of stay, SSI: surgical site infection, VAS score: visual analogue score 
c) Ω: time between POD#5 and discharge 

This study was conducted in accordance with the principles outlined in the 
Helsinki Declaration of Human Rights and with the Guidelines of Good Clinical 
Practice. The final study protocol and the informed consent form for participant 
inclusion received approval from the Institutional Review Board (IRB). The IRB 
also conducted regular assessments, as required, to ensure the ongoing compliance 
with lawful medical practice throughout the trial. 
 
The statistical analysis was performed using the R software (R foundation for 
Statistical Computing) version 4.3.0 for Windows. Descriptive characteristics for the 
quantitative data were expressed as median and Quartile 1 (Q1) to Quartile 3 (Q3) range 
and for completeness reasons the mean ± standard deviation (SD), for the qualitative 
data was reported the frequency of occurrence and the relevant percentage. 
Comparisons were preformed between patients with drainage and those without 
drainage; for the qualitative parameters statistical tests were performed via the chi- 
square test (and if required a Fisher exact test) and for the arithmetic data (as normality 
was not possible to be ensured using the Shapiro Wilk test), were applied not parametric 
tests, specifically the Mann Whitney U test. The significance level (p-value) was set to 
0.05, thus statistically significant difference between compared groups was for p<0.05 
and all tests were two sided.