Clinical trial NCT04288661: Perianastomotic Drain After Gastrectomy (DRAG)
Official title: The Drain Debate: Reevaluating Prophylactic Drains in Total Gastrectomy- A Controlled Trial on the Use of Prophylactic Drains in Total Gastrectomy for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: prophylactic drain
total gastrectomy
gastric cancer
esophagogastric anastomosis leak
drain criteria
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastric cancer ranks as the fifth most common and fifth most lethal cancer globally. For patients with AJCC stages IB to IIIC, representing the majority of cases, the current gold standard of surgical treatment involves total gastrectomy combined with D2 lymph node dissection, followed by gastrointestinal tract reconstruction .It has long been established that minimizing surgical intervention correlates with faster patient recovery. The Enhanced Recovery After Surgery (ERAS) guidelines provide globally recognized perioperative recommendations for a variety of surgical procedures, grounded in research, audits, and evidence-based practice. In 2014, Mortensen et al. introduced ERAS guidelines specifically tailored for gastrectomy in gastric cancer. These guidelines include both procedure-specific and general recommendations applicable to the perioperative management of abdominal surgeries.Since the publication of ERAS guidelines, evidence suggests limited and inconsistent global adherence to the protocol for gastrectomy, particularly regarding surgical drain use.Drains remain in use for gastrectomy, particularly in the East, where ongoing studies explore the prognostic value of drain contents post-gastrectomy without reaching consensus. Western adherence to ERAS recommendations on drains is similarly low.This prospective, non-randomized controlled clinical trial aims to assess the impact of one perianastomotic drain when it is placed under specific, predefined criteria. The trial evaluates the immediate and short-term postoperative outcomes in patients who underwent D2 total gastrectomy for gastric cancer which were performed in a high-volume centre and under the care of a highly experienced team

Detailed description: 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:

1. Pulmonary diseases under oxygen therapy
2. Chronic oral steroid use (≥5mg/day prednisone equivalent for \>1month)
3. Intraoperative hemodynamic instability requiring vasopressors
4. Intraoperative blood loss exceeding 250 mL
5. Vessel injury (celiac axis or its branches)
6. Injury to adjacent structures (pancreas, spleen, duodenum)
7. Tension of the anastomosis
8. 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 The primary outcomes measured in this study were: a) pain levels, assessed using the Visual Analog Scale (VAS) during the first 5 postoperative days, b) postoperative nausea and vomiting (PONV) within the first 5 days, c) initiation of feeding, d) postoperative bowel mobilization, e) patient mobilization, f) length of hospital stay (LOS) Secondary outcomes included: a) mortality, b) surgically related readmissions and c) reoperations 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.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Histologically proven EGJ (Siewert II or III) or non-EGJ gastric adenocarcinoma (intestinal, diffuse, or mixed Lauren type)
* Surgical candidates for total gastrectomy plus D2 lymph node dissection
* ECOG performance status 0 or 1
* Signed informed consent from
* Preoperative evaluation of cTanyNanyM0 according to the American Joint Committee on Cancer Staging Manual, 7th edition

Exclusion Criteria:

* M1 disease
* Other unplanned organ excision
* Massive ascites or cachexia
* Current participation in any other clinical trial
* Severe cardiovascular, respiratory tract, kidney, liver, or psychiatric disease.
* Poor compliance to the clinical protocol
* Pregnancy

Primary outcomes:
measure: a) Number of Participants With High Pain Levels (Using the Visual Analog Scale)
timeFrame: Hospital stay, an average of 5 days
measure: Number of Participant Who Exhibited Postoperative Nausea and Vomiting (PONV) Within the First 5 Days
timeFrame: Hospital stay, an average of 5 days
measure: Number of Participants With Delay of Feeding Initiation
timeFrame: Hospital stay, an average of 5 days
measure: Number of Participants With Delay of Postoperative Mobilization
timeFrame: Hospital stay, an average of 5 days
measure: Length of Hospital Stay
timeFrame: Hospital stay, an average of 5 days
measure: Day of Postoperative Bowel Mobilization
timeFrame: Hospital stay approx 5 days
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Surgically Related Readmissions
timeFrame: 30 days
measure: Reoperations
timeFrame: 30 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hippocration General Hospital
Study officials:
affiliation: University of Athens
name: Dimitrios Theodorou, Professor
role: STUDY_CHAIR
affiliation: Hippocration General Hospital of Athens
name: Maria-Malvina Eleftheriou, MD
role: PRINCIPAL_INVESTIGATOR
References: