CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
No drain placementprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04288661
NCT04288661N/ACompleted

The Drain Debate: Reevaluating Prophylactic Drains in Total Gastrectomy- A Controlled Trial on the Use of Prophylactic Drains in Total Gastrectomy for Gastric Cancer

THEODOROU DIMITRIOS·interventional·Posted Feb 28, 2020·Updated Apr 27, 2025

In Brief

A clinical study evaluating No drain placement for Gastric Cancer. Completed, enrolled 60 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer
CountriesGreece
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 28, 2020
Enrollment StartFeb 28, 2020
Primary CompletionFeb 28, 2023
Study CompletionJun 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 6.3 years ago

Interventions

No drain placementprocedure

The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered, according to the criteria stated above