Clinical trial · Interventional
Perianastomotic Drain After Gastrectomy (DRAG)
The Drain Debate: Reevaluating Prophylactic Drains in Total Gastrectomy- A Controlled Trial on the Use of Prophylactic Drains in Total Gastrectomy for Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No drain placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Drain
- description
- The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
- type
- EXPERIMENTAL
- label
- No drain
- description
- The patients of this arm do not undergo perianastomotic drain placement.
- interventionNames
- Procedure: No drain placement
Primary outcomes (6)
- measure
- a) Number of Participants With High Pain Levels (Using the Visual Analog Scale)
- timeFrame
- Hospital stay, an average of 5 days
- description
- Postoperative pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). VAS scores will be recorded during the patient's hospital stay following total gastrectomy. For analysis, pain intensity will be categorized into two groups: High pain: VAS score greater than 5 Not high pain: VAS score 5 or less This binary classification will be used to compare postoperative pain outcomes between patients with and without anastomotic drain placement, helping to evaluate whether drain usage is associated with increased postoperative pain.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available