N/A
N=60
Perianastomotic Drain After Gastrectomy (DRAG)
Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04288661 ↗Enrolled (actual)
60
Serious AEs
1.7%
Results posted
Apr 2025
Primary outcome: Primary: a) Number of Participants With High Pain Levels (Using the Visual Analog Scale) — 31; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- No drain placement (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- THEODOROU DIMITRIOS
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY a) Number of Participants With High Pain Levels (Using the Visual Analog Scale) |
31; 3 | — |
| PRIMARY Number of Participant Who Exhibited Postoperative Nausea and Vomiting (PONV) Within the First 5 Days |
24; 5 | — |
| PRIMARY Number of Participants With Delay of Feeding Initiation |
15; 2 | — |
| PRIMARY Number of Participants With Delay of Postoperative Mobilization |
20; 2 | — |
| PRIMARY Length of Hospital Stay |
7; 5 | — |
| PRIMARY Day of Postoperative Bowel Mobilization |
4; 3 | — |
| SECONDARY Mortality |
1; 2 | — |
| SECONDARY Surgically Related Readmissions |
5; 0 | — |
| SECONDARY Reoperations |
4; 2 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT04288661). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.