Perianastomotic Drain After Gastrectomy (DRAG)

NCT04288661 | Completed Results DMC

• 1 other identifier: 1678 / 31-01-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer

Keywords

prophylactic drain; total gastrectomy; gastric cancer; esophagogastric anastomosis leak; drain criteria

Outcome Measures

Primary Outcomes (6)

• a) Number of Participants With High Pain Levels (Using the Visual Analog Scale)

  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.

  Hospital stay, an average of 5 days

• Number of Participant Who Exhibited Postoperative Nausea and Vomiting (PONV) Within the First 5 Days

  Postoperative nausea and vomiting (PONV) is considered an immediate effect of the perianastomotic drain. Measured as present or absent, with presence meaning worse results

  Hospital stay, an average of 5 days

• Number of Participants With Delay of Feeding Initiation

  immediate outcome of perianastomic drain placement. Feeding is considered delayed if started after the 3rd day as per our protocol

  Hospital stay, an average of 5 days

• Number of Participants With Delay of Postoperative Mobilization

  immediate postoperative effect of drain placement. Mobilization is considered delayed if the patient does not manage to achieve the milestones as per our(and ERAS)protocol.

  Hospital stay, an average of 5 days

• Length of Hospital Stay

  immediate effect of drain placement

  Hospital stay, an average of 5 days

• Day of Postoperative Bowel Mobilization

  immediate effect of drain placement. If there is no mobilization of bowel (flatus or motion) within the first 3 days, it is considered delay of the bowel movement

  Hospital stay approx 5 days

Secondary Outcomes (3)

• Mortality

  30 days

• Surgically Related Readmissions

  30 days

• Reoperations

  30 days

Study Arms (2)

Drain

NO INTERVENTION

The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice

No drain

EXPERIMENTAL

The patients of this arm do not undergo perianastomotic drain placement.

Procedure: No drain placement

Interventions

No drain placement PROCEDURE

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

No drain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• THEODOROU DIMITRIOS: lead

Study Sites (1)

Hippocration General Hospital

Athens, 11527, Greece

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Results Point of Contact

• Title: Dr Maria Malvina Eleftheriou
• Organization: 1st Propaedeutic Surgery Department,Hippocration Hospital,University of Athens, Greece

malvina_el@hotmail.com

+30 6945176503

Study Officials

• Dimitrios Theodorou, Professor

  University of Athens

  STUDY CHAIR

• Maria-Malvina Eleftheriou, MD

  Hippocration General Hospital of Athens

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: February 23, 2020
• First Posted: February 28, 2020
• Study Start: February 28, 2020
• Primary Completion: February 28, 2023
• Study Completion: June 30, 2024
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)