Perianastomotic Drain After Gastrectomy (DRAG) (DRAG)

Assessment of Abdominal Perianastomotic Drain Placement After Open Gastrectomy for Gastric Cancer

The placement of an abdominal drain consists one of the most controversial issues not only after gastrectomy, but also after any abdominal operation in general. During the past decades drains have been widely used after major abdominal operations. Nevertheless, following the latest perioperative management trends, not all surgeons seem to embrace the idea. There are still many new studies or in progress, mainly in the East, examining the prognostic value of the drain content after a gastrectomy. Thus, the use of a drain is still under question. The aim of the present study is to evaluate whether the placement of a perianastomotic drain after total gastrectomy with D2 lymphadenectomy contributes to the early diagnosis of intraabdominal complications such as bleeding, abscess, anastomotic leak or pancreatic fistula. The participants will be patients with pathologically confirmed gastric or gastroesophageal junction (GEJ) cancer, and will undergo total gastrectomy plus D2 lymph node dissection and Roux-en-Y gastrointestinal tract reconstruction.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: No drain placement

Detailed Description

This is a prospective randomized controlled trial that will be conducted in the 1st Propaedeutic Department of Surgery of National and Kapodistrian University of Athens. Sixty six patients suffering from histologically confirmed gastric or gastroesophageal junction cancer will be included in the study. They will be treated with a typical total gastrectomy plus D2 lymph node dissection and Roux-en-Y gastrointestinal tract reconstruction, under a predefined perioperative protocol, which complies with the ERAS guidelines. All patients will have to sign a study specific consent form and will be educated to the perioperative protocol prior to the operation. The randomization will take place right before the abdominal wall closure, and the participants will be divided in two groups: the intervention group (without perianastomotic drain) and the control group (placement of a suction drain close to the esophagojejunal anastomosis). In the control group, the drain will be removed as usual on the fifth postoperative day only if the below criteria are satisfied: a)less than 100cc of drainage for two consecutive days and b) no clinical suspicion of anastomotic leak and/or bleeding and/or intraabdominal abscess and/or pancreatic fistula. The participants' preoperative and intraoperative data will be meticulously recorded. The postoperative course of all patients will be closely monitored and any clinical, laboratory or imaging suspicion of the above mentioned complications will be evaluated and managed as per institutional standard of care. The subjects will be followed up on postoperative days ten, thirty and sixty through clinical examination, laboratory tests and, if needed, imaging exams. The primary outcome of this trial will be the postoperative day on which a Clavien-Dindo II-IV complication will be detected. The secondary outcome measures will include length of stay, morbidity and mortality, drain- related morbidity, postoperative pain evaluation, quality of life after the operation and readmissions.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria-Malvina Eleftheriou, MD; Phone Number: 2132088142; Email: malvina_el@hotmail.com

Study Locations

• Greece
  • Athens, Greece, 11527
    • Recruiting
    • Hippocration General Hospital
    • Contact: Maria- Malvina Eleftheriou, MD; Phone Number: 2132088142; Email: malvina_el@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age more than or equal to 18 years
• Histologically proven gastric or gastro-esophageal cancer
• Patients that undergo open total D2 gastrectomy with Roux-en-Y reconstruction
• ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1
• Curative resection
• Signed informed consent form

Exclusion Criteria:

• Metastatic disease
• Additional resections needed
• Ascites
• Cachexia
• Concurrent participation in other study(ies)
• Concurrent diagnosis of mental illness
• Lack of perioperative protocol compliance
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Drain; The patients of this arm undergo perianastomotic drain placement, as per standard of care institutional practice
Experimental: No drain; The patients of this arm do not undergo perianastomotic drain placement.	Procedure: No drain placement; The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POD of intra-abdominal complication detection	Post-operative day of class II-IV intra-abdominal complication detection	Hospital stay, an average of 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stay	Hospital stay (in days)	Hospital stay, an average of 7 days
Mortality	Mortality	60 post-operative days
Morbidity	Total Morbidity	60 post-operative days
Drain related morbidity	Drain related morbidity	60 post-operative days
Post-operative pain: visual analogue scale (VAS) score	Post-operative pain assessment with visual analogue scale (VAS) score	60 post-operative days
Quality of life before and after gastrectomy: questionnaire assessment	Quality of life questionnaire assessment	60 post-operative days
Readmissions	Readmission rate	60 post-operative days

Collaborators and Investigators

• Sponsor: THEODOROU DIMITRIOS
• Investigators: Study Chair: Dimitrios Theodorou, Professor, University of Athens; Principal Investigator: Maria-Malvina Eleftheriou, MD, Hippocration General Hospital of Athens

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: gastrectomy; perianastomotic drain; complication detection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: 1678 / 31-01-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No