Actively Recruiting
Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer
Led by Zuoyi Jiao · Updated on 2025-12-17
454
Participants Needed
6
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to compare the effects of using prophylactic abdominal drainage tubes during Enhanced Recovery After Surgery (ERAS) in patients undergoing Laparoscopic Distal Gastrectomy (LDG) for gastric cancer through a multicenter non-inferiority randomized trial. The study is divided into two groups: 1. ERAS-tubeless group: The ERAS protocol without nasogastric decompression, nasojejunal feeding or prophylactic abdominal drainage tubes. 2. ERAS-tube group: the ERAS protocol with prophylactic abdominal drainage tubes, along with no nasogastric decompression or nasojejunal feeding tubes. Patients will be randomly assigned to the two groups in a 1:1 ratio, with the primary analysis based on the modified intention-to-treat population (mITT) and secondary analysis on the per-protocol (PP) population. Perioperative management will adhere to ERAS guidelines, and postoperative quality of life will be assessed using the EORTC QLQ-C30 questionnaire and QoR-15 scores. Preliminary training on the standard ERAS protocol is administered to all members in the team before the initiation of the study, ensuring in-group members to fully master the requirements and other related contents in the study. Data collectors, analysts, and outcome evaluators will remain blinded to group allocation. The findings of this study are expected to provide high-quality evidence on the feasibility of omitting prophylactic abdominal drainage in the context of ERAS, thereby contributing to the optimization of postoperative management strategies for gastric cancer surgery.
CONDITIONS
Official Title
Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years old
- Histopathologically confirmed gastric adenocarcinoma
- Clinical tumor stage of cT1-4N0-3M0
- Undergoing laparoscopic distal gastrectomy
- ECOG performance status score of 0 to 1
- Provided written informed consent
You will not qualify if you...
- Severe concurrent illness or comorbid diseases
- Severe pyloric obstruction, recurrent or remnant gastric cancer
- Perforation or undergoing emergency surgery
- History of radiotherapy
- Undergoing complex abdominal surgeries other than laparoscopic cholecystectomy or appendectomy
- Presence of peritoneal, hepatic, or ovarian metastasis, or simultaneous tumors elsewhere
- Diabetes with poor recent glycemic control
- Autoimmune diseases treated with corticosteroids
- Body mass index of 30 kg/m2 or more, or less than 18 kg/m2
- Gastrointestinal hemorrhage with hemoglobin below 90 g/L
- Hypoproteinemia with albumin below 30 g/L
- Portal hypertension
- Severe edema or dense fibrosis found during surgery after neoadjuvant therapy
- Intraoperative findings of duodenal invasion
- Combined organ resection
- Reconstruction different from Billroth I and Braun anastomosis
- Preoperative pathology inconsistent with postoperative results
- Declined to participate
- Poor compliance or withdrew from the study midway
AI-Screening
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Trial Site Locations
Total: 6 locations
1
International Hospital of Pecking University
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
2
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
3
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
4
Sun Yat-sen University Cancer Center Gansu Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
5
Zhejiang Cancer Hospital
Zhejiang, Hangzhou, China, 310005
Actively Recruiting
6
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Xi'an City, China, 710061
Actively Recruiting
Research Team
Z
Zuoyi Jiao, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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