RecruitingPhase 3NCT07029269

Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer

Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer: A Prospective, Multicenter, Non-inferiority, Randomized, Open-label, Controlled Trial


Sponsor

Zuoyi Jiao

Enrollment

454 participants

Start Date

Jun 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether it is safe to skip the routine use of abdominal drainage tubes after minimally invasive stomach surgery for gastric cancer, as part of an enhanced recovery program. **You may be eligible if:** - You are between 18 and 80 years old - You have stomach (gastric) cancer confirmed by biopsy - You are scheduled for a laparoscopic (keyhole) partial stomach removal - You are in good physical health (able to carry out daily activities) **You may NOT be eligible if:** - You have a serious other illness that complicates recovery - Your cancer has blocked or perforated the stomach, or requires emergency surgery - You have had prior radiation therapy to the area - Your cancer has spread to the liver, ovaries, or the lining of the abdomen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREERAS-tubeless group

Nasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; No abdominal drainage and nasojejunal feeding tubes were placed intraoperatively; None of these 3 tubes were present postoperatively.

PROCEDUREERAS-tube group

Nasogastric decompression tube is not placed preoperatively; If necessary, nasogastric decompression tube is placed after anesthesia induction during surgery and removed when the reconstruction is performed; Nasojejunal feeding tube is not placed intraoperatively; 1 prophylactic abdominal drainage tube is placed at the duodenal stump for LDG and retained postoperatively.


Locations(6)

International Hospital of Pecking University

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Sun Yat-sen University Cancer Center Gansu Hospital

Lanzhou, Gansu, China

Zhejiang Cancer Hospital

Zhejiang, Hangzhou, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Xi'an City, China

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NCT07029269


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