Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT07029269
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Enhanced Recovery After Surgery Without Prophylactic Abdominal Drainage Tubes After Laparoscopic Distal Gastrectomy For Gastric Cancer
Sponsor:
Zuoyi Jiao
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: