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Trial Title:
Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy
NCT ID:
NCT06464978
Condition:
Gastric Cancer
Gastrostomy
Anastomotic Leakage
Postoperative Complications
Conditions: Official terms:
Postoperative Complications
Anastomotic Leak
Conditions: Keywords:
Stapler Reinforcement Patch
Gastrojejunostomy
Randomized Controlled Trial
Surgical Outcomes
Complication Prevention
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Participants will be randomly assigned to either the experimental group receiving the
stapler reinforcement patches or the control group undergoing standard procedures without
reinforcement patches.
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Participants and outcomes assessors will be blinded to the group assignments. Surgeons
will be aware of the group assignments but will not disclose this information to the
participants or the outcomes assessors.
Intervention:
Intervention type:
Device
Intervention name:
Stapler Reinforcement Patch
Description:
Participants in this group will receive gastrojejunostomy with the use of stapler
reinforcement patches.
Arm group label:
Stapler Reinforcement Patch Group
Intervention type:
Device
Intervention name:
Standard Stapler
Description:
Participants in this group will receive gastrojejunostomy with the use of Standard
Stapler
Arm group label:
Standard Stapler Group
Summary:
This is a multi-center, prospective, randomized controlled study aimed at compareing the
impact of stapler reinforcement patches versus standard staplers on postoperative
complications in gastrojejunostomy.
Detailed description:
This study compares stapler reinforcement patches with standard staplers in
gastrojejunostomy to reduce postoperative complications. It aims to demonstrate the
effectiveness and safety of these patches in preventing anastomotic leakage and other
related complications.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age between 18 and 85 years.
- Pathologically diagnosed with gastric cancer and suitable for distal gastrectomy or
subtotal gastrectomy.
- ECOG performance status of 0 or 1.
- ASA (American Society of Anesthesiologists) classification of I-III.
- Voluntary signed informed consent from the participant or their legal
representative.
Exclusion Criteria:
- Evidence of potential distant metastasis found preoperatively.
- History of other malignancies diagnosed within the past 5 years, or any malignancy
treated with chemotherapy or radiotherapy.
- Significant contraindications for surgery (e.g., severe liver or kidney
dysfunction).
- Participation in any other clinical trial within the last 6 months.
- Participants or their legal representatives unwilling to sign the informed consent
or comply with the study protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Yunhong Tian
Address:
City:
Nanchong
Zip:
637000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yunhong Tian, PHD
Phone:
13508087719
Email:
drtianyunhong@126.com
Start date:
May 30, 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Nanchong Central Hospital
Agency class:
Other
Collaborator:
Agency:
Guang'an Central Hospital
Agency class:
Other
Collaborator:
Agency:
Pengan County People's Hospital
Agency class:
Other
Collaborator:
Agency:
Yilong County people's Hospital
Agency class:
Other
Collaborator:
Agency:
Nanbu Hospital of County Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Langzhong People's Hospital
Agency class:
Other
Source:
Nanchong Central Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06464978
