Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy

Nanchong Central Hospital

Status: Enrolling

Conditions: Postoperative Complications; Gastric Cancer; Gastrostomy; Anastomotic Leakage

Treatments: Device: Standard Stapler; Device: Stapler Reinforcement Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT06464978

20240530

Details and patient eligibility

About

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.

Full 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.

Enrollment: 382 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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382 participants in 2 patient groups

Stapler Reinforcement Patch Group

Experimental group

Description:

Participants in this group will receive gastrojejunostomy with the use of stapler reinforcement patches.

Treatment:

Device: Stapler Reinforcement Patch

Standard Stapler Group

Active Comparator group

Description:

Participants in this group will receive gastrojejunostomy with the use of standard staplers.

Treatment:

Device: Standard Stapler