Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-30

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Cancer Gastrostomy Anastomotic Leakage Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Stapler Reinforcement Patch Group

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

Group Type EXPERIMENTAL

Stapler Reinforcement Patch

Intervention Type DEVICE

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

Standard Stapler Group

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

Group Type ACTIVE_COMPARATOR

Standard Stapler

Intervention Type DEVICE

Participants in this group will receive gastrojejunostomy with the use of Standard Stapler

Interventions

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Stapler Reinforcement Patch

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

Intervention Type DEVICE

Standard Stapler

Participants in this group will receive gastrojejunostomy with the use of Standard Stapler

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No