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Stapler Reinforcement Patches Compared to Standard Staplers in Gastrojejunostomy

Recruiting
18 - 85 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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.

Study details

Gastric Cancer, Gastrostomy, Anastomotic Leakage, Postoperative Complications

NCT06464978

Nanchong Central Hospital

22 June 2024

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