Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia

Last updated: November 26, 2018
Sponsor: Zunyi Medical College
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ileus

Treatment

N/A

Clinical Study ID

NCT03754907
Zunyi Medical University
  • Ages < 30
  • All Genders

Study Summary

Neonatal intestinal atresia is the most difficult disease to apply stapled anastomosis. However, there are no high-quality clinical trial to verify its effectiveness. Therefore, the investigators compared the outcomes of stapled and hand-sewn anastomosis in neonate with intestinal atresia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients were eligible if they were between 1 day and 30 days of age, and if theysuffered from intestinal atresia.

Exclusion

Exclusion Criteria:

  • These patients were complicated with intestinal perforation and peritonitis,instability of vital signs.

  • Stapled anastomosis could not be performed when the intestinal lumen could not admit a 22-Fr soft catheter.

Study Design

Total Participants: 40
Study Start date:
December 01, 2018
Estimated Completion Date:
December 01, 2021

Study Description

Intestinal anastomosis in neonates with intestinal atresia has traditionally been performed using the hand-sewn end-to-end approach. After the introduction of stapled functional end-to-end anastomosis (FEEA) in neonates and infants by Powell in 1995, the procedure is gradually being accepted among pediatric surgeons. When treating intestinal atresia, great discrepancy between diameters of the proximal and distal intestine caused by disuse atrophy are often observed, which may cause difficulties and complications. To overcome size discrepancy, proficiency in performing anastomosis is required when using hand-sewn techniques. in theory, stapled functional end-to-end anastomosis does not require a special technique and does not impair the passage of intestinal contents immediately after completion because the side-to-side nature of the procedure retains the unique diameter of the target intestine and preserves patency. Stapled side-to-side functional end-to-end intestinal anastomosis is a potentially useful technique that is not affected by intestinal size discrepancy and does not require specialized surgical experience.To date, there have been a few studies about the safety and efficacy of stapled anastomosis in neonates and infants, which reported the efficacy of stapled over hand-sewn anastomosis, including shorter operative time, time to full feeding and hospitalization, and no difference in adverse outcomes between both types of anastomoses. These studies compared the clinical outcomes in neonates and infants. However,there are no high-quality clinical trials to verify its effectiveness. Therefore, the investigators compared the outcomes of stapled FEEA and hand-sewn anastomosis in neonate with intestinal atresia.

Connect with a study center

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou 563000
    China

    Active - Recruiting

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