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Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia

NCT03754907 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-11-28

No results posted yet for this 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.

Conditions

  • Intestinal Atresia
  • Anastomotic Complication

Interventions

PROCEDURE

Endocutter stapler

Endocutter ETS 35, ETS Flex 45 stapler, and the Echelon Flex Powered ENDOPATH Stapler with 2.5- or 3.5-mm staples (Johnson \& Johnson K.K., Tokyo, Japan)

PROCEDURE

suture material

absorbable suture material is used to perform hand-sewn anastomosis in an end-to-end manner.

Sponsors & Collaborators

  • Zunyi Medical College

    lead OTHER

Principal Investigators

  • Yuanmei Liu · Zunyi Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-12-01
Completion
2021-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03754907 on ClinicalTrials.gov