Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia (SAVSHA)

November 26, 2018 updated by: zebing Zheng, Zunyi Medical College

Comparing Stapled Anastomosis With Hand-sewn in Neonate With Intestinal Atresia

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stapled anastomosis group
Following the first side-to-side anastomosis at the antimesenteric border in both intestinal limbs, the staple lines are oversewn to reinforce the crotch. Thereafter, the stapler is again fired across the joined intestinal limbs to close the enterotomies. The suture line of the side-to-side anastomosis should not overlap, and the staple lines are oversewn to reinforce the double-stapled areas.
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)
Active Comparator: hand-sewn anastomosis group
Patients chose HA group will performed in an end-to-end manner using absorbable suture material.
absorbable suture material is used to perform hand-sewn anastomosis in an end-to-end manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success rate
Time Frame: 1 year
Treatment success rate is defined as a patient successfully undergoing two respectively operative methods in two groups , resulting in discharge from the hospital without the need for reoperation intervention and no complication happened during a minimum follow-up of 1 year (treatment efficacy).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time(minute)
Time Frame: 1 year
the operative time(minute) in two groups
1 year
Estimated blood loss(ml)
Time Frame: 1 year
the surgeon estimated blood loss(ml) in two groups
1 year
Time to initial oral feeding
Time Frame: 1 year
the time patients from operation to the first oral feeding.
1 year
Time to full oral feeding
Time Frame: 1 year
the time patients from operation to the full oral feeding.
1 year
anastomotic leakage and stricture
Time Frame: 1year
the incidence of complications include the anastomotic leakage and stricture between stapled anastomosis and hand-sewn anastomosis.
1year
ileus
Time Frame: 1 year
the incidence of ileus after operations 1 year in two groups
1 year
volvulus
Time Frame: 1 year
the incidence of Volvulus with adhesive bands and malrotation because of anastomotic dilatation in two groups after operation 1year
1 year
reoperation
Time Frame: 1 year
the incidence of complication requiring reoperation
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
classification
Time Frame: 3 year
counted the classification of intestinal atresia
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Yuanmei Liu, Zunyi Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

November 25, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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