Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intestinal Atresia Anastomotic Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Endocutter stapler

Intervention Type PROCEDURE

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)

hand-sewn anastomosis group

Patients chose HA group will performed in an end-to-end manner using absorbable suture material.

Group Type ACTIVE_COMPARATOR

suture material

Intervention Type PROCEDURE

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

Interventions

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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)

Intervention Type PROCEDURE

suture material

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No