NCT03754907

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

November 25, 2018

Last Update Submit

November 26, 2018

Conditions

Intestinal AtresiaAnastomotic Complication

Keywords

stapled anastomosishand-sewn anastomosisintestinal atresianeonate

Outcome Measures

Primary Outcomes (1)

  • Treatment success rate

    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 Outcomes (8)

  • Operative time(minute)

    1 year

  • Estimated blood loss(ml)

    1 year

  • Time to initial oral feeding

    1 year

  • Time to full oral feeding

    1 year

  • anastomotic leakage and stricture

    1year

  • +3 more secondary outcomes

Other Outcomes (1)

  • classification

    3 year

Study Arms (2)

stapled anastomosis group

EXPERIMENTAL

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.

Procedure: Endocutter stapler

hand-sewn anastomosis group

ACTIVE COMPARATOR

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

Procedure: suture material

Interventions

Endocutter staplerPROCEDURE

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)

stapled anastomosis group
suture materialPROCEDURE

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

hand-sewn anastomosis group

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

RECRUITING

Related Publications (3)

  • Sato K, Uchida H, Tanaka Y, Takazawa S, Jimbo T, Deie K. Stapled intestinal anastomosis is a simple and reliable method for management of intestinal caliber discrepancy in children. Pediatr Surg Int. 2012 Sep;28(9):893-8. doi: 10.1007/s00383-012-3146-y.

    PMID: 22864546BACKGROUND

  • Amano H, Tanaka Y, Tainaka T, Hinoki A, Kawashima H, Kakihara T, Morita K, Uchida H. The impact of body weight on stapled anastomosis in pediatric patients. J Pediatr Surg. 2018 Oct;53(10):2036-2040. doi: 10.1016/j.jpedsurg.2018.04.030. Epub 2018 Apr 26.

    PMID: 29792281BACKGROUND

  • Zheng Z, Jin Z, Gao M, Tang C, Gong Y, Huang L, Liu Y, Wang J. Comparison of Hand-Sewn with Stapled Anastomosis in Neonatal Intestinal Atresia Surgery: A Randomized Controlled Study. J Laparoendosc Adv Surg Tech A. 2022 Jun;32(6):696-701. doi: 10.1089/lap.2021.0714. Epub 2022 Apr 11.

    PMID: 35404135DERIVED

MeSH Terms

Conditions

Intestinal Atresia

Interventions

Sutures

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Yuanmei Liu

    Zunyi Medical College

    STUDY DIRECTOR

Central Study Contacts

zebing zheng, MD

CONTACT

18285269257zebing1988@sina.com

Yuanmei Liu

CONTACT

+868518609329yuanmei116@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
pediatric surgery

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 27, 2018

Study Start

December 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

November 28, 2018

Record last verified: 2018-11

Locations

CN(1)