search
Back to results

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

Primary Purpose

Intestinal Atresia, Anastomotic Complication

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endocutter stapler
suture material
Sponsored by
Zunyi Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Atresia focused on measuring stapled anastomosis, hand-sewn anastomosis, intestinal atresia, neonate

Eligibility Criteria

1 Day - 30 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Affiliated Hospital of Zunyi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

stapled anastomosis group

hand-sewn anastomosis group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
November 25, 2018
Last Updated
November 26, 2018
Sponsor
Zunyi Medical College
search

1. Study Identification

Unique Protocol Identification Number
NCT03754907
Brief Title
Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia
Acronym
SAVSHA
Official Title
Comparing Stapled Anastomosis With Hand-sewn in Neonate With Intestinal Atresia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zunyi Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Atresia, Anastomotic Complication
Keywords
stapled anastomosis, hand-sewn anastomosis, intestinal atresia, neonate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stapled anastomosis group
Arm Type
Experimental
Arm Description
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.
Arm Title
hand-sewn anastomosis group
Arm Type
Active Comparator
Arm Description
Patients chose HA group will performed in an end-to-end manner using absorbable suture material.
Intervention Type
Procedure
Intervention Name(s)
Endocutter stapler
Intervention Description
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
Intervention Name(s)
suture material
Intervention Description
absorbable suture material is used to perform hand-sewn anastomosis in an end-to-end manner.
Primary Outcome Measure Information:
Title
Treatment success rate
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Operative time(minute)
Description
the operative time(minute) in two groups
Time Frame
1 year
Title
Estimated blood loss(ml)
Description
the surgeon estimated blood loss(ml) in two groups
Time Frame
1 year
Title
Time to initial oral feeding
Description
the time patients from operation to the first oral feeding.
Time Frame
1 year
Title
Time to full oral feeding
Description
the time patients from operation to the full oral feeding.
Time Frame
1 year
Title
anastomotic leakage and stricture
Description
the incidence of complications include the anastomotic leakage and stricture between stapled anastomosis and hand-sewn anastomosis.
Time Frame
1year
Title
ileus
Description
the incidence of ileus after operations 1 year in two groups
Time Frame
1 year
Title
volvulus
Description
the incidence of Volvulus with adhesive bands and malrotation because of anastomotic dilatation in two groups after operation 1year
Time Frame
1 year
Title
reoperation
Description
the incidence of complication requiring reoperation
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
classification
Description
counted the classification of intestinal atresia
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zebing zheng, MD
Phone
18285269257
Email
zebing1988@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanmei Liu
Phone
+868518609329
Email
yuanmei116@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanmei Liu
Organizational Affiliation
Zunyi Medical College
Official's Role
Study Director
Facility Information:
Facility Name
Affiliated Hospital of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongruo Liao
Phone
+868518608225
Email
zzbhaofan@sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22864546
Citation
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.
Results Reference
background
PubMed Identifier
29792281
Citation
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.
Results Reference
background
PubMed Identifier
35404135
Citation
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.
Results Reference
derived

Learn more about this trial

Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia

We'll reach out to this number within 24 hrs