Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia

Anastomotic Complication Clinical Trial

— SAVSHA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03754907
• Other study ID #: Zunyi Medical University
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2018
• Source: Zunyi Medical College
• Contact: zebing zheng, MD
• Phone: 18285269257
• Email: zebing1988[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Complication
• Intestinal Atresia

Intervention

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

Locations

Country	Name	City	State
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Zunyi Medical College

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	classification	counted the classification of intestinal atresia	3 year
Primary	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	Operative time(minute)	the operative time(minute) in two groups	1 year
Secondary	Estimated blood loss(ml)	the surgeon estimated blood loss(ml) in two groups	1 year
Secondary	Time to initial oral feeding	the time patients from operation to the first oral feeding.	1 year
Secondary	Time to full oral feeding	the time patients from operation to the full oral feeding.	1 year
Secondary	anastomotic leakage and stricture	the incidence of complications include the anastomotic leakage and stricture between stapled anastomosis and hand-sewn anastomosis.	1year
Secondary	ileus	the incidence of ileus after operations 1 year in two groups	1 year
Secondary	volvulus	the incidence of Volvulus with adhesive bands and malrotation because of anastomotic dilatation in two groups after operation 1year	1 year
Secondary	reoperation	the incidence of complication requiring reoperation	1 year