Clinical trial NCT03754907: Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia
Official title: Comparing Stapled Anastomosis With Hand-sewn in Neonate With Intestinal Atresia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intestinal Atresia
Anastomotic Complication
Keywords: stapled anastomosis
hand-sewn anastomosis
intestinal atresia
neonate
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment success rate
timeFrame: 1 year
Secondary outcomes:
measure: Operative time(minute)
timeFrame: 1 year
measure: Estimated blood loss(ml)
timeFrame: 1 year
measure: Time to initial oral feeding
timeFrame: 1 year
measure: Time to full oral feeding
timeFrame: 1 year
measure: anastomotic leakage and stricture
timeFrame: 1year
measure: ileus
timeFrame: 1 year
measure: volvulus
timeFrame: 1 year
measure: reoperation
timeFrame: 1 year
Other outcomes:
measure: classification
timeFrame: 3 year
Locations:
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
Study officials:
affiliation: Zunyi Medical College
name: Yuanmei Liu
role: STUDY_DIRECTOR
References:
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.
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.
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.