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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| hand-sewn anastomosis group | Active Comparator | Patients chose HA group will performed in an end-to-end manner using absorbable suture material. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocutter stapler | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time(minute) | the operative time(minute) in two groups | 1 year |
| Estimated blood loss(ml) | the surgeon estimated blood loss(ml) in two groups |
| Measure | Description | Time Frame |
|---|---|---|
| classification | counted the classification of intestinal atresia | 3 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zebing zheng, MD | Contact | 18285269257 | zebing1988@sina.com | |
| Yuanmei Liu | Contact | +868518609329 | yuanmei116@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuanmei Liu | Zunyi Medical College | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Zunyi Medical University | Recruiting | Zunyi | Guizhou | 563000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22864546 | Background | 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. | |
| 29792281 | Background | 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. |
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| ID | Term |
|---|---|
| D007409 | Intestinal Atresia |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| suture material | Procedure | absorbable suture material is used to perform hand-sewn anastomosis in an end-to-end manner. |
|
| 1 year |
| Time to initial oral feeding | the time patients from operation to the first oral feeding. | 1 year |
| Time to full oral feeding | the time patients from operation to the full oral feeding. | 1 year |
| anastomotic leakage and stricture | the incidence of complications include the anastomotic leakage and stricture between stapled anastomosis and hand-sewn anastomosis. | 1year |
| ileus | the incidence of ileus after operations 1 year in two groups | 1 year |
| volvulus | the incidence of Volvulus with adhesive bands and malrotation because of anastomotic dilatation in two groups after operation 1year | 1 year |
| reoperation | the incidence of complication requiring reoperation | 1 year |
| 35404135 | Derived | 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. |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |