Comparing Stapled Anastomosis With Hand-sewn in Neonate With Intestinal Atresia
| Registry | NCT03754907, acronym SAVSHA |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | Zunyi Medical College (Other) |
| Conditions | Intestinal Atresia, Anastomotic Complication |
| Interventions | Endocutter stapler, suture material (Procedure) |
| Dates | start 2018-12-01 (estimated), primary completion 2020-12-01 (estimated), completion 2021-12-01 (estimated), first posted 2018-11-27, last updated 2018-11-28 |
| Locations | 1 site in China |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| stapled anastomosis group | Experimental | Procedure: Endocutter stapler | 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 | Procedure: suture material | Patients chose HA group will performed in an end-to-end manner using absorbable suture material. |
Sex: All, ages: 1 Day to 30 Days
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Affiliated Hospital of Zunyi Medical University | Zunyi, Guizhou | China | Recruiting |