- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03754907
Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia (SAVSHA)
November 26, 2018 updated by: zebing Zheng, Zunyi Medical College
Comparing Stapled Anastomosis With Hand-sewn in Neonate With Intestinal Atresia
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: zebing zheng, MD
- Phone Number: 18285269257
- Email: zebing1988@sina.com
Study Contact Backup
- Name: Yuanmei Liu
- Phone Number: +868518609329
- Email: yuanmei116@aliyun.com
Study Locations
-
-
Guizhou
-
Zunyi, Guizhou, China, 563000
- Recruiting
- Affiliated Hospital of Zunyi Medical University
-
Contact:
- Rongruo Liao
- Phone Number: +868518608225
- Email: zzbhaofan@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 4 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: stapled anastomosis group
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.
|
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)
|
Active Comparator: hand-sewn anastomosis group
Patients chose HA group will performed in an end-to-end manner using absorbable suture material.
|
absorbable suture material is used to perform hand-sewn anastomosis in an end-to-end manner.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment success rate
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative time(minute)
Time Frame: 1 year
|
the operative time(minute) in two groups
|
1 year
|
Estimated blood loss(ml)
Time Frame: 1 year
|
the surgeon estimated blood loss(ml) in two groups
|
1 year
|
Time to initial oral feeding
Time Frame: 1 year
|
the time patients from operation to the first oral feeding.
|
1 year
|
Time to full oral feeding
Time Frame: 1 year
|
the time patients from operation to the full oral feeding.
|
1 year
|
anastomotic leakage and stricture
Time Frame: 1year
|
the incidence of complications include the anastomotic leakage and stricture between stapled anastomosis and hand-sewn anastomosis.
|
1year
|
ileus
Time Frame: 1 year
|
the incidence of ileus after operations 1 year in two groups
|
1 year
|
volvulus
Time Frame: 1 year
|
the incidence of Volvulus with adhesive bands and malrotation because of anastomotic dilatation in two groups after operation 1year
|
1 year
|
reoperation
Time Frame: 1 year
|
the incidence of complication requiring reoperation
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
classification
Time Frame: 3 year
|
counted the classification of intestinal atresia
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yuanmei Liu, Zunyi Medical College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2018
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
November 25, 2018
First Submitted That Met QC Criteria
November 26, 2018
First Posted (Actual)
November 27, 2018
Study Record Updates
Last Update Posted (Actual)
November 28, 2018
Last Update Submitted That Met QC Criteria
November 26, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Zunyi Medical University
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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