Intestinal AtresiaSAVSHANCT03754907
Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia
A study testing Endocutter stapler and suture material in people with Intestinal Atresia and Anastomotic Complication, run by Zunyi Medical College at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Intestinal Atresia, Anastomotic Complication
- What is being tested?
- Endocutter stapler and suture material
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients were eligible if they were between 1 day and 30 days of age, and if they suffered from intestinal atresia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Rongruo Liao, +868518608225, zzbhaofan@sina.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Intestinal Atresia, Anastomotic Complication
- Being tested
- Endocutter stapler, suture material
- Keywords
- stapled anastomosis, hand-sewn anastomosis, intestinal atresia, neonate
- Medical subject headings
- Intestinal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocutter staplerProcedure or surgery
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 materialProcedure or surgery
absorbable suture material is used to perform hand-sewn anastomosis in an end-to-end manner.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endocutter stapler |
| hand-sewn anastomosis group | Active comparator | Patients chose HA group will performed in an end-to-end manner using absorbable suture material. Receives: Procedure: suture material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (8)
Operative time(minute)
the operative time(minute) in two groups
Measured: 1 year
Estimated blood loss(ml)
the surgeon estimated blood loss(ml) in two groups
Measured: 1 year
Time to initial oral feeding
the time patients from operation to the first oral feeding.
Measured: 1 year
Time to full oral feeding
the time patients from operation to the full oral feeding.
Measured: 1 year
anastomotic leakage and stricture
the incidence of complications include the anastomotic leakage and stricture between stapled anastomosis and hand-sewn anastomosis.
Measured: 1year
ileus
the incidence of ileus after operations 1 year in two groups
Measured: 1 year
volvulus
the incidence of Volvulus with adhesive bands and malrotation because of anastomotic dilatation in two groups after operation 1year
Measured: 1 year
reoperation
the incidence of complication requiring reoperation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intestinal AtresiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zunyi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zebing Zheng, Zunyi Medical College
- Investigators
- Yuanmei Liu, Study director, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754907
- Sponsor's protocol ID
- Zunyi Medical University
- Acronym
- SAVSHA
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 22864546Amano 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.
PubMed 29792281Zheng 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.
PubMed 35404135
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Stapled Anastomosis With Hand-sewn in Neonate With Intestinal Atresia
- ClinicalTrials.gov ID
- NCT03754907
- Acronym / sponsor ID
- SAVSHA / Zunyi Medical University
- Conditions
- Intestinal Atresia, Anastomotic Complication
- Keywords
- stapled anastomosis, hand-sewn anastomosis, intestinal atresia, neonate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zunyi Medical CollegeUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stapled anastomosis group | Experimental | Procedure: Endocutter staplerFollowing 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 materialPatients chose HA group will performed in an end-to-end manner using absorbable suture material. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients were eligible if they were between 1 day and 30 days of age, and if they suffered from intestinal atresia.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocutter staplerEndocutter 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) | Procedure or surgery | stapled anastomosis group |
| suture materialabsorbable suture material is used to perform hand-sewn anastomosis in an end-to-end manner. | Procedure or surgery | hand-sewn anastomosis group |
Primary outcome
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).
8 secondary outcomes
Operative time(minute)
Time frame: 1 year
Estimated blood loss(ml)
Time frame: 1 year
Time to initial oral feeding
Time frame: 1 year
Time to full oral feeding
Time frame: 1 year
anastomotic leakage and stricture
Time frame: 1year
ileus
Time frame: 1 year
volvulus
Time frame: 1 year
reoperation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Background: PubMed 22864546Sato 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.
- Background: PubMed 29792281Amano 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.
- Derived from this study: PubMed 35404135Zheng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuanmei Liu study director
Zunyi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocutter stapler and suture material in people with Intestinal Atresia and Anastomotic Complication, run by Zunyi Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zebing zheng, MD (18285269257, zebing1988@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754907, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.