NCT02752360|UnknownPhase 1DMC
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Sponsor study identifier
interventional
288
1 country
1
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Intestinal anastomosis plays an important role in various general surgeries, but the complications such as anastomotic leakage,stenosis and hemorrhage cannot been avoided. Although many ways are put up to solve this problem, there are still many imports need to improve. Therefore, the Biodegradable Stenting Anastomoses(BSA), which make intestinal anastomosis easily and less complications, have been produced.The major goal of this study is to evaluate the efficacy of Biodegradable Stenting Anastomoses(BSA) for reconstruction in surgery of intestinal anastomosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
April 19, 2016
Actual (reported)April 27, 2016
Actual (reported)May 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Anastomotic Leakage Rate
The patients with anastomotic leakage / the total patients. The definition of anastomotic leakage in this study, is included one of the situation as follows: (1) peritonitis caused by leakage, pelvic abscess without radiologically proven anastomotic leakage were considered as equivalents of clinically anastomotic leakage as defined above.; (2) Discharge of faeces, pus or gas from the abdominal drain; (3) All anastomotic leakages were confirmed by one or more of the following methods such as CT scan, ultrasonography and laparotomy.
7-10 Days
Anastomotic Hemorrhage Rate
The patients with anastomotic hemorrhage / the total patients. Anastomotic bleeding was considered gastrointestinal bleeding after surgery, and it ascertains that the bleeding is from anastomosis with endoscopy.
2 Weeks
Anastomotic Stenosis Rate
The patients with anastomotic stenosis / the total patients.Anastomotic stenosis which is not caused by tumor in the patients with complete or incomplete intestinal obstruction symptoms.
6 Months
Number of participant with abnormal laboratory values
6 Months
Severe adverse events (SAEs)
6 Months
Whether the Biodegradable Stenting Anastomoses be eliminated or not
6 Months
The time of reconstruction in the surgery of Intestinal Anastomosis
1 Day
Patients accept the management of Biodegradable Stenting Anastomoses for reconstruction in the surgery of Intestinal Anastomosis
Patients accept the management of Double-layer Hand Sutures for reconstruction in the surgery of Intestinal Anastomosis
Biodegradable Stenting Anastomoses(BSA) is a new method and device which helps to make intestinal anastomosis easily. According to the measurement of intestinal canal diameter, chose an appropriate size of BSA and use the Seromuscular layer Purse-string Suture to stitch with an absorbable line (VCP311, Ethicon, Inc.) away from the end 0.5 to 1.0 cm and not knot temporarily, then open and sterilize intestinal canal fully, and place the BSA into the intestinal canal at appropriate position before tightening knot. Last, the interrupted whole layer inversion suture is used to fix.
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
Zhongtao Zhang, Doctor
Beijing Friendship Hospital
First Submitted
April 19, 2016
First Posted
April 27, 2016
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2018
Double-layer Hand Sutures(DHS)is a surgery way that is to use the single-layer continous Hand Sutures,then Lembert to stitch with an absorbable line (VCP311, Ethicon, Inc.).
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 20, 2017
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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