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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
288
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.
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.).
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGAnastomotic 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 Months
Number of participant with abnormal laboratory values
Number of participant with abnormal laboratory values will be record. Laboratory tests include Blood routine/Coagulation/Liver and renal function/Electrolyte/Lipids/OB. Abnormal laboratory values means that values of Laboratory tests beyond the normal values.
Time frame: 6 Months
Severe adverse events (SAEs)
Severe adverse events (SAEs) refer to the following conditions: death, life-threatening or permanent or significant disability, permanent functional injury to the organs, hospitalization for emergencies or prolonged hospitalization
Time frame: 6 Months
Whether the Biodegradable Stenting Anastomoses be eliminated or not
The enteroscopy will be used to observe whether the Biodegradable Stenting Anastomoses be eliminated from body at 4th weeks after surgery.If Biodegradable Stenting Anastomoses be eliminated, contrast will be filling defect.
Time frame: 6 Months
The time of reconstruction in the surgery of Intestinal Anastomosis
The time of reconstruction in the surgery of Intestinal Anastomosis for each group is recorded, which is from the beginning to the ending of Intestinal Anastomosis
Time frame: 1 Day
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