Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Surgery of Intestinal Anastomosis: A Multicenter, Prospective Cohort Study
Overview
- Phase
- Phase 1
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 288
- Locations
- 1
- Primary Endpoint
- Anastomotic Leakage Rate
Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with age between 18 - 80 years.
- •Patients with operation of end to end anastomosis of colon or small intestine.
- •Patients without previous surgery during 3 months.
- •Patients who understand the nature of this trial and provide informed consent.
Exclusion Criteria
- •Patients with severe cardiopulmonary disease or other severe disease.
- •Patients who are psychopath, pregnant, and child without capacity for civil conduct.
- •Patients with complete intestinal obstruction.
- •Patients with abdominal cavity infection.
- •Patients who are treating by drug such as adrenal cortical hormone and immune inhibitors, chemotherapy drugs, radiation and so on.
- •Patients who need to accept the anastomosis between rectum and colon.
- •Patients who are required to accept intestinal anastomosis twice or more.
- •Patients who are required to accept the treatment of colostomy.
- •other conditions that render a patient unsuitable for the trial as determined by the study investigators.
Outcomes
Primary Outcomes
Anastomotic Leakage Rate
Time Frame: 7-10 Days
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.
Anastomotic Hemorrhage Rate
Time Frame: 2 Weeks
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.
Anastomotic Stenosis Rate
Time Frame: 6 Months
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.
Secondary Outcomes
- Severe adverse events (SAEs)(6 Months)
- Whether the Biodegradable Stenting Anastomoses be eliminated or not(6 Months)
- Number of participant with abnormal laboratory values(6 Months)
- The time of reconstruction in the surgery of Intestinal Anastomosis(1 Day)
Investigators
Zhongtao Zhang
Doctor
Beijing Friendship Hospital