Clinical trial NCT02752360: Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Intestinal Anastomosis
Official title: Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Surgery of Intestinal Anastomosis: A Multicenter, Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Colonic Neoplasms
Diverticulosis, Colonic
Crohn Disease
Keywords: intestinal reconstruction
end to end anastomosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Zhejiang Cancer Hospital
First posted: 2016-04-27
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anastomotic Leakage Rate
timeFrame: 7-10 Days
measure: Anastomotic Hemorrhage Rate
timeFrame: 2 Weeks
measure: Anastomotic Stenosis Rate
timeFrame: 6 Months
Secondary outcomes:
measure: Number of participant with abnormal laboratory values
timeFrame: 6 Months
measure: Severe adverse events (SAEs)
timeFrame: 6 Months
measure: Whether the Biodegradable Stenting Anastomoses be eliminated or not
timeFrame: 6 Months
measure: The time of reconstruction in the surgery of Intestinal Anastomosis
timeFrame: 1 Day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhongtao Zhang, Doctor
role: STUDY_CHAIR
References: