Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Intestinal Anastomosis
1 other identifier
interventional
288
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 19, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 20, 2017
June 1, 2017
2.1 years
April 19, 2016
June 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (4)
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
Study Arms (2)
BSA Group
EXPERIMENTALPatients accept the management of Biodegradable Stenting Anastomoses for reconstruction in the surgery of Intestinal Anastomosis
DHS Group
EXPERIMENTALPatients accept the management of Double-layer Hand Sutures for reconstruction in the surgery of Intestinal Anastomosis
Interventions
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.).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Friendship Hospitallead
- Peking University Third Hospitalcollaborator
- Zhejiang Cancer Hospitalcollaborator
Study Sites (1)
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhongtao Zhang, Doctor
Beijing Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
April 19, 2016
First Posted
April 27, 2016
Study Start
April 1, 2016
Primary Completion
May 1, 2018
Study Completion
December 1, 2018
Last Updated
June 20, 2017
Record last verified: 2017-06