Clinical Trial: Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Intestinal Anastomosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Surgery of Intestinal Anastomosis: A Multicenter, Prospective Cohort Study

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.

Detailed Summary:
Sponsor: Beijing Friendship Hospital

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participant with abnormal laboratory values [ Time Frame: 6 Months ]
    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.
  • Severe adverse events (SAEs) [ Time Frame: 6 Months ]
    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
  • Whether the Biodegradable Stenting Anastomoses be eliminated or not [ Time Frame: 6 Months ]
    The X-ray 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.
  • The time of reconstruction in the surgery of Intestinal Anastomosis [ Time Frame: 1 Day ]
    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


Original Secondary Outcome: Same as current

Information By: Beijing Friendship Hospital

Dates:
Date Received: April 19, 2016
Date Started: April 2016
Date Completion: December 2017
Last Updated: April 22, 2016
Last Verified: April 2016