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

Phase 1

• Conditions: Colonic Neoplasms; Crohn Disease; Diverticulosis, Colonic
• Interventions: Procedure: Double-layer Hand Sutures; Procedure: Biodegradable Stenting Anastomoses

• Registration Number: NCT02752360
• Lead Sponsor: Beijing Friendship Hospital

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 Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-27
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-18
• Last Update Posted: 2017-06-20
• Primary Completion: 2018-05
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DHS Group	Double-layer Hand Sutures	Patients accept the management of Double-layer Hand Sutures for reconstruction in the surgery of Intestinal Anastomosis
BSA Group	Biodegradable Stenting Anastomoses	Patients accept the management of Biodegradable Stenting Anastomoses for reconstruction in the surgery of Intestinal Anastomosis

Primary Outcome Measures

Name	Time	Method
Anastomotic Leakage Rate	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	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	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 Outcome Measures

Name	Time	Method
Severe adverse events (SAEs)	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	6 Months	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.
Number of participant with abnormal laboratory values	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.
The time of reconstruction in the surgery of Intestinal Anastomosis	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

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China