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

Capital Medical University

Status and phase: Unknown; Phase 1

Conditions: Diverticulosis, Colonic; Colonic Neoplasms; Crohn Disease

Treatments: Procedure: Biodegradable Stenting Anastomoses; Procedure: Double-layer Hand Sutures

Study type: Interventional

Funder types: Other

Identifiers

NCT02752360

BjFH20160410-1

Details and patient eligibility

About

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.

Enrollment: 288 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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288 participants in 2 patient groups

BSA Group

Experimental group

Description:

Patients accept the management of Biodegradable Stenting Anastomoses for reconstruction in the surgery of Intestinal Anastomosis

Treatment:

Procedure: Biodegradable Stenting Anastomoses

DHS Group

Experimental group

Description:

Patients accept the management of Double-layer Hand Sutures for reconstruction in the surgery of Intestinal Anastomosis

Treatment:

Procedure: Double-layer Hand Sutures