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

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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

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

Trial contacts and locations

1

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Central trial contact

Guocong Wu, Doctor

Data sourced from clinicaltrials.gov

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