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

NCT ID: NCT02752360

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-12-31

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.

Conditions

Colonic Neoplasms; Diverticulosis, Colonic; Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BSA Group

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

Group Type: EXPERIMENTAL

Biodegradable Stenting Anastomoses

Intervention Type: PROCEDURE

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.

DHS Group

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

Group Type: EXPERIMENTAL

Double-layer Hand Sutures

Intervention Type: PROCEDURE

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.).

Interventions

Biodegradable Stenting Anastomoses

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.

Intervention Type: PROCEDURE

Double-layer Hand Sutures

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.).

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhongtao Zhang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhongtao Zhang, Doctor

Role: STUDY_CHAIR

Beijing Friendship Hospital

Locations

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guocong Wu, Doctor

Role: CONTACT

dr.wuguocong@qq.com

+86 13810354857

Facility Contacts

Guocong Wu, Doctor

Role: primary

dr.wuguocong@qq.com

+86 13810354857

Other Identifiers

BjFH20160410-1

Identifier Type: -

Identifier Source: org_study_id