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

Primary Purpose

Colonic Neoplasms, Diverticulosis, Colonic, Crohn Disease

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Biodegradable Stenting Anastomoses
Double-layer Hand Sutures
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Neoplasms focused on measuring intestinal reconstruction, end to end anastomosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Beijing Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BSA Group

DHS Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Anastomotic Leakage Rate
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
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
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

Number of participant with abnormal laboratory values
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)
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
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.
The time of reconstruction in the surgery of Intestinal Anastomosis
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

Full Information

First Posted
April 19, 2016
Last Updated
June 18, 2017
Sponsor
Beijing Friendship Hospital
Collaborators
Peking University Third Hospital, Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02752360
Brief Title
Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Intestinal Anastomosis
Official Title
Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Surgery of Intestinal Anastomosis: A Multicenter, Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
Collaborators
Peking University Third Hospital, Zhejiang Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms, Diverticulosis, Colonic, Crohn Disease
Keywords
intestinal reconstruction, end to end anastomosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
288 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BSA Group
Arm Type
Experimental
Arm Description
Patients accept the management of Biodegradable Stenting Anastomoses for reconstruction in the surgery of Intestinal Anastomosis
Arm Title
DHS Group
Arm Type
Experimental
Arm Description
Patients accept the management of Double-layer Hand Sutures for reconstruction in the surgery of Intestinal Anastomosis
Intervention Type
Procedure
Intervention Name(s)
Biodegradable Stenting Anastomoses
Intervention Description
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
Intervention Name(s)
Double-layer Hand Sutures
Intervention Description
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.).
Primary Outcome Measure Information:
Title
Anastomotic Leakage Rate
Description
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.
Time Frame
7-10 Days
Title
Anastomotic Hemorrhage Rate
Description
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.
Time Frame
2 Weeks
Title
Anastomotic Stenosis Rate
Description
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.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Number of participant with abnormal laboratory values
Description
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.
Time Frame
6 Months
Title
Severe adverse events (SAEs)
Description
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
Time Frame
6 Months
Title
Whether the Biodegradable Stenting Anastomoses be eliminated or not
Description
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.
Time Frame
6 Months
Title
The time of reconstruction in the surgery of Intestinal Anastomosis
Description
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
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guocong Wu, Doctor
Phone
+86 13810354857
Email
dr.wuguocong@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongtao Zhang, Doctor
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guocong Wu, Doctor
Phone
+86 13810354857
Email
dr.wuguocong@qq.com

12. IPD Sharing Statement

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

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