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

Crohn Disease Clinical Trial

Official title:

Biodegradable Stenting Anastomoses Versus Double-layer Hand Sutures for Reconstruction in Surgery of Intestinal Anastomosis: A Multicenter, Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02752360
• Other study ID #: BjFH20160410-1
• Status: Recruiting
• Phase: Phase 1
• First received: April 19, 2016
• Last updated: June 18, 2017
• Start date: April 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Beijing Friendship Hospital
• Contact: Guocong Wu, Doctor
• Phone: +86 13810354857
• Email: dr.wuguocong[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: December 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Crohn Disease
• Diverticulosis, Colonic
• Diverticulum

Intervention

Procedure:
• 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.
• 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.).

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Peking University Third Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7-10 Days
Primary	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.	2 Weeks
Primary	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.	6 Months
Secondary	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.	6 Months
Secondary	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	6 Months
Secondary	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.	6 Months
Secondary	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	1 Day