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

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

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.

Study Overview

• Status: Unknown
• Conditions: Crohn Disease; Colonic Neoplasms; Diverticulosis, Colonic
• Intervention / Treatment: Procedure: Biodegradable Stenting Anastomoses; Procedure: Double-layer Hand Sutures

• Study Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guocong Wu, Doctor; Phone Number: +86 13810354857; Email: dr.wuguocong@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital
      • Contact: Guocong Wu, Doctor; Phone Number: +86 13810354857; Email: dr.wuguocong@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BSA Group; Patients accept the management of Biodegradable Stenting Anastomoses for reconstruction in the surgery of Intestinal Anastomosis	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.
Experimental: DHS Group; Patients accept the management of Double-layer Hand Sutures for reconstruction in the surgery of Intestinal Anastomosis	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.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Zhejiang Cancer Hospital; Peking University Third Hospital
• Investigators: Study Chair: Zhongtao Zhang, Doctor, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 27, 2016

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 18, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: intestinal reconstruction; end to end anastomosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Inflammatory Bowel Diseases; Crohn Disease; Colonic Neoplasms; Diverticulum; Diverticular Diseases; Diverticulosis, Colonic
• Other Study ID Numbers: BjFH20160410-1