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

NCT02752360 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2017-06-20

No results posted yet for this study

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

Interventions

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.

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.).

Sponsors & Collaborators

  • Peking University Third Hospital

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Beijing Friendship Hospital

    lead OTHER

Principal Investigators

  • Zhongtao Zhang, Doctor · Beijing Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-05-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02752360 on ClinicalTrials.gov