A Phase 4 interventional study of Gastrointestinal Anastomosis in Gastrointestinal Diseases, Laparotomy and Anastomosis, Surgical, sponsored by Aesculap AG. Completed at 3 sites in Hungary. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-03-28.
Sponsored by Aesculap AG · Phase 4, Interventional, and Treatment
The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal surgery as part of a controlled randomized single blinded parallel group trial. The applicability and safety of the strand material used in two suture techniques (2-layer suture technique vs. 1-layer running) are to be tested on the basis of handling characteristics, the operative time consumed for the construction of the 1st anastomosis, the average time of the hospital duration for both patient groups, and the frequency of postoperative complications after discharge, 1 month and a maximum of 3-4 months. The used suture units are counted and the length of sutures determined which will be an indirect measurement of the costs of suture material for the two techniques.
628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.
This study's enrollment of 210 is above the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
one layer running suture technique
Procedure: Gastrointestinal Anastomosis
two-layer suture technique
Procedure: Gastrointestinal Anastomosis
Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques
Also known as: SAFIL®: is a mid-term braided and coated synthetic absorbable suture made of, pure polyglycolic acid.
Frequency of postoperative Complications
Time frame: discharge, 1 month and a maximum of 3-4 months
handling characteristics
Time frame: intraoperative
Operation time to construct the first anastomosis
Time frame: intraoperative
length of hospitalization
Time frame: postoperative
costs of suture material
Time frame: intraoperative
This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.
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