Clinical trial NCT00645684: Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil)
Official title: Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil) One Layer Running(A) vs. Two-Layer Suture Technique (B)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Diseases
Laparotomy
Anastomosis, Surgical
Absorbable, Coated Sutures
Keywords: Gastrointestinal Anastomosis
Multicentre
Randomized controlled single-blind study
synthetic, absorbable, braided and coated suture material
Laparotomy
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes, undergoing a gastrointestinal hand made one-layer running (A) or two-layer (B) anastomotic procedure where the use of synthetic absorbable surgical suture material is indicated.
* Written consent to participate in the study

Exclusion Criteria:

* Emergency patients that cannot be properly informed about the clinical trial and cannot give their written consent
* Pregnancy or lactation period
* Patients suffering from a diffuse purulent peritonitis or generalized diseases, which can have consequences for the healing of the asnastomosis (e.g. ubalanced diabetes, progressed uremia, massive hypoproteinaemia, sever jaundice, generalized intraabdominal tumor metastases, severe tumorous cachexia, severe avitaminosis, chronic liver disease.
* Patients who are undergoing a therapeutic procedure, which can have consequences for the healing of the anastomosis (e.g. treatment with corticosteroids or cytostatics, local radiation in the operating area)
* Laparoscopial Procedures
* Patients who are not willing to cooperate and legally incapacitated people

Primary outcomes:
measure: Frequency of postoperative Complications
timeFrame: discharge, 1 month and a maximum of 3-4 months
Secondary outcomes:
measure: handling characteristics
timeFrame: intraoperative
measure: Operation time to construct the first anastomosis
timeFrame: intraoperative
measure: length of hospitalization
timeFrame: postoperative
measure: costs of suture material
timeFrame: intraoperative
Other outcomes:
Locations:
city: Gyöngyös
country: Hungary
facility: Bugat Pal Korhaz, Sebeszeti Osztaly
city: Miskolc
country: Hungary
facility: B.-A.-Z. Megyei Korhaz, Sebeszeti Osztaly
city: Pecs
country: Hungary
facility: Medical School of University Pecs
Study officials:
affiliation: Medical School of University Pecs, Hungary
name: György Weber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: