Gastrointestinal DiseasesPhase 4NCT00645684
Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil)
A Phase 4 study testing Gastrointestinal Anastomosis in people with Gastrointestinal Diseases and Laparotomy, run by Aesculap AG at 3 sites in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Diseases, Laparotomy, Anastomosis, Surgical
- What is being tested?
- Gastrointestinal Anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesHungary
- Study dates
- Apr 1998to May 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Hungary3 sites
Bugat Pal Korhaz, Sebeszeti Osztaly
Gyöngyös
B.-A.-Z. Megyei Korhaz, Sebeszeti Osztaly
Miskolc
Medical School of University Pecs
Pécs
About this study
Official title: Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil) One Layer Running(A) vs. Two-Layer Suture Technique (B)
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.
- Being tested
- Gastrointestinal Anastomosis
- Keywords
- Gastrointestinal Anastomosis, Multicentre, Randomized controlled single-blind study, synthetic, absorbable, braided and coated suture material, Laparotomy
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrointestinal AnastomosisProcedure or surgery
Also called SAFIL®: is a mid-term braided and coated synthetic absorbable suture made of, pure polyglycolic acid.
Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | one layer running suture technique Receives: Procedure: Gastrointestinal Anastomosis |
| B | Experimental | two-layer suture technique Receives: Procedure: Gastrointestinal Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of postoperative Complications
Measured: discharge, 1 month and a maximum of 3-4 months
Secondary outcomes (4)
handling characteristics
Measured: intraoperative
Operation time to construct the first anastomosis
Measured: intraoperative
length of hospitalization
Measured: postoperative
costs of suture material
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startApr 1998
- Primary completionSep 2001
- Study completionMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- György Weber, MD, PhD, Principal investigator, Medical School of University Pecs, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00645684
- Sponsor's protocol ID
- BBS-WV-H-0219
- Status last verified
- Mar 2008
- First submitted
- 25 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil) One Layer Running(A) vs. Two-Layer Suture Technique (B)
- ClinicalTrials.gov ID
- NCT00645684
- Acronym / sponsor ID
- BBS-WV-H-0219
- Keywords
- Gastrointestinal Anastomosis, Multicentre, Randomized controlled single-blind study, synthetic, absorbable, braided and coated suture material, Laparotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Primary completion
- Sep 2001 (actual)
- Study completion
- May 2002 (actual)
- First posted
- 28 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Gastrointestinal Anastomosisone layer running suture technique |
| B | Experimental | Procedure: Gastrointestinal Anastomosistwo-layer suture technique |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastrointestinal AnastomosisAlso: SAFIL®: is a mid-term braided and coated synthetic absorbable suture made of, pure polyglycolic acid.Gastrointestinal Anastomosis with synthetic, absorbable, coated suture material using two different suture-techniques | Procedure or surgery | A, B |
Primary outcome
Frequency of postoperative Complications
Time frame: discharge, 1 month and a maximum of 3-4 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
György Weber, MD, PhD principal investigator
Medical School of University Pecs, Hungary
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gastrointestinal Anastomosis in people with Gastrointestinal Diseases and Laparotomy, run by Aesculap AG at 3 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of postoperative Complications (time frame: discharge, 1 month and a maximum of 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2008.