Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
NCT ID: NCT00597662
Last Updated: 2008-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
polylactide-caprolactone-trimethylenecarbonate copolymer
Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum
2
Icodextrin 4%
1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation
Interventions
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polylactide-caprolactone-trimethylenecarbonate copolymer
Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum
Icodextrin 4%
1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation
Eligibility Criteria
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Inclusion Criteria
* sex female
* laparoscopic myomectomy indicated
* ability and intention to conform to the study protocol
* written informed consent
Exclusion Criteria
* indication for laparotomy
* inflammatory bowel disease
* additional surgical interventions
* known or suspected intollerance or hypersensibility to the interventions
* chronic pain
* systemic corticoids or irradiation
* alcohol abuse or other substance abuse
* clinical signs of malignancy
* psychiatric or neurological disease
* participation in another clinical trial within 30 days
* inability to understand the purpose of the trial or to conform to the study protocol
* absence of written informed consent
* inflammation of pelvic organs
* presence of adhesions which lead to a conversion from laparoscopy to laparotomy
* concurrent therapy with corticoids, anti-neoplastic agents or irradiation
* maintenance therapy with non-steroidal anti-inflammatory drugs or analgesics
18 Years
60 Years
FEMALE
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Universitäts-Frauenklinik Tübingen
Principal Investigators
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Diethelm Wallwiener, Prof. Dr.
Role: STUDY_CHAIR
Universitäts-Frauenklinik Tübingen
Locations
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Universitäts-Frauenklinik Tübingen
Tübingen, Baden-Wurttemberg, Germany
Countries
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Other Identifiers
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SUP-002
Identifier Type: -
Identifier Source: org_study_id