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Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00597662
First received: January 9, 2008
Last updated: June 9, 2008
Last verified: June 2008
History of Changes
  Purpose

The purpose of this study is to compare adhesion prophylaxis with polylactide-caprolactone-trimethylenecarbonate copolymer to icodextrin 4% in terms of safety, side effects and usability in addition to gaining early evidence of the effectiveness of polylactide-caprolactone-trimethylenecarbonate copolymer.


Condition Intervention Phase
Adhesions
 Device: polylactide-caprolactone-trimethylenecarbonate copolymer
Device: Icodextrin 4%
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis

Resource links provided by NLM:

MedlinePlus related topics: Adhesions
Drug Information available for: Icodextrin
U.S. FDA Resources

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Use of analgesia [ Time Frame: 1, 2 and 3 days ] [ Designated as safety issue: Yes ]
  • Post-operative pyrexia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Post-operative infection [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Requirement for re-operation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Dysmenorrhoea [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Dyspareunia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Constipation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Diarrhoea [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Nausea [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Duration of adhesion prophylaxis [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Usability as assessed by surgeon [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: polylactide-caprolactone-trimethylenecarbonate copolymer
Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum
Active Comparator: 2 Device: Icodextrin 4%
1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-60 years
  • sex female
  • laparoscopic myomectomy indicated
  • ability and intention to conform to the study protocol
  • written informed consent

Exclusion Criteria:

  • pregnancy
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597662

Locations
Germany
Universitäts-Frauenklinik Tübingen
Tübingen, Baden-Wuerttemberg, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Study Chair: Diethelm Wallwiener, Prof. Dr. Universitäts-Frauenklinik Tübingen
  More Information

No publications provided

Responsible Party: Prof. Dr. D. Wallwiener, Universitäts-Frauenklinik Tübingen
ClinicalTrials.gov Identifier: NCT00597662     History of Changes
Other Study ID Numbers: SUP-002
Study First Received: January 9, 2008
Last Updated: June 9, 2008
Health Authority: Germany: Regierungspräsidium Tübingen

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013