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

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ClinicalTrials.gov Identifier: NCT00597662
Recruitment Status : Completed
First Posted : January 18, 2008
Last Update Posted : June 10, 2008
Sponsor:
Information provided by:
University Hospital Tuebingen

Brief Summary:
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 or disease Intervention/treatment Phase
Adhesions Device: polylactide-caprolactone-trimethylenecarbonate copolymer Device: Icodextrin 4% Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
Study Start Date : January 2008
Actual Primary Completion Date : April 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Use of analgesia [ Time Frame: 1, 2 and 3 days ]
  2. Post-operative pyrexia [ Time Frame: 3 months ]
  3. Post-operative infection [ Time Frame: 3 months ]
  4. Requirement for re-operation [ Time Frame: 3 months ]
  5. Dysmenorrhoea [ Time Frame: 3 months ]
  6. Dyspareunia [ Time Frame: 3 months ]
  7. Constipation [ Time Frame: 3 months ]
  8. Diarrhoea [ Time Frame: 3 months ]
  9. Nausea [ Time Frame: 3 months ]
  10. Duration of adhesion prophylaxis [ Time Frame: Day 1 ]
  11. Usability as assessed by surgeon [ Time Frame: Day 1 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Prof. Dr. D. Wallwiener, Universitäts-Frauenklinik Tübingen
ClinicalTrials.gov Identifier: NCT00597662     History of Changes
Other Study ID Numbers: SUP-002
First Posted: January 18, 2008    Key Record Dates
Last Update Posted: June 10, 2008
Last Verified: June 2008

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Icodextrin
Dialysis Solutions
Pharmaceutical Solutions