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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014