Back to resultsSafety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
Primary Purpose
Adhesions
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
polylactide-caprolactone-trimethylenecarbonate copolymer
Icodextrin 4%
Sponsored by
About this trial
This is an interventional prevention trial for Adhesions
Eligibility 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
Sites / Locations
- Universitäts-Frauenklinik Tübingen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission
Secondary Outcome Measures
Use of analgesia
Post-operative pyrexia
Post-operative infection
Requirement for re-operation
Dysmenorrhoea
Dyspareunia
Constipation
Diarrhoea
Nausea
Duration of adhesion prophylaxis
Usability as assessed by surgeon
Full Information
NCT ID
NCT00597662
First Posted
January 9, 2008
Last Updated
June 9, 2008
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT00597662
Brief Title
Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
Official Title
Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesions
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
polylactide-caprolactone-trimethylenecarbonate copolymer
Intervention Description
Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum
Intervention Type
Device
Intervention Name(s)
Icodextrin 4%
Intervention Description
1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation
Primary Outcome Measure Information:
Title
Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Use of analgesia
Time Frame
1, 2 and 3 days
Title
Post-operative pyrexia
Time Frame
3 months
Title
Post-operative infection
Time Frame
3 months
Title
Requirement for re-operation
Time Frame
3 months
Title
Dysmenorrhoea
Time Frame
3 months
Title
Dyspareunia
Time Frame
3 months
Title
Constipation
Time Frame
3 months
Title
Diarrhoea
Time Frame
3 months
Title
Nausea
Time Frame
3 months
Title
Duration of adhesion prophylaxis
Time Frame
Day 1
Title
Usability as assessed by surgeon
Time Frame
Day 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diethelm Wallwiener, Prof. Dr.
Organizational Affiliation
Universitäts-Frauenklinik Tübingen
Official's Role
Study Chair
Facility Information:
Facility Name
Universitäts-Frauenklinik Tübingen
City
Tübingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
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