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

Study Overview
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Brief Summary
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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.

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

Conditions
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Adhesions

Intervention / Treatment
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* Device: polylactide-caprolactone-trimethylenecarbonate copolymer
* Device: Icodextrin 4%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: polylactide-caprolactone-trimethylenecarbonate copolymer<br>* Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum<br>|
| Active Comparator: 2<br> | Device: Icodextrin 4%<br>* 1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of analgesia |  | 1, 2 and 3 days | 
| Post-operative pyrexia |  | 3 months | 
| Post-operative infection |  | 3 months | 
| Requirement for re-operation |  | 3 months | 
| Dysmenorrhoea |  | 3 months | 
| Dyspareunia |  | 3 months | 
| Constipation |  | 3 months | 
| Diarrhoea |  | 3 months | 
| Nausea |  | 3 months | 
| Duration of adhesion prophylaxis |  | Day 1 | 
| Usability as assessed by surgeon |  | Day 1 |