Adhesions
Conditions
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.
Interventions
DEVICEpolylactide-caprolactone-trimethylenecarbonate copolymer
Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum
DEVICEIcodextrin 4%
1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation
Sponsors
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Requirement for re-operation | 3 months |
| Dysmenorrhoea | 3 months |
| Dyspareunia | 3 months |
| Constipation | 3 months |
| Diarrhoea | 3 months |
| Post-operative infection | 3 months |
| Use of analgesia | 1, 2 and 3 days |
| Post-operative pyrexia | 3 months |
| Duration of adhesion prophylaxis | Day 1 |
| Usability as assessed by surgeon | Day 1 |
| Nausea | 3 months |
Countries
Germany
Outcome results
None listed