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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum
1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation
Universitäts-Frauenklinik Tübingen
Tübingen, Baden-Wurttemberg, Germany
Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission
Time frame: 3 months
Use of analgesia
Time frame: 1, 2 and 3 days
Post-operative pyrexia
Time frame: 3 months
Post-operative infection
Time frame: 3 months
Requirement for re-operation
Time frame: 3 months
Dysmenorrhoea
Time frame: 3 months
Dyspareunia
Time frame: 3 months
Constipation
Time frame: 3 months
Diarrhoea
Time frame: 3 months
Nausea
Time frame: 3 months
Duration of adhesion prophylaxis
Time frame: Day 1
Usability as assessed by surgeon
Time frame: Day 1
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