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

Phase 1

Completed

• Conditions: Adhesions
• Interventions: Device: polylactide-caprolactone-trimethylenecarbonate copolymer; Device: Icodextrin 4%

• Registration Number: NCT00597662
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-09
• Study First Submitted QC: 2008-01-17
• Study First Posted: 2008-01-18
• Primary Completion: 2008-04
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-09
• Last Update Posted: 2008-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	polylactide-caprolactone-trimethylenecarbonate copolymer	-
2	Icodextrin 4%	-

Primary Outcome Measures

Name	Time	Method
Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitäts-Frauenklinik Tübingen; 🇩🇪 Tübingen, Baden-Wuerttemberg, Germany