NCT00597662

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Last Updated

June 10, 2008

Status Verified

June 1, 2008

Enrollment Period

3 months

First QC Date

January 9, 2008

Last Update Submit

June 9, 2008

Conditions

Adhesions

Outcome Measures

Primary Outcomes (1)

  • Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission

    3 months

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Device: polylactide-caprolactone-trimethylenecarbonate copolymer

2

ACTIVE COMPARATOR
Device: Icodextrin 4%

Interventions

polylactide-caprolactone-trimethylenecarbonate copolymerDEVICE

Polylactide-caprolactone-trimethylenecarbonate copolymer membrane is applied directly over the surgical scar on the visceral peritoneum

1
Icodextrin 4%DEVICE

1 liter icodextrin 4% is instilled into the peritoneal cavity at the end of the operation

2

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-60 years
  • sex female
  • laparoscopic myomectomy indicated
  • ability and intention to conform to the study protocol
  • written informed consent

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäts-Frauenklinik Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Diethelm Wallwiener, Prof. Dr.

    Universitäts-Frauenklinik Tübingen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

January 1, 2008

Primary Completion

April 1, 2008

Last Updated

June 10, 2008

Record last verified: 2008-06

Locations

DE(1)