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Completed

NCT Number: NCT00597662

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

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.

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Key information

Conditions

Adhesions Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Tissue Adhesions

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Universitäts-Frauenklinik Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

polylactide-caprolactone-trimethylenecarbonate copolymer

Device

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

Icodextrin 4%

Device

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

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. Use of analgesia

    Time frame: 1, 2 and 3 days

  2. Post-operative pyrexia

    Time frame: 3 months

  3. Post-operative infection

    Time frame: 3 months

  4. Requirement for re-operation

    Time frame: 3 months

  5. Dysmenorrhoea

    Time frame: 3 months

  6. Dyspareunia

    Time frame: 3 months

  7. Constipation

    Time frame: 3 months

  8. Diarrhoea

    Time frame: 3 months

  9. Nausea

    Time frame: 3 months

  10. Duration of adhesion prophylaxis

    Time frame: Day 1

  11. Usability as assessed by surgeon

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
First posted
Jan 18, 2008
Registry last updated
Jun 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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