Clinical trial · Interventional
Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions
Peritoneal Cavity Conditioning During Laparoscopic Surgery Decreases Postoperative Pain, Inflammatory Reaction and Postoperative Adhesions
NCT01344486CI-TRIAL-00024416terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigator no longer works fulltime at investigational site
Summary
Brief summary (as posted)
Full conditioning of the peritoneal cavity during laparoscopic surgery will decrease post-operative pain, inflammation and adhesion formation. Full conditioning will decrease an inflammatory response of the peritoneum and decrease pain and adhesion formation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chocolate Cyst of Ovary | — | UNRESOLVED | — |
| Endometriosis of the Cul-de-sac | — | UNRESOLVED | — |
| Fibroid/Myoma (Uterus/Cervix) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| full conditioning | Procedure | — | UNRESOLVED |
| standard pneumoperitoneum | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Full conditioing
- description
- Intervention by alteration of laparoscopic gas with addition of oxygen and nitrous oxide, regulation of humidification and temperature (32°C), injection of 5mg Dexamethasone and application of Hyalobarrier Gel Endo (Nordic Pharma) at the surgical wound
- interventionNames
- Procedure: full conditioning
- type
- ACTIVE_COMPARATOR
- label
- carbon dioxide
- description
- induction pneumoperitoneum with carbon dioxide 100%
- interventionNames
- Procedure: standard pneumoperitoneum
Primary outcomes (1)
- measure
- adhesion formation after laparoscopic surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * women undergoing laparoscopic excision of deep endometriosis (stratum 1), excision of endometrioma's (stratum 2) or excision of uterine myoma's (stratum 3) since this is severe surgery, associated with severe postoperative adhesions and since for most of these women fertility is important and hence the second look laparoscopy can be beneficial. * Signed informed consent Exclusion Criteria: * women with a pre-existing condition increasing the risk of surgery such as clotting disorders, heart or lung impairment etc.-Any condition that might interfere with inflammatory parameters such as immunodeficiency, chronic inflammatory disease as Crohn's disease. * Pregnancy * Conditions associated with chronic pain as peripheral neuropathy, pathology of the vertebral column and osteo-articular disease. Conditions causing acute pain e.g. abdominal trauma * a known allergic reaction to Hyalobarrier Gel Endo® * A bowel lesion requiring a single or double layer suture. (given that for none of the anti-adhesion barriers safety has been proven following bowel lesions and suture)
References
Publications (0)
Data not yet available
No reference posted for this study.