Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

This study has been terminated.
(Investigator no longer works fulltime at investigational site: no inclusions possible)
Sponsor:
Information provided by (Responsible Party):
Jasper Verguts, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01344486
First received: April 21, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Endometriosis of the Cul-de-sac
Chocolate Cyst of Ovary
Fibroid/Myoma (Uterus/Cervix)
Procedure: full conditioning
Procedure: standard pneumoperitoneum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Peritoneal Cavity Conditioning During Laparoscopic Surgery Decreases Postoperative Pain, Inflammatory Reaction and Postoperative Adhesions

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • adhesion formation after laparoscopic surgery [ Time Frame: 2 weeks after primary surgery ] [ Designated as safety issue: No ]
    second look laparoscopy to assess adhesions formed after initial surgery


Secondary Outcome Measures:
  • Post-operative pain [ Time Frame: recorded until 3 days after surgery ] [ Designated as safety issue: No ]
    pain assessed by VAS scores

  • inflammation [ Time Frame: recorded until 3 days after surgery ] [ Designated as safety issue: No ]
    bloodsamples to test for C reactive protein and white blood cells

  • time to first flatus and stool [ Time Frame: recorded until 3 days after surgery ] [ Designated as safety issue: No ]
    patients will be asked when first flatus and first stool appeared. (measured as hours after surgery)


Enrollment: 22
Study Start Date: September 2010
Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Full conditioing
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
Procedure: full conditioning
addition of 4% oxygen + 10% nitrous oxide to the pneumoperitoneum + humidification + temperature regulation at 32°C
Active Comparator: carbon dioxide
induction pneumoperitoneum with carbon dioxide 100%
Procedure: standard pneumoperitoneum
100% carbon dioxide used for the pneumoperitoenum

Detailed Description:

Randomized controlled trial (RCT) comparing carbon dioxide to full conditioning (addition of oxygen, nitrous oxide, humidification and temperature control, dexamethasone and Hyalobarrier gel) Women undergoing laparoscopy for endometriosis, myomectomy or adhesiolysis will be randomized to either group and will be compared for pain (VAS scores); inflammation (White blood cells, CRP) and adhesions scored by second look laparoscopy.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344486

Locations
Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
  More Information

No publications provided

Responsible Party: Jasper Verguts, MD, PhD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01344486     History of Changes
Other Study ID Numbers: S52424
Study First Received: April 21, 2011
Last Updated: December 11, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Gasthuisberg:
women undergoing laparoscopic surgery

Additional relevant MeSH terms:
Endometriosis
Leiomyoma
Ovarian Cysts
Genital Diseases, Female
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 31, 2014