We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

This study has been terminated.
(Investigator no longer works fulltime at investigational site)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344486
First Posted: April 29, 2011
Last Update Posted: October 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jasper Verguts, University Hospital, Gasthuisberg
  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 Phase
Endometriosis of the Cul-de-sac Chocolate Cyst of Ovary Fibroid/Myoma (Uterus/Cervix) Procedure: full conditioning Procedure: standard pneumoperitoneum Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Jasper Verguts, University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • adhesion formation after laparoscopic surgery [ Time Frame: 2 weeks after primary surgery ]
    second look laparoscopy to assess adhesions formed after initial surgery


Secondary Outcome Measures:
  • Post-operative pain [ Time Frame: recorded until 3 days after surgery ]
    pain assessed by VAS scores

  • inflammation [ Time Frame: recorded until 3 days after surgery ]
    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 ]
    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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344486


Locations
Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
Principal Investigator: Philippe Koninckx, MD, PhD UZ Leuven
  More Information

Responsible Party: Jasper Verguts, MD, PhD, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01344486     History of Changes
Other Study ID Numbers: S52424
First Submitted: April 21, 2011
First Posted: April 29, 2011
Last Update Posted: October 25, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Endometriosis
Ovarian Cysts
Genital Diseases, Female
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases