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Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

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. Identifier: NCT01344486
Recruitment Status : Terminated (Investigator no longer works fulltime at investigational site)
First Posted : April 29, 2011
Last Update Posted : October 25, 2016
Information provided by (Responsible Party):
Jasper Verguts, University Hospital, Gasthuisberg

Brief Summary:

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 or disease Intervention/treatment Phase
Endometriosis of the Cul-de-sac Chocolate Cyst of Ovary Fibroid/Myoma (Uterus/Cervix) Procedure: full conditioning Procedure: standard pneumoperitoneum Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
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
Study Start Date : September 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Post-operative pain [ Time Frame: recorded until 3 days after surgery ]
    pain assessed by VAS scores

  2. inflammation [ Time Frame: recorded until 3 days after surgery ]
    bloodsamples to test for C reactive protein and white blood cells

  3. 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)

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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)

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 identifier (NCT number): NCT01344486

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UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
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Principal Investigator: Philippe Koninckx, MD, PhD UZ Leuven
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Responsible Party: Jasper Verguts, MD, PhD, University Hospital, Gasthuisberg Identifier: NCT01344486    
Other Study ID Numbers: S52424
First Posted: April 29, 2011    Key Record Dates
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:
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Genital Diseases, Female