Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Gasthuisberg
Sponsor:
University Hospital, Gasthuisberg
Information provided by (Responsible Party):
Jasper Verguts, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01344486
First received: April 21, 2011
Last updated: January 11, 2013
Last verified: January 2013
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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 (Completed September 2011) Endometrioma (Completed September 2011) Myoma (Open) |
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)
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2010 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Full conditioing
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344486
Contacts
| Contact: Jasper Verguts, MD | 0032 16 340835 | jasper.verguts@uzleuven.be |
| Contact: Philippe Koninckx, MD, PhD | 0032 16 343606 |
Locations
| Belgium | |
| UZ Leuven | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: Jasper Verguts, MD 0032 16 340835 jasper.verguts@uzleuven.be | |
| Sub-Investigator: Jasper Verguts, MD | |
| Principal Investigator: Philippe R Koninckx, MD, PhD | |
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: | January 11, 2013 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by University Hospital, Gasthuisberg:
|
women undergoing laparoscopic surgery |
Additional relevant MeSH terms:
|
Endometriosis Myoma Genital Diseases, Female Neoplasms, Muscle Tissue |
Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013