Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

University Hospital, Gasthuisberg

Status and phase: Terminated; Phase 4

Conditions: Chocolate Cyst of Ovary; Endometriosis of the Cul-de-sac; Fibroid/Myoma (Uterus/Cervix)

Treatments: Procedure: full conditioning; Procedure: standard pneumoperitoneum

Study type: Interventional

Funder types: Other

Identifiers

NCT01344486

S52424

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups

Full conditioing

Experimental group

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

Treatment:

Procedure: full conditioning

carbon dioxide

Active Comparator group

Description:

induction pneumoperitoneum with carbon dioxide 100%

Treatment:

Procedure: standard pneumoperitoneum