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Peritoneal Cavity Conditioning During Laparoscopic Surgery Decreases Postoperative Pain, Inflammatory Reaction and Postoperative Adhesions


N/A
N/A
N/A
Open (Enrolling)
Female
Endometriosis of the Cul-de-sac, Chocolate Cyst of Ovary, Fibroid/Myoma (Uterus/Cervix)

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Trial Information

Peritoneal Cavity Conditioning During Laparoscopic Surgery Decreases Postoperative Pain, Inflammatory Reaction and Postoperative Adhesions


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

adhesion formation after laparoscopic surgery

Outcome Description:

second look laparoscopy to assess adhesions formed after initial surgery

Outcome Time Frame:

2 weeks after primary surgery

Safety Issue:

No

Authority:

Belgium: Institutional Review Board

Study ID:

S52424

NCT ID:

NCT01344486

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Endometriosis of the Cul-de-sac
  • Chocolate Cyst of Ovary
  • Fibroid/Myoma (Uterus/Cervix)
  • women undergoing laparoscopic surgery
  • Endometriosis
  • Leiomyoma
  • Ovarian Cysts

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