Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

University Hospital, Gasthuisberg

Status: Completed

Conditions: Laparoscopic Hysterectomy

Treatments: Procedure: Carbon dioxide; Procedure: full conditioning; Drug: Ringer Lactate; Drug: Adept

Study type: Interventional

Funder types: Other

Identifiers

NCT01344499

S52808

Details and patient eligibility

About

Measurement of residual peritoneal fluid after laparoscopic surgery

Full description

Primary endpoints

• to evaluate whether the clearance rate of peritoneal fluid is exponential or linear over time. (absorption rate expected for Adept ~30-60 ml/h)
• to evaluate the role of the mesothelial barrier in this clearance rate.

Knowing that diffusion to and from peritoneal fluid decreases with increasing molecular weight (MW), our hypothesis is that clearance rate will decrease following peritoneal conditioning. Indeed a decreased mesothelial trauma (either through hypoxia or through denudation) and retraction will expose less the basal membrane

Secondary endpoints:

-To confirm the decrease in post-operative pain as measured by VAS-score and inflammation as measured by CRP and leucocytosis with the full conditioning of the pneumoperitoneum.

Enrollment: 20 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women planned to undergo a total or subtotal laparoscopic hysterectomy and having signed the informed consent.
• No limitation in body mass index or uterine size is made.

Exclusion criteria

• pregnancy
• immunodeficiency
• refuse or unable to sign informed consent
• chronic disease (i.e. COPD, Crohn, cardiac...)
• known allergy for Adept©

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Adept

Experimental group

Description:

1000ml Adept will be left in the abdomen and measured over time

Treatment:

Procedure: full conditioning

Procedure: Carbon dioxide

Drug: Adept

Ringer-lactate

Active Comparator group

Description:

1000 ml of Ringer lactate left in the abdomen and measured over time

Treatment:

Drug: Ringer Lactate

Procedure: full conditioning

Procedure: Carbon dioxide