---
title: Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum
nct_id: NCT01344499
overall_status: COMPLETED
phase: NA
sponsor: University Hospital, Gasthuisberg
study_type: INTERVENTIONAL
primary_condition: Laparoscopic Hysterectomy
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01344499.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01344499"
ct_last_update_post_date: 2013-06-04
last_seen_at: "2026-05-12T07:24:44.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clearance Rate of Peritoneal Fluid After Full Conditioning Pneumoperitoneum

**Official Title:** Clearance Rate of Peritoneal Fluid Assessed by Post-operative Ultrasound Decreases After Full Conditioning Pneumoperitoneum

**NCT ID:** [NCT01344499](https://clinicaltrials.gov/study/NCT01344499)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** University Hospital, Gasthuisberg
- **Conditions:** Laparoscopic Hysterectomy
- **Start Date:** 2009-08
- **Completion Date:** 2011-09
- **CT.gov Last Update:** 2013-06-04

## Brief Summary

Measurement of residual peritoneal fluid after laparoscopic surgery

## Detailed 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.

## Eligibility

- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
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©
```

## Arms

- **Adept** (EXPERIMENTAL) — 1000ml Adept will be left in the abdomen and measured over time
- **Ringer-lactate** (ACTIVE_COMPARATOR) — 1000 ml of Ringer lactate left in the abdomen and measured over time

## Interventions

- **Carbon dioxide** (PROCEDURE) — standard pneumoperitoneum with 100% CO2
- **full conditioning** (PROCEDURE) — Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
- **Adept** (DRUG) — instillation of 1 liter of fluid at the end of laparoscopy
- **Ringer Lactate** (DRUG) — instillation of 1 liter of fluid at the end of laparoscopy

## Primary Outcomes

- **clearance rate of peritoneal fluid** _(time frame: 3 days after surgery)_ — We will estimate the residual volume of fluid in the abdominal cavity in a 30° anti-Trendelenburg position after 1 minute in this position. Measurements will be repeated daily until discharge.

## Secondary Outcomes

- **Pain and inflammation score** _(time frame: 3 days after surgery)_

## Locations (1)

- UZ Leuven, campus Gasthuisberg, Leuven, Belgium

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.uz leuven, campus gasthuisberg|leuven||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01344499.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01344499*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*