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In-Vivo Sonographic Detection of Free Intra-Abdominal Fluid in Humans: A Prospective Study on FAST Detection Rates with Sequential Fluid Instillation

In-Vivo Sonographic Detection of Free Intra-Abdominal Fluid in Humans: A Prospective Study on FAST Detection Rates with Sequential Fluid Instillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038199
Enrollment
93
Registered
2025-10-30
Start date
2020-11-02
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Free intra-abdominal fluid

Interventions

Group 1: Sequential Fluid Instillation and FAST Examination (In-vivo) During elective laparoscopic procedures, defined volumes of 0.9 % saline (250 ml, 500 ml, 1000 ml, 1500 ml) are sequentially insti

Sponsors

Bundeswehrzentralkrankenhaus Koblenz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age = 18 years (adult participants) Written informed consent obtained prior to participation Scheduled elective laparoscopic procedure under general anaesthesia Normal intra-abdominal anatomy (no major previous abdominal surgery) Feasibility of standardised FAST examination in the supine position No contraindications to intraperitoneal instillation of 0.9 % NaCl

Exclusion criteria

Exclusion criteria: Anatomical alterations of the abdominal cavity (e.g. splenectomy, extended liver resection, hysterectomy, cystectomy, prostatectomy) Obesity grade II or higher (BMI = 35 kg/m²) Pregnancy Presence of follicular or ovarian cysts Acute intra-abdominal inflammation or infection Contraindications to the use of 0.9 % NaCl Refusal to participate or inability to provide informed consent

Design outcomes

Primary

MeasureTime frame
Sensitivity of the FAST (Focused Assessment with Sonography for Trauma) examination for detecting free intra-abdominal fluid depending on the instilled volume.

Secondary

MeasureTime frame
Specificity of the FAST examination Proportion of correctly negative FAST findings at 0 ml of intraperitoneal fluid (baseline). Time point: Before the first fluid instillation. Comparison of detection rates between anatomical regions Comparison of sensitivity across Morison’s pouch, pouch of Douglas (transverse and longitudinal planes), and splenorenal recess. Statistical analysis: One-way ANOVA. Influence of body mass index (BMI) on detection rate Subgroup analysis according to BMI categories (< 25, 25–29.9, = 30 kg/m²). Outcome measure: Change in sensitivity across BMI groups. Effect of scan orientation (transverse vs. longitudinal) in the pouch of Douglas Comparison of detection rates depending on the chosen scanning plane. Outcome measure: Difference in percentage detection rate. Minimal detectable fluid volume (detection threshold) Determination of the fluid volume (ml) at which = 50% of FAST examinations become positive (threshold analysis). Correlation between detection rate and examiner experience Exploratory analysis by examiner experience (= 5 years vs. less experienced operators, if applicable). Influence of previous abdominal surgery on detection rate Comparison of participants with and without prior abdominal surgery.

Countries

Germany

Contacts

Public ContactSebastian Schaaf

Bundeswehrzentralkrankenhaus Koblenz

sebastianschaaf@bundeswehr.org+4926128222810

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026