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Comparison of "Roll-over' Technique With Standard Abdominal Paracentesis in Suspected Peritoneal Carcinomatosis

NCT04232384 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2022-03-17

No results posted yet for this study

Summary

The study will be a randomized trial that will compare two techniques of abdominal paracentesis in patients with suspected peritoneal carcinomatosis. The patients will undergo abdominal paracentesis by the standard technique and a rollover technique. In the standard technique, the patients will lie flat for 10 minutes and abdominal paracentesis will be taken for ascitic fluid cytology. In the rollover group, patients with suspected peritoneal carcinomatosis will be rolled over thrice laterally on each side by 90 degrees and sample will then be obtained for ascitic fluid cytology. both the samples will be processed by blinded cytopathologist for tumour cellularity and diagnostic yield.

Conditions

  • Ascites
  • Peritoneal Carcinomatosis
  • Peritoneum Neoplasm
  • Tuberculous Peritonitis

Interventions

PROCEDURE

Standard Paracentesis

The patients will be asked to lie supine for 10 minutes and no changes in posture will be allowed for this period. Abdominal paracentesis will be done either by blind technique (in case the ascites is clinically detectable) or ultrasonography guided (in cases the ascites is not clinically detectable).

PROCEDURE

Roll Over Paracentesis

Patients with ascites will be rolled over thrice in bed laterally upto 90 degrees on either side (Figure 1) and ascitic fluid sample is drawn within 1 minute of the last rollover. There will be four steps to this i.e roll over to one side at 90 degrees and then 180 degrees to the other side, then back to the first side and then back to the center (to complete three turns). This will be done after the disinfection and cleaning of the anterior abdominal wall have been done and the personnel involved in the procedure are ready for the paracentesis. The ascitic paracentesis will be initiated within one minute of the completion of the turn. One assistant will maintain a stopwatch during this period to ensure compliance with this.

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Vishal Sharma, MD · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2021-07-01
Completion
2021-07-01

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04232384 on ClinicalTrials.gov