Outcome of Active Aspiration Versus Simple Compression to Remove Residual Gas From Abdominal Cavity in Reducing Pain After Laparoscopic Cholecystectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Edward Medical University

About this trial

The aim of this study is to compare outcome of active aspiration versus simple compression to remove residual gas from abdominal cavity in reducing pain after laparoscopic cholecystectomy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients of both genders.

Patients of age ≥ 18 years.

All patients presenting for elective laparoscopic cholecystectomy.

Disqualifiers

Patients suffering from obstructive jaundice anamnesis.

Patients who had received a diagnosis of gallbladder cancer.

Patients whose procedures were converted to open cholecystectomy during the surgery.

Patients who had additional pathologies such as bronchial asthma, chronic obstructive pulmonary disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Group A (Active Aspiration)

    Procedure/Surgery

    Once the trocars will be opened, aspiration cannula will be then placed through the accessory port reach at the subdiaphragmatic under direct visualization. After cessation of CO2 insufflation, residual gas will be removed by suctioning with 100 mmHg of pressure until the infra-diaphragmatic area of the abdominal wall close to liver surface. Negative pressure will be then ceased and the aspiration cannula will be taken out under direct vision. The procedure will be completed using the same method as the simple compression group.

  • simple compression

    Behavioral

    Active Gas Aspiration: Once the trocars will be opened, aspiration cannula will be then placed through the accessory port reach at the subdiaphragmatic under direct visualization. After cessation of CO2 insufflation, residual gas will be removed by suctioning with 100 mmHg of pressure until the infra-diaphragmatic area of the abdominal wall close to liver surface. Negative pressure will be then ceased and the aspiration cannula will be taken out under direct vision. The procedure will be completed using the same method as the simple compression group.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Group B (Simple compression)Placebo comparator 1 intervention
Group B: Group A (Active gas aspiration)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numerical Pain Intensity Scale (NPIS)

The Numerical Pain Intensity Scale (NPIS) is a simple, self-reported tool commonly used in clinical settings to assess the intensity of a person's pain. It typically ranges from 0 to 10, with 0 indicating "no pain" and 10 representing "the worst pain imaginable." Patients are asked to rate their pain based on their current experience, providing healthcare professionals with a clear indication of the pain's severity. This scale is useful for tracking pain changes over time, evaluating the effectiveness of treatments, and facilitating communication between patients and providers about pain management. The NPIS is valued for its ease of use and ability to provide quick, quantifiable insights into a patient's pain level.

Time frame
24 hours

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: