Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post Laparoscopic Cholecystectomy

NCT04779515 | Completed DMC

• 1 other identifier: 2243
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of low-pressure pneumoperitoneum on post operative pain and inflammation in patients undergoing elective laparoscopic cholecystectomy by comparing it to standard practice.

Conditions

Pneumoperitoneum; Pain; Inflammation

Keywords

low-pressure pneumoperitoneum, lap chole

Outcome Measures

Primary Outcomes (13)

• change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 12 post-op

  the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at 12-hr post-op) - (baseline pain score assessed at 6-hr post-op)

  baseline and 12 hours post-op

• change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 24 post-op

  the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at 24-hr post-op) - (baseline pain score assessed at 6-hr post-op)

  baseline and 24 hours post-op

• change from baseline in pain on the 11-point short pain scale (SPS-11) at day 7 post-op

  the SPS-11 is a validated, self-reported numeric instrument assessing pain intensity, ranging from 0 to 10; where 0 is no pain, and 10 is the worst pain felt ever. change = (pain score at post-op day 7) - (baseline pain score assessed at 6-hr post-op)

  baseline and 7 days post-op

• change from baseline in WBC count at 24hr post op

  calculate the rise in white blood cycles count as inflammatory marker post-op in 1000 cells per cubic millimeter of blood. change = (post-op WBC count) - (baseline WBC count)

  baseline and 24 hours post-op

• change from baseline in Plt count at 24hr post op

  calculate the rise in platelets count as inflammatory marker post-op in × 10\^9/L of blood change = (post-op Plt count) - (baseline Plt count)

  baseline and 24 hours post-op

• change from baseline in ESR value at 24hr post op

  calculate the rise in erythrocyte sedimentation rate value as inflammatory marker post-op in millimeters per hour. change = (post-op ESR) - (baseline ESR)

  baseline and 24 hours post-op

• change from baseline in CRP level at 24hr post op

  calculate the rise in C reactive protein level as inflammatory marker post-op in mg/L change = (post-op CRP) - (baseline CRP)

  baseline and 24 hours post-op

• change from baseline in Alb level at 24hr post op

  calculate the drop in albumin level as inflammatory marker post-op in g/dL change = (baseline Alb) - (post-op baseline Alb)

  baseline and 24 hours post-op

• change from baseline in cortisol level at 4hr post op

  calculate the rise in cortisol level as inflammatory marker post-op in nmol/L change = (post-op cortisol ) - (baseline cortisol )

  baseline and 4 hours post-op

• change from baseline in IL-6 level at 24hr post op

  calculate the rise in interleukin 6 level as inflammatory marker post-op in pg/mL change = (post-op IL-6) - (baseline IL-6)

  baseline and 24 hours post-op

• change from baseline in IL-17 level at 24hr post op

  calculate the rise in interleukin 17 level as inflammatory marker post-op in pg/mL change = (post-op IL-17) - (baseline IL-17)

  baseline and 24 hours post-op

• change from baseline in IL-1 level at 24hr post op

  calculate the rise in interleukin 1 level as inflammatory marker post-op in pg/mL change = (post-op IL-1) - (baseline IL-1)

  baseline and 24 hours post-op

• change from baseline in TNF level at 24hr post op

  calculate the rise in tumor necrosis factor alpha level as inflammatory marker post-op in pg/mL change = (post-op TNF) - (baseline TNF)

  baseline and 24 hours post-op

Secondary Outcomes (2)

• Difference in surgery difficulty level among two groups

  through study completion, an average of 1 year

• Difference in surgery time among two groups

  through study completion, an average of 1 year

Study Arms (2)

Low-pressure

EXPERIMENTAL

Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg

Procedure: low-pressure pneumoperitoneum

Standard-pressure

ACTIVE COMPARATOR

Participants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg

Procedure: standard-pressure pneumoperitoneum

Interventions

low-pressure pneumoperitoneum PROCEDURE

insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg

Low-pressure

standard-pressure pneumoperitoneum PROCEDURE

insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg

Standard-pressure

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective admission for laparoscopic cholecystectomy

You may not qualify if:

• Current or previous diagnosis of acute cholecystitis confirmed by ultrasound
• previous GI surgeries, except bariatric and anti-reflux surgeries
• Currently on immunosuppressant agents
• Pregnancy
• Breastfeeding
• Currently diagnosed with drug addiction
• American Society of Anesthesiologists (ASA) score 3 and more

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, Jubaiha, 13046, Jordan

Location

MeSH Terms

Conditions

Pneumoperitoneum; Pain; Inflammation

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Salam Daradkeh, Prof.

  University of Jordan

  STUDY CHAIR

• Mohammad Rashdan, Prof.

  University of Jordan

  PRINCIPAL INVESTIGATOR

• Raed Al-Taher, Prof.

  University of Jordan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: none of the participants knew at which pressure they will be operated on, nor the physicians who followed participants at floor or those analyzing blood samples, not the assigned physician to collect data, nor the personnel doing the analysis. only the operating surgeon and circulating nurse were aware of the meaning of the participant assigned label at time of operation. The masking was revealed post completion of analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hanan Mansour, post-graduate, general surgery resident

Model Details: participants were divided into two masked groups, labelled red and green; those operated at low-pressure pneumoperitoneum (green-label) and those operated at standard-pressure pneumoperitoneum (red-label).

Study Record Dates

• First Submitted: February 27, 2021
• First Posted: March 3, 2021
• Study Start: January 20, 2020
• Primary Completion: January 22, 2021
• Study Completion: January 22, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: the data will be available from April,2021 up to the end of 2021 year
• Access Criteria: Data will be shared for medical investigators interested in the topic of pneumoperitoneum, to request please contact (hanan.ju@gmail.com)

Locations

JO (1)