PneumoperitoneumNCT04779515
Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post Laparoscopic Cholecystectomy
A study testing low-pressure pneumoperitoneum and standard-pressure pneumoperitoneum in people with Pneumoperitoneum and Pain, run by University of Jordan at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pneumoperitoneum, Pain, Inflammation
- What is being tested?
- low-pressure pneumoperitoneum and standard-pressure pneumoperitoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 20 Jan 2020to 22 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elective admission for laparoscopic cholecystectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post Laparoscopic Cholecystectomy: A Randomized, Double-blinded, Controlled, Clinical Trial.
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.
Read the detailed description
After obtaining informed consent from eligible study participants. patients were randomized into one of two masked groups, labelled red and green. The red-label group was operated at standard-pressure pneumoperitoneum, while the green-label group was operated at low-pressure pneumoperitoneum. Baseline blood samples were obtained pre-operatively for ten inflammatory markers, patients' demographics and intra-operative details collected, then post-operative pain and change in inflammatory markers were followed.
- Conditions
- Pneumoperitoneum, Pain, Inflammation
- Being tested
- low-pressure pneumoperitoneum, standard-pressure pneumoperitoneum
- Keywords
- low-pressure pneumoperitoneum, lap chole
- Medical subject headings
- Pneumoperitoneum, Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-pressure pneumoperitoneumProcedure or surgery
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
standard-pressure pneumoperitoneumProcedure or surgery
insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg
| Study group | Role | What they receive |
|---|---|---|
| Low-pressure | Experimental | Participants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg Receives: 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 Receives: Procedure: standard-pressure pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 )
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline and 24 hours post-op
Secondary outcomes (2)
Difference in surgery difficulty level among two groups
assessing level of surgery difficulty between low and standard pressure pneumoperitoneum groups.
Difficulty was self reported by operating surgeon as easy (score=1), moderate (score=2), or difficult (score=3).
Difference assessed by calculating average between groups
Measured: through study completion, an average of 1 year
Difference in surgery time among two groups
assessing difference in insufflation time calculated in minutes between low and standard pressure pneumoperitoneum groups.
insufflation time was calculated from time of creation of pneumoperitoneum to deflation of the abdomen.
Difference assessed by calculating average between groups
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start20 Jan 2020
- Primary completion22 Jan 2021
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoperitoneumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Ibrahim Mansour, University of Jordan
- Investigators
- Salam Daradkeh, Prof., Study chair, University of JordanMohammad Rashdan, Prof., Principal investigator, University of JordanRaed Al-Taher, Prof., Study director, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779515
- Sponsor's protocol ID
- 2243
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we are willing to share all study data for interested researchers to conduct secondary studies of their own.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation Post Laparoscopic Cholecystectomy: A Randomized, Double-blinded, Controlled, Clinical Trial.
- ClinicalTrials.gov ID
- NCT04779515
- Acronym / sponsor ID
- 2243
- Conditions
- Pneumoperitoneum, Pain, Inflammation
- Keywords
- low-pressure pneumoperitoneum, lap chole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After obtaining informed consent from eligible study participants. patients were randomized into one of two masked groups, labelled red and green. The red-label group was operated at standard-pressure pneumoperitoneum, while the green-label group was operated at low-pressure pneumoperitoneum. Baseline blood samples were obtained pre-operatively for ten inflammatory markers, patients' demographics and intra-operative details collected, then post-operative pain and change in inflammatory markers were followed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Low-pressure | Experimental | Procedure: low-pressure pneumoperitoneumParticipants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg |
| Standard-pressure | Active comparator | Procedure: standard-pressure pneumoperitoneumParticipants undergone laparoscopic cholecystectomy by creation of a standard-pressure pneumoperitoneum, set at 12-14 mm Hg |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Elective admission for laparoscopic cholecystectomy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-pressure pneumoperitoneuminsufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg | Procedure or surgery | Low-pressure |
| standard-pressure pneumoperitoneuminsufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg | Procedure or surgery | Standard-pressure |
Primary outcome
change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 12 post-op
Time frame: baseline and 12 hours 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)
change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 24 post-op
Time frame: baseline and 24 hours 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)
change from baseline in pain on the 11-point short pain scale (SPS-11) at day 7 post-op
Time frame: baseline and 7 days 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)
change from baseline in WBC count at 24hr post op
Time frame: baseline and 24 hours 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)
change from baseline in Plt count at 24hr post op
Time frame: baseline and 24 hours 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)
change from baseline in ESR value at 24hr post op
Time frame: baseline and 24 hours 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)
change from baseline in CRP level at 24hr post op
Time frame: baseline and 24 hours post-op
calculate the rise in C reactive protein level as inflammatory marker post-op in mg/L change = (post-op CRP) - (baseline CRP)
change from baseline in Alb level at 24hr post op
Time frame: baseline and 24 hours post-op
calculate the drop in albumin level as inflammatory marker post-op in g/dL change = (baseline Alb) - (post-op baseline Alb)
change from baseline in cortisol level at 4hr post op
Time frame: baseline and 4 hours post-op
calculate the rise in cortisol level as inflammatory marker post-op in nmol/L change = (post-op cortisol ) - (baseline cortisol )
change from baseline in IL-6 level at 24hr post op
Time frame: baseline and 24 hours 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)
change from baseline in IL-17 level at 24hr post op
Time frame: baseline and 24 hours 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)
change from baseline in IL-1 level at 24hr post op
Time frame: baseline and 24 hours 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)
change from baseline in TNF level at 24hr post op
Time frame: baseline and 24 hours 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)
2 secondary outcomes
Difference in surgery difficulty level among two groups
Time frame: through study completion, an average of 1 year
Difference in surgery time among two groups
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Individual participant dataSharing planned: Yes. we are willing to share all study data for interested researchers to conduct secondary studies of their own.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salam Daradkeh, Prof. study chair
University of Jordan
Mohammad Rashdan, Prof. principal investigator
University of Jordan
Raed Al-Taher, Prof. study director
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-pressure pneumoperitoneum and standard-pressure pneumoperitoneum in people with Pneumoperitoneum and Pain, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in pain on the 11-point short pain scale (SPS-11) at hour 12 post-op (time frame: baseline and 12 hours post-op). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.