PneumoperitoneumNCT05530564
Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in 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, Inflammatory Response
- 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
- 1 Jan 2020to 30 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 in Laparoscopic Cholecystectomy: A Prospective Randomized 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, Inflammatory Response
- Being tested
- low-pressure pneumoperitoneum, standard-pressure pneumoperitoneum
- Keywords
- Clinical trial, low pressure insufflation, pneumoperitoneum, laparoscopic cholecystectomy, pain, inflammatory marker
- Medical subject headings
- Pneumoperitoneum, Pain
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 pneumoperitoneum | 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 pneumoperitoneum | 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.
assessment of pain with SPS-11 at 6hr post-op
measure difference in pain on the 11-point short pain scale (SPS-11) at 6-hour post-op compared to baseline at pre-op, minimum score of 0 , maximun score of 10
= pain at 6 hour post op - pain at pre-op
Measured: pre-op to 6 hours post op
change in IL-6
measure differance of inflammatory marker from baseline
= baseline value- post op value (calculated in pg/mL) post-op collected at 24 hours from end of surgery
Measured: pre op to 24 hours post -op
Secondary outcomes (2)
assessment of difficulty of surgery
to measure difference in surgery difficulty between the two groups using a scale of 1; easy, 2; moderate, 3; difficult.
analysis done using Chi-square cross table on SPSS V 1.0.0.1406
Measured: start to end of the study, 1 year
assessment of difference in operation time
to look for difference in operation time between the two groups, calculated in minutes.
analysis done using Student's 2-tailed t-test on SPSS V 1.0.0.1406
Measured: start to end of the study, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jan 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- 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
- Treatment
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530564
- Sponsor's protocol ID
- 10/2019/1115
- Status last verified
- Sep 2022
- First submitted
- 27 Aug 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Reynolds W Jr. The first laparoscopic cholecystectomy. JSLS. 2001 Jan-Mar;5(1):89-94.
PubMed 11304004Soper NJ, Stockmann PT, Dunnegan DL, Ashley SW. Laparoscopic cholecystectomy. The new 'gold standard'? Arch Surg. 1992 Aug;127(8):917-21; discussion 921-3. doi: 10.1001/archsurg.1992.01420080051008.
PubMed 1386505Hypolito OH, Azevedo JL, de Lima Alvarenga Caldeira FM, de Azevedo OC, Miyahira SA, Miguel GP, Becker OM Jr, Machado AC, Nunes Filho GP, Azevedo GC. Creation of pneumoperitoneum: noninvasive monitoring of clinical effects of elevated intraperitoneal pressure for the insertion of the first trocar. Surg Endosc. 2010 Jul;24(7):1663-9. doi: 10.1007/s00464-009-0827-2. Epub 2009 Dec 25.
PubMed 20035347Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.
PubMed 26275545Gohil A. Comparison of low pressure versus standard pressure pneumoperitoneum for elective laparoscopic cholecystectomy in a tertiary care institute of western India. Int Surg J. 2018;5(5):1776. doi:10.18203/2349-2902.isj20181569
Celarier S, Monziols S, Francois MO, Assenat V, Carles P, Capdepont M, Fleming C, Rullier E, Napolitano G, Denost Q. Randomized trial comparing low-pressure versus standard-pressure pneumoperitoneum in laparoscopic colectomy: PAROS trial. Trials. 2020 Feb 22;21(1):216. doi: 10.1186/s13063-020-4140-7.
PubMed 32087762Bhattacharjee HK, Jalaludeen A, Bansal V, Krishna A, Kumar S, Subramanium R, Ramachandran R, Misra M. Impact of standard-pressure and low-pressure pneumoperitoneum on shoulder pain following laparoscopic cholecystectomy: a randomised controlled trial. Surg Endosc. 2017 Mar;31(3):1287-1295. doi: 10.1007/s00464-016-5108-2. Epub 2016 Jul 21.
PubMed 27444831Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
PubMed 20332509Neudecker J, Sauerland S, Neugebauer E, Bergamaschi R, Bonjer HJ, Cuschieri A, Fuchs KH, Jacobi Ch, Jansen FW, Koivusalo AM, Lacy A, McMahon MJ, Millat B, Schwenk W. The European Association for Endoscopic Surgery clinical practice guideline on the pneumoperitoneum for laparoscopic surgery. Surg Endosc. 2002 Jul;16(7):1121-43. doi: 10.1007/s00464-001-9166-7. Epub 2001 May 20.
PubMed 12015619Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.
PubMed 24503370Mandal A, Ghosh A, Bakshi S. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy: a comparative study. Int Surg J. 2020;7(5):1551. doi:10.18203/2349-2902.isj20201868
Mahajan S, Shankar M, Garg VK, Gupta V, Sorout J. Intraoperative safety of low pressure pneumoperitoneum cholecystectomy: a comparative study. Int Surg J. 2017;4(11):3679. doi:10.18203/2349-2902.isj20174885
Nasajiyan N, Javaherfourosh F, Ghomeishi A, Akhondzadeh R, Pazyar F, Hamoonpou N. Comparison of low and standard pressure gas injection at abdominal cavity on postoperative nausea and vomiting in laparoscopic cholecystectomy. Pak J Med Sci. 2014 Sep;30(5):1083-7. doi: 10.12669/pjms.305.5010.
PubMed 25225531Agarwal L, Kumawat S, Jain SA, Yadav A, Sharma S. Correlation of shoulder tip pain in case of low pressure and standard pressure pneumoperitoneum post laparoscopic cholecystectomy. Int Surg J. 2021;8(5):1522. doi:10.18203/2349-2902.isj20211820
Barczynski M, Herman RM. A prospective randomized trial on comparison of low-pressure (LP) and standard-pressure (SP) pneumoperitoneum for laparoscopic cholecystectomy. Surg Endosc. 2003 Apr;17(4):533-8. doi: 10.1007/s00464-002-9121-2. Epub 2003 Feb 17.
PubMed 12582754
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-pressure Pneumoperitoneum on Pain and Inflammation in Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05530564
- Acronym / sponsor ID
- 10/2019/1115
- Conditions
- Pneumoperitoneum, Pain, Inflammatory Response
- Keywords
- Clinical trial, low pressure insufflation, pneumoperitoneum, laparoscopic cholecystectomy, pain, inflammatory marker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 7 Sep 2022 (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
- Treatment
- 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 pneumoperitoneum | Experimental | Procedure: low-pressure pneumoperitoneumParticipants undergone laparoscopic cholecystectomy by creation of a low-pressure pneumoperitoneum, set at 8-10 mm Hg |
| Standard-pressure pneumoperitoneum | 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 pneumoperitoneum |
| standard-pressure pneumoperitoneuminsufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg | Procedure or surgery | Standard-pressure pneumoperitoneum |
Primary outcome
assessment of pain with SPS-11 at 6hr post-op
Time frame: pre-op to 6 hours post op
measure difference in pain on the 11-point short pain scale (SPS-11) at 6-hour post-op compared to baseline at pre-op, minimum score of 0 , maximun score of 10 = pain at 6 hour post op - pain at pre-op
change in IL-6
Time frame: pre op to 24 hours post -op
measure differance of inflammatory marker from baseline = baseline value- post op value (calculated in pg/mL) post-op collected at 24 hours from end of surgery
2 secondary outcomes
assessment of difficulty of surgery
Time frame: start to end of the study, 1 year
assessment of difference in operation time
Time frame: start to end of the study, 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 7 Sep 2022.
- Background: PubMed 11304004Reynolds W Jr. The first laparoscopic cholecystectomy. JSLS. 2001 Jan-Mar;5(1):89-94.
- Background: PubMed 1386505Soper NJ, Stockmann PT, Dunnegan DL, Ashley SW. Laparoscopic cholecystectomy. The new 'gold standard'? Arch Surg. 1992 Aug;127(8):917-21; discussion 921-3. doi: 10.1001/archsurg.1992.01420080051008.
- Background: PubMed 20035347Hypolito OH, Azevedo JL, de Lima Alvarenga Caldeira FM, de Azevedo OC, Miyahira SA, Miguel GP, Becker OM Jr, Machado AC, Nunes Filho GP, Azevedo GC. Creation of pneumoperitoneum: noninvasive monitoring of clinical effects of elevated intraperitoneal pressure for the insertion of the first trocar. Surg Endosc. 2010 Jul;24(7):1663-9. doi: 10.1007/s00464-009-0827-2. Epub 2009 Dec 25.
- Background: PubMed 26275545Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.
- BackgroundGohil A. Comparison of low pressure versus standard pressure pneumoperitoneum for elective laparoscopic cholecystectomy in a tertiary care institute of western India. Int Surg J. 2018;5(5):1776. doi:10.18203/2349-2902.isj20181569
- Background: PubMed 32087762Celarier S, Monziols S, Francois MO, Assenat V, Carles P, Capdepont M, Fleming C, Rullier E, Napolitano G, Denost Q. Randomized trial comparing low-pressure versus standard-pressure pneumoperitoneum in laparoscopic colectomy: PAROS trial. Trials. 2020 Feb 22;21(1):216. doi: 10.1186/s13063-020-4140-7.
- Background: PubMed 27444831Bhattacharjee HK, Jalaludeen A, Bansal V, Krishna A, Kumar S, Subramanium R, Ramachandran R, Misra M. Impact of standard-pressure and low-pressure pneumoperitoneum on shoulder pain following laparoscopic cholecystectomy: a randomised controlled trial. Surg Endosc. 2017 Mar;31(3):1287-1295. doi: 10.1007/s00464-016-5108-2. Epub 2016 Jul 21.
- Background: PubMed 20332509Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
- Background: PubMed 12015619Neudecker J, Sauerland S, Neugebauer E, Bergamaschi R, Bonjer HJ, Cuschieri A, Fuchs KH, Jacobi Ch, Jansen FW, Koivusalo AM, Lacy A, McMahon MJ, Millat B, Schwenk W. The European Association for Endoscopic Surgery clinical practice guideline on the pneumoperitoneum for laparoscopic surgery. Surg Endosc. 2002 Jul;16(7):1121-43. doi: 10.1007/s00464-001-9166-7. Epub 2001 May 20.
- Background: PubMed 24503370Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16.
- BackgroundMandal A, Ghosh A, Bakshi S. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy: a comparative study. Int Surg J. 2020;7(5):1551. doi:10.18203/2349-2902.isj20201868
- BackgroundMahajan S, Shankar M, Garg VK, Gupta V, Sorout J. Intraoperative safety of low pressure pneumoperitoneum cholecystectomy: a comparative study. Int Surg J. 2017;4(11):3679. doi:10.18203/2349-2902.isj20174885
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 7 Sep 2022. 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?
assessment of pain with SPS-11 at 6hr post-op (time frame: pre-op to 6 hours post op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05530564, which also lists 34 linked publications.
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 7 Sep 2022.