Cholecystitis/CholelithiasisPOPLOPNCT04670952
Potential Pulmonary Benefit of Low Pressure Laparoscopic Cholecystectomy in Selected Patients
A study testing Low Pressure Laparoscopic Cholecystectomy and Standard Pressure Laparoscopic Cholecystectomy in people with Cholecystitis/Cholelithiasis and Cholecystitis; Gallstone, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Standard Pressure Laparoscopic Cholecystectomy，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis. According to literature, low pressure laparoscopic cholecystectomy is thought to probably decrease cardio-pulmonary related complications and postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cholecystitis/Cholelithiasis, Cholecystitis; Gallstone, Polyp Gallbladder
- What is being tested?
- Low Pressure Laparoscopic Cholecystectomy and Standard Pressure Laparoscopic Cholecystectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2019to Dec 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-85;
- Patients receiving laparoscopic cholecystectomy due to benign gallbladder diseases;
- Older patient or accompanied by cardiopulmonary diseases (age>60 years, hypertension, Diabetes Mellitus, coronary heart disease, arrhythmia, chronic bronchitis, emphysema, history of heart surgery, history of lung surgery, history of mediastinal surgery, asthma, et al);
- Aged older than 60, with or without the above diseases;
- American society of Aneshesiologists (ASA) II or higher;
- Informed consent acquired.
Who cannot join
- Having contraindication of laparoscopic operations;
- History at epigastric surgery. -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Hui Xu, Docor, +86-01069156874, pumchkyc@126.com
Feng Tian, Doctor
About this study
Official title: The Pulmonary Effects of Low Pressure Versus Standard Pressure Laparoscopic Cholecystectomy in Patients With Cardiopulmonary Disorders: A Prospective Randomized Controlled Trial
Standard Pressure Laparoscopic Cholecystectomy，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis. According to literature, low pressure laparoscopic cholecystectomy is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, the previous studies have presented controversial results. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.
Read the detailed description
Standard Pressure Laparoscopic Cholecystectomy, SPLC；12-16mmHg，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis.
According to literature, Low Pressure Laparoscopic Cholecystectomy, LPLC；8-10mmHg is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, most of the existing study have combined population with all age scale, bringing bias to the result. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.
- Being tested
- Low Pressure Laparoscopic Cholecystectomy, Standard Pressure Laparoscopic Cholecystectomy
- Keywords
- low pressure; laparoscopic cholecystectomy
- Medical subject headings
- Cholecystitis, Cholelithiasis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Pressure Laparoscopic CholecystectomyOther
Low Pressure Laparoscopic Cholecystectomy (10mmHg) is set as the experimental group.
Standard Pressure Laparoscopic CholecystectomyOther
Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group.
| Study group | Role | What they receive |
|---|---|---|
| Low Pressure Laparoscopic Cholecystectomy | Experimental | LPLC refers to "Low Pressure Laparoscopic Cholecystectomy". In this arm, the pneumoperitoneum pressure is set as 10mmHg. Receives: Other: Low Pressure Laparoscopic Cholecystectomy |
| Standard Pressure Laparoscopic Cholecystectomy | Other | This is taken as the control group. SPLC refers to "Standard Pressure Laparoscopic Cholecystectomy". In this arm, the pneumoperitoneum pressure is set as 14 mmHg. Receives: Other: Standard Pressure Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of partial pressure of carbon dioxide（pCO2）
Change of pCO2 in arterial blood gas test
Measured: Within postoperative 30 days.
Secondary outcomes (4)
operation time
skin to skin operative duration
Measured: During surgery.
conversion rate to open surgery
Need of conversion to open surgery duo to adhesion, hemorrhage, or other reasons.
Measured: During surgery.
visual analogue scale (VAS)
For evaluation of postoperative pain degree, using VAS, scoring 1-10 scores.
Measured: During postoperative 24 hours.
complication rate
Rate of total postoperative complications
Measured: Within postoperative 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start10 Jun 2019
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis/CholelithiasisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Tian, Peking Union Medical College Hospital
- Investigators
- Xiaodong He, Doctor, Study director, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670952
- Sponsor's protocol ID
- Feng Tian
- Acronym
- POPLOP
- Status last verified
- Dec 2020
- First submitted
- 24 Nov 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tian F, Sun X, Yu Y, Zhang N, Hong T, Liang L, Yao B, Song L, Pei C, Wang Y, Lu W, Qu Q, Guo J, Zhang T, He X. Comparison of low-pressure and standard-pressure pneumoperitoneum laparoscopic cholecystectomy in patients with cardiopulmonary comorbidities: a double blinded randomized clinical trial. BMC Surg. 2024 Nov 6;24(1):348. doi: 10.1186/s12893-024-02606-w.
PubMed 39506748
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pulmonary Effects of Low Pressure Versus Standard Pressure Laparoscopic Cholecystectomy in Patients With Cardiopulmonary Disorders: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04670952
- Acronym / sponsor ID
- POPLOP / Feng Tian
- Keywords
- low pressure; laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Dec 2020 (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.
Standard Pressure Laparoscopic Cholecystectomy，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis. According to literature, low pressure laparoscopic cholecystectomy is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, the previous studies have presented controversial results. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.
Detailed description
Standard Pressure Laparoscopic Cholecystectomy, SPLC；12-16mmHg，as the standard for cholecystectomy, can lead to about 15% of pulmonary atelectasis.
According to literature, Low Pressure Laparoscopic Cholecystectomy, LPLC；8-10mmHg is thought to probably decrease cardio-pulmonary related complications and postoperative pain. However, most of the existing study have combined population with all age scale, bringing bias to the result. Our study aim to evaluate the potential pulmonary benefit of low pressure laparoscopic cholecystectomy in elderly or patients accompanied with cardio-pulmonary disorders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Pressure Laparoscopic Cholecystectomy | Experimental | Other: Low Pressure Laparoscopic CholecystectomyLPLC refers to "Low Pressure Laparoscopic Cholecystectomy". In this arm, the pneumoperitoneum pressure is set as 10mmHg. |
| Standard Pressure Laparoscopic Cholecystectomy | Other | Other: Standard Pressure Laparoscopic CholecystectomyThis is taken as the control group. SPLC refers to "Standard Pressure Laparoscopic Cholecystectomy". In this arm, the pneumoperitoneum pressure is set as 14 mmHg. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-85;
- Patients receiving laparoscopic cholecystectomy due to benign gallbladder diseases;
- Older patient or accompanied by cardiopulmonary diseases (age>60 years, hypertension, Diabetes Mellitus, coronary heart disease, arrhythmia, chronic bronchitis, emphysema, history of heart surgery, history of lung surgery, history of mediastinal surgery, asthma, et al);
- Aged older than 60, with or without the above diseases;
- American society of Aneshesiologists (ASA) II or higher;
Key exclusion criteria (2 listed)
- Having contraindication of laparoscopic operations;
- History at epigastric surgery. -
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 Laparoscopic CholecystectomyLow Pressure Laparoscopic Cholecystectomy (10mmHg) is set as the experimental group. | Other | Low Pressure Laparoscopic Cholecystectomy |
| Standard Pressure Laparoscopic CholecystectomyStandard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group. | Other | Standard Pressure Laparoscopic Cholecystectomy |
Primary outcome
Change of partial pressure of carbon dioxide（pCO2）
Time frame: Within postoperative 30 days.
Change of pCO2 in arterial blood gas test
4 secondary outcomes
operation time
Time frame: During surgery.
conversion rate to open surgery
Time frame: During surgery.
visual analogue scale (VAS)
Time frame: During postoperative 24 hours.
complication rate
Time frame: Within postoperative 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Derived from this study: PubMed 39506748Tian F, Sun X, Yu Y, Zhang N, Hong T, Liang L, Yao B, Song L, Pei C, Wang Y, Lu W, Qu Q, Guo J, Zhang T, He X. Comparison of low-pressure and standard-pressure pneumoperitoneum laparoscopic cholecystectomy in patients with cardiopulmonary comorbidities: a double blinded randomized clinical trial. BMC Surg. 2024 Nov 6;24(1):348. doi: 10.1186/s12893-024-02606-w.
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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.
Xiaodong He, Doctor study director
Peking Union Medical College Hospital
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 Laparoscopic Cholecystectomy and Standard Pressure Laparoscopic Cholecystectomy in people with Cholecystitis/Cholelithiasis and Cholecystitis; Gallstone, run by Peking Union Medical College Hospital at 1 site in China.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Dec 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Tian, Doctor (+86-01069152600, andytianfeng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of partial pressure of carbon dioxide（pCO2） (time frame: Within postoperative 30 days.). 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 NCT04670952, which also lists 1 linked publication.
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 23 Dec 2020.