CholecystectomyNCT06447545
Comparison Between Low Pressure Pneumoperitoneum with High Pressure Pneumoperitoneum in Post-operative Pain, Shoulder Tip Pain and Common Bile Duct Injuries in Patients Undergoing Laparoscopic Cholecystectomy
A study testing Changing pressure of Pneumoperitoneum to 6-10 mmHg and Changing pressure of Pneumoperitoneum to 12-15 mmHg in people with Cholecystectomy and Pneumoperitoneum, run by Gulab Devi Hospital at 1 site in Pakistan.
Trial summary
This study aims to address the existing gap in knowledge by conducting a comprehensive comparison of the incidence of pain and common bile duct injuries in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum versus high pressure pneumoperitoneum. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholecystectomy, Pneumoperitoneum, Pain, Postoperative
- What is being tested?
- Changing pressure of Pneumoperitoneum to 6-10 mmHg and Changing pressure of Pneumoperitoneum to 12-15 mmHg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 19 May 2024to 30 Nov 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients from both genders
- Patients undergoing laparoscopic cholecystectomy for cholelithiasis.
Who cannot join
- Patients with cardiac abnormalities.
- Patients with previous abdominal surgeries.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Gulab Devi Hospital
Lahore, PUN, 54000
M. Zia-ul-Miraj Ahmad, MBBS,FRCS, +92-42-35918040 ext. 3091-3100, alaleemmc@gmail.com
About this study
This study aims to address the existing gap in knowledge by conducting a comprehensive comparison of the incidence of pain and common bile duct injuries in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum versus high pressure pneumoperitoneum.
Read the detailed description
Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder. It helps people when gallstones cause inflammation, pain or infection. Since the early 1990s, the laparoscopic cholecystectomy technique has largely supplanted the open approach for routine gallbladder removal. This method is recommended for various conditions such as cholecystitis (both acute and chronic), symptomatic cholelithiasis, biliary dyskinesia, acalculous cholecystitis, gallstone pancreatitis, and gallbladder masses/polyps-similar to the indications for an open cholecystectomy. Gallbladder cancers, however, are typically better addressed through open cholecystectomy. In the United States, around 20 million people have gallstones, leading to approximately 300,000 cholecystectomies annually. Ten to fifteen percent of the population has asymptomatic gallstones, and among them, 20% experience symptoms such as biliary colic. Complications, including acute cholecystitis, gallstone pancreatitis, choledocholithiasis, and gallstone ileus, manifest in approximately 1% to 4% of symptomatic cases. Gallstone prevalence increases with age, with women between 50 to 65 years having a 20% incidence, compared to 5% in men. Cholesterol constitutes 75% of gallstones, while the remaining 25% are pigmented; however, clinical signs and symptoms remain consistent regardless of the gallstone composition.1 Low-pressure and high-pressure pneumoperitoneum, both integral to laparoscopic cholecystectomy, have been subjects of extensive research, primarily focusing on their impact on post-operative pain management.
Traditionally, in laparoscopic cholecystectomy, one of the initial procedures involves creating pneumoperitoneum. This is done by introducing carbon dioxide (CO2) either through a veress needle or a port in the abdominal wall. The CO2 is then gently infused into the peritoneal cavity, reaching a pressure of 10-20 mmHg, at a rate of 4-6 litres per minute. To maintain the pneumoperitoneum, a steady gas flow of 200-400 ml/min is sustained. In conventional laparoscopic cholecystectomy, a higher intra-abdominal pressure of 12-15mmHg is used, while low-pressure pneumoperitoneum laparoscopic cholecystectomy employs pressures below 8mmHg.2 High-pressure pneumoperitoneum, involving insufflation pressures typically ranging from 12 to 15 mmHg or higher, facilitates enhanced intraoperative visualization, ease of surgical manipulation, and shorter operative times. However, despite these advantages, it commonly correlates with increased post-operative pain and discomfort, particularly in the form of referred shoulder pain. The mechanism behind this pain is attributed to diaphragmatic irritation and irritation of the phrenic nerve due to the increased pressure within the peritoneal cavity.3 In contrast, low-pressure pneumoperitoneum, characterized by lower insufflation pressures, often ranging from 8 to 12 mmHg, aims to mitigate the post-operative discomfort experienced by patients. Studies exploring the use of lower pressures have indicated promising outcomes in reducing post-operative pain levels, shoulder discomfort, and overall patient discomfort following laparoscopic cholecystectomy.4 Although low-pressure pneumoperitoneum may potentially prolong the operative duration due to decreased visibility and the need for more delicate surgical manoeuvres, it presents a viable option for patients prone to experiencing heightened post-operative pain. The advantages of decreased pain, reduced shoulder discomfort, and potentially faster recovery post-surgery make low-pressure pneumoperitoneum an appealing consideration, especially for patients with a lower threshold for pain or those with a history of difficulties in managing post-operative discomfort. According to recent study pain was experienced in 22.5 % in Low pressure vs 57% in high pressure pneumoperitoneum technique 5,6
Bile duct injury (BDI) following cholecystectomy, particularly laparoscopic cholecystectomy (LC), is indeed a serious complication associated with significant morbidity and mortality. The incidence of BDI has increased with the adoption of laparoscopic techniques. The complications often result from anatomical misperceptions or inadvertent dissection, leading to injury to the common bile duct (CBD). Several factors contribute to the increased incidence of BDI in LC compared to open cholecystectomy. These include disorientation of anatomical variables, inadvertent dissection at Calot's triangle, or visual misperception by the operating surgeon. Proximal injuries, occurring within 2cm from the bifurcation, are becoming more prevalent. Recognition of CBD injury is crucial for prompt and effective management, as delayed diagnosis can lead to severe complications such as systemic inflammatory response syndrome and multi-organ failure syndrome. The time of presentation of these injuries can vary, making early detection challenging. Preventing common bile duct injury involves several key principles:
- Optimal Exposure of Calot's Triangle: Proper exposure of Calot's triangle allows the surgeon to visualize the anatomical structures clearly, reducing the risk of inadvertent injury.
- Judicious Use of Diathermy Near CBD Territory: Careful use of diathermy (electrosurgery) near the CBD is essential to avoid thermal injury. Excessive use of diathermy can lead to tissue damage and increase the risk of bile duct injury.
- Use of a 30-Degree Telescope: A 30-degree laparoscope provides a better angle of vision, enhancing the surgeon's ability to visualize anatomical structures accurately during laparoscopic procedures.
- Safe Clip Application without Tenting of CBD: Applying clips to secure structures without tenting the CBD helps avoid compression and potential injury. Proper clip placement is crucial for securing structures while minimizing the risk of damage to nearby tissues.
- Adherence to the Rule of Thumb: Surgeons should be mindful of the "rule of thumb" to prevent common bile duct injury. This involves meticulous and precise surgical technique, including gentle tissue handling and avoiding excessive traction on the structures.
In conclusion, preventing common bile duct injury during cholecystectomy requires a combination of technical skill, anatomical knowledge, and adherence to established principles. Surgeons must be vigilant and adopt a cautious approach to minimize the risk of this serious complication. Early recognition and active management of CBD injuries are essential for improving patient outcomes and reducing morbidity and mortality associated with this iatrogenic catastrophe7.
The choice between these techniques involves a careful consideration of multiple factors, including the specific characteristics of the patient, the surgeon's expertise, and the complexities of the surgical procedure. As medical practitioners continue to explore ways to enhance patient outcomes and minimize post-operative discomfort, the debate between low-pressure and high-pressure pneumoperitoneum in laparoscopic cholecystectomy remains an active area of research and clinical consideration.
- Conditions
- Cholecystectomy, Pneumoperitoneum, Pain, Postoperative
- Being tested
- Changing pressure of Pneumoperitoneum to 6-10 mmHg, Changing pressure of Pneumoperitoneum to 12-15 mmHg
- Medical subject headings
- Pneumoperitoneum, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changing pressure of Pneumoperitoneum to 6-10 mmHgDevice
Also called Low Pressure Pneumoperitoneum
Result of changing pneumoperitoneum pressure on CBD injury and pain
Changing pressure of Pneumoperitoneum to 12-15 mmHgDevice
Also called High Pressure Pneumoperitoneum
Result of changing pneumoperitoneum pressure on CBD injury and pain
| Study group | Role | What they receive |
|---|---|---|
| Low Pressure Pneumoperitoneum | Other | low-pressure pneumoperitoneum in which the pressure is (6-10 mmHg) Receives: Device: Changing pressure of Pneumoperitoneum to 6-10 mmHg |
| High Pressure Pneumoperitoneum | Other | High-pressure pneumoperitoneum, involving insufflation pressures typically ranging from 12 to 15 mmHg or higher Receives: Device: Changing pressure of Pneumoperitoneum to 12-15 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of pain and common bile duct injury in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum is less versus High pressure pneumoperitoneum.
Pain will accessed using VAS. Pain (VAS): The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). It was assessed at 4, 8, 12 hours post-operatively by using Visual Analogue Pain Scale.
No pain |0____1____2____3____4____5____6____7____8____9____10| sever pain Mild pain-Moderate Pain-Sever pain Visual Analogue Pain Scale And CBD injury will be accessed using bismuth classification.
CBD INJURY: Injury to CBD Is Classified According to Bismuth Classification:
Type I is a low injury with a stump length more than 2 cm. Type II is a middle level injury with a stump length less than 2 cm. Type III is a high-level injury without common hepatic duct available but preserved confluence.
Type IV involves loss of hepatic confluence with no communication between right and left ducts.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start19 May 2024
- Primary completion19 May 2024
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulab Devi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zain Himayoun, University of Health Sciences Lahore
- Investigators
- M. Zia-ul-Miraj Ahmad, MBBS,FRCS, Study director, Gulab Devi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447545
- Sponsor's protocol ID
- AAMC/IRB/EA 31 2024
- Status last verified
- Jun 2024
- First submitted
- 24 May 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Low Pressure Pneumoperitoneum with High Pressure Pneumoperitoneum in Post-operative Pain, Shoulder Tip Pain and Common Bile Duct Injuries in Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06447545
- Acronym / sponsor ID
- AAMC/IRB/EA 31 2024
- Conditions
- Cholecystectomy, Pneumoperitoneum, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Gulab Devi HospitalUniversity, hospital or other
- Study start
- 19 May 2024 (actual)
- Primary completion
- 19 May 2024 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 7 Jun 2024 (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.
This study aims to address the existing gap in knowledge by conducting a comprehensive comparison of the incidence of pain and common bile duct injuries in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum versus high pressure pneumoperitoneum.
Detailed description
Laparoscopic cholecystectomy is minimally invasive surgery to remove the gallbladder. It helps people when gallstones cause inflammation, pain or infection. Since the early 1990s, the laparoscopic cholecystectomy technique has largely supplanted the open approach for routine gallbladder removal. This method is recommended for various conditions such as cholecystitis (both acute and chronic), symptomatic cholelithiasis, biliary dyskinesia, acalculous cholecystitis, gallstone pancreatitis, and gallbladder masses/polyps-similar to the indications for an open cholecystectomy. Gallbladder cancers, however, are typically better addressed through open cholecystectomy. In the United States, around 20 million people have gallstones, leading to approximately 300,000 cholecystectomies annually. Ten to fifteen percent of the population has asymptomatic gallstones, and among them, 20% experience symptoms such as biliary colic. Complications, including acute cholecystitis, gallstone pancreatitis, choledocholithiasis, and gallstone ileus, manifest in approximately 1% to 4% of symptomatic cases. Gallstone prevalence increases with age, with women between 50 to 65 years having a 20% incidence, compared to 5% in men. Cholesterol constitutes 75% of gallstones, while the remaining 25% are pigmented; however, clinical signs and symptoms remain consistent regardless of the gallstone composition.1 Low-pressure and high-pressure pneumoperitoneum, both integral to laparoscopic cholecystectomy, have been subjects of extensive research, primarily focusing on their impact on post-operative pain management.
Traditionally, in laparoscopic cholecystectomy, one of the initial procedures involves creating pneumoperitoneum. This is done by introducing carbon dioxide (CO2) either through a veress needle or a port in the abdominal wall. The CO2 is then gently infused into the peritoneal cavity, reaching a pressure of 10-20 mmHg, at a rate of 4-6 litres per minute. To maintain the pneumoperitoneum, a steady gas flow of 200-400 ml/min is sustained. In conventional laparoscopic cholecystectomy, a higher intra-abdominal pressure of 12-15mmHg is used, while low-pressure pneumoperitoneum laparoscopic cholecystectomy employs pressures below 8mmHg.2 High-pressure pneumoperitoneum, involving insufflation pressures typically ranging from 12 to 15 mmHg or higher, facilitates enhanced intraoperative visualization, ease of surgical manipulation, and shorter operative times. However, despite these advantages, it commonly correlates with increased post-operative pain and discomfort, particularly in the form of referred shoulder pain. The mechanism behind this pain is attributed to diaphragmatic irritation and irritation of the phrenic nerve due to the increased pressure within the peritoneal cavity.3 In contrast, low-pressure pneumoperitoneum, characterized by lower insufflation pressures, often ranging from 8 to 12 mmHg, aims to mitigate the post-operative discomfort experienced by patients. Studies exploring the use of lower pressures have indicated promising outcomes in reducing post-operative pain levels, shoulder discomfort, and overall patient discomfort following laparoscopic cholecystectomy.4 Although low-pressure pneumoperitoneum may potentially prolong the operative duration due to decreased visibility and the need for more delicate surgical manoeuvres, it presents a viable option for patients prone to experiencing heightened post-operative pain. The advantages of decreased pain, reduced shoulder discomfort, and potentially faster recovery post-surgery make low-pressure pneumoperitoneum an appealing consideration, especially for patients with a lower threshold for pain or those with a history of difficulties in managing post-operative discomfort. According to recent study pain was experienced in 22.5 % in Low pressure vs 57% in high pressure pneumoperitoneum technique 5,6
Bile duct injury (BDI) following cholecystectomy, particularly laparoscopic cholecystectomy (LC), is indeed a serious complication associated with significant morbidity and mortality. The incidence of BDI has increased with the adoption of laparoscopic techniques. The complications often result from anatomical misperceptions or inadvertent dissection, leading to injury to the common bile duct (CBD). Several factors contribute to the increased incidence of BDI in LC compared to open cholecystectomy. These include disorientation of anatomical variables, inadvertent dissection at Calot's triangle, or visual misperception by the operating surgeon. Proximal injuries, occurring within 2cm from the bifurcation, are becoming more prevalent. Recognition of CBD injury is crucial for prompt and effective management, as delayed diagnosis can lead to severe complications such as systemic inflammatory response syndrome and multi-organ failure syndrome. The time of presentation of these injuries can vary, making early detection challenging. Preventing common bile duct injury involves several key principles:
- Optimal Exposure of Calot's Triangle: Proper exposure of Calot's triangle allows the surgeon to visualize the anatomical structures clearly, reducing the risk of inadvertent injury.
- Judicious Use of Diathermy Near CBD Territory: Careful use of diathermy (electrosurgery) near the CBD is essential to avoid thermal injury. Excessive use of diathermy can lead to tissue damage and increase the risk of bile duct injury.
- Use of a 30-Degree Telescope: A 30-degree laparoscope provides a better angle of vision, enhancing the surgeon's ability to visualize anatomical structures accurately during laparoscopic procedures.
- Safe Clip Application without Tenting of CBD: Applying clips to secure structures without tenting the CBD helps avoid compression and potential injury. Proper clip placement is crucial for securing structures while minimizing the risk of damage to nearby tissues.
- Adherence to the Rule of Thumb: Surgeons should be mindful of the "rule of thumb" to prevent common bile duct injury. This involves meticulous and precise surgical technique, including gentle tissue handling and avoiding excessive traction on the structures.
In conclusion, preventing common bile duct injury during cholecystectomy requires a combination of technical skill, anatomical knowledge, and adherence to established principles. Surgeons must be vigilant and adopt a cautious approach to minimize the risk of this serious complication. Early recognition and active management of CBD injuries are essential for improving patient outcomes and reducing morbidity and mortality associated with this iatrogenic catastrophe7.
The choice between these techniques involves a careful consideration of multiple factors, including the specific characteristics of the patient, the surgeon's expertise, and the complexities of the surgical procedure. As medical practitioners continue to explore ways to enhance patient outcomes and minimize post-operative discomfort, the debate between low-pressure and high-pressure pneumoperitoneum in laparoscopic cholecystectomy remains an active area of research and clinical consideration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Pressure Pneumoperitoneum | Other | Device: Changing pressure of Pneumoperitoneum to 6-10 mmHglow-pressure pneumoperitoneum in which the pressure is (6-10 mmHg) |
| High Pressure Pneumoperitoneum | Other | Device: Changing pressure of Pneumoperitoneum to 12-15 mmHgHigh-pressure pneumoperitoneum, involving insufflation pressures typically ranging from 12 to 15 mmHg or higher |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients from both genders
- Patients undergoing laparoscopic cholecystectomy for cholelithiasis.
Key exclusion criteria (2 listed)
- Patients with cardiac abnormalities.
- Patients with previous abdominal surgeries.
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 |
|---|---|---|
| Changing pressure of Pneumoperitoneum to 6-10 mmHgAlso: Low Pressure PneumoperitoneumResult of changing pneumoperitoneum pressure on CBD injury and pain | Device | Low Pressure Pneumoperitoneum |
| Changing pressure of Pneumoperitoneum to 12-15 mmHgAlso: High Pressure PneumoperitoneumResult of changing pneumoperitoneum pressure on CBD injury and pain | Device | High Pressure Pneumoperitoneum |
Primary outcome
The incidence of pain and common bile duct injury in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum is less versus High pressure pneumoperitoneum.
Time frame: 6 months
Pain will accessed using VAS. Pain (VAS): The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). It was assessed at 4, 8, 12 hours post-operatively by using Visual Analogue Pain Scale. No pain |0____1____2____3____4____5____6____7____8____9____10| sever pain Mild pain-Moderate Pain-Sever pain Visual Analogue Pain Scale And CBD injury will be accessed using bismuth classification. CBD INJURY: Injury to CBD Is Classified According to Bismuth Classification: Type I is a low injury with a stump length more than 2 cm. Type II is a middle level injury with a stump length less than 2 cm. Type III is a high-level injury without common hepatic duct available but preserved confluence. Type IV involves loss of hepatic confluence with no communication between right and left ducts.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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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.
M. Zia-ul-Miraj Ahmad, MBBS,FRCS study director
Gulab Devi 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 Changing pressure of Pneumoperitoneum to 6-10 mmHg and Changing pressure of Pneumoperitoneum to 12-15 mmHg in people with Cholecystectomy and Pneumoperitoneum, run by Gulab Devi Hospital at 1 site in Pakistan.
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 2 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 4 Dec 2024. 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 Pakistan. 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 Zain Himayoun, MBBS (03043862033, zain.1080@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of pain and common bile duct injury in patients undergoing laparoscopic cholecystectomy using Low pressure pneumoperitoneum is less versus High pressure pneumoperitoneum. (time frame: 6 months). 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 4 Dec 2024.