Acute Kidney InjuryNCT04755452
The Effect of Pneumoperitoneum (Raised Pressure in the Peritoneal Cavity) During Robotic Kidney/Prostate Cancer Surgery.
A study testing Low intra-abdominal pressure and High (standard) intra-abdominal pressure in people with Acute Kidney Injury and Pneumoperitoneum, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Within all the surgical specialties, major surgeries are performed whenever possible, as minimally invasive procedures to reduce blood loss, reduce pain and discomfort after surgery, avoid major scars, provide a faster recovery and thus shorter hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury, Pneumoperitoneum, Kidney
- What is being tested?
- Low intra-abdominal pressure and High (standard) intra-abdominal pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Dec 2020to 28 Feb 2022
- 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
- Patients diagnosed with kidney/prostate cancer at the department of Urology, Aalborg University Hospital, who are offered radical nephrectomy/prostatectomy.
- Speaks and understands Danish
Who cannot join
- Patient diagnosed with kidney cancer but can be treated with partial nephrectomy.
- Patients with severe to end stage chronic kidney disease (CKD stage 4-5)
- Inability to understand or comply with instructions.
- Withdrawal Criteria:
- Inability to complete the surgery without raising the pneumoperitoneum for low pneumoperitoneum arm.
- Complications that require re-operation which can change the quality of recovery of primary operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pneumoperitoneum During Robot Assisted Laparoscopic Renal/ Prostatic Cancer Surgery - a Randomized Clinical Study Investigating Patient and Surgeon Outcome.
Within all the surgical specialties, major surgeries are performed whenever possible, as minimally invasive procedures to reduce blood loss, reduce pain and discomfort after surgery, avoid major scars, provide a faster recovery and thus shorter hospital stay. Such minimally invasive procedures in urinary tract surgeries are often performed as laparoscopic or robotic surgeries where CO2 (carbon dioxide) is insufflated into the abdominal cavity to create a working space for the surgeon's instruments. That high pressure created in the abdominal cavity (pneumoperitoneum) to create a workspace for the surgeon start a series of physiological changes in the heart, lung and kidney.
Today, most laparoscopic, and robotic operations are performed with pneumoperitoneum of approximately 12-15 mm Hg, despite the fact that international guidelines recommend the use of the lowest intra-abdominal pressure (IAP) possible allowing adequate exposure of the operative field rather than using a routine pressure level.
Read more
Investigator will conduct a randomized double-blind study involving 120 patients (2 groups of 60). The first group will be operated with standard pressure in the abdominal cavity 12-15 mm Hg (high IAP), patients in the second group will be operated on with a reduced pressure of ≈ 7 mmHg (low IAP).
Investigator would like to assess the practical feasibility of operating under low IAP. Quality of recovery of patients in relation to both physical and mental status, and post-operative use of pain killer will be also investigated using a validated questionnaire . Finally, Invistigator will examine the impact of IAP on post-operative renal function, and risk of kidney injury.
Hypothesis is carrying out laparoscopic/robotic surgeries under low IAP can optimize the post-operative quality of recovery, decrease pain and use of pain killer, improve post-operative renal function, and decrease risk for kidney injury. On the other hand low IAP can risk overview for surgeon, make workspace smaller and raise risk of bleeding.
Read the detailed description
A total of 120 patients between the ages of 18 and 80 years who were scheduled for elective robotic radical nephrectomy/ prostatectomy will included in the study. This is randomized controlled double-blind clinical trial.
A standard anesthesia protocol will be used in both groups. Bladder catheter inserted by the OP-nurse. After ports installment under IAP of 7 mm Hg, the surgeon leaves the operation field and sits at a surgical console. The ground nurse opens the sealed letter which indicated the pressure for operation (electronic randomization was previously performed by investigator using https://www.graphpad.com/quickcalcs/index.cfm) The required IAP sets by the ground nurse before the surgery started. Assistants are not blinded in the study, but the surgeon is. Intra-abdominal pressure will be maintained at 7 mmHg in Group Low IAP and at 12 mmHg in Group High IAP throughout the surgery. If under operation the surgeon required to raise the IAP because of bad views, or bleeding, he/she can always ask the ground nurse to raise the pressure by 2- or 3-mm Hg at a time until surgeon obtain the preferred view. This involved both groups. Patient will not be excluded from study if pressure increased, but the duration of raised IAP will be registered.
During the operation, the surgical working space will be evaluated by surgeon using an adopted version of SRS (Surgical rating scale). 1st time during mobilization of bowel, 2nd time during renal vascular dissection, and last time when surgeon remove the kidney and set it in the Endobag.
All patients asked to register their 24-hour urine production before the operation day. Intra-operative urine output will be also registered. 10 ml urine will be collected 3 times in order to investigate the risk of Acute Kidney Injury (AKI) by kidney injury biomarker (u-NGAL, og KIM-1). Pre-operatively during urinary catheter placement, 2-hour post-operatively, and 24 hours after operation. Urine samples collected and stored in -80 C for later analyses.
Investigator will test the quality of recovery using a validated Quality of recovery-15 (QoR-15) questionnaire before the surgery and at day 1,3,14,30 post-op.
- Conditions
- Acute Kidney Injury, Pneumoperitoneum, Kidney
- Being tested
- Low intra-abdominal pressure, High (standard) intra-abdominal pressure
- Keywords
- Quality of recovery, Surgical rating scale, intra-abdominal pressure, kidney injury biomarkers
- Medical subject headings
- Acute Kidney Injury, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intra-abdominal pressureProcedure or surgery
7 mm Hg pneumoperitoneum during robot-assisted laparoscopic surgery
High (standard) intra-abdominal pressureProcedure or surgery
12 mm Hg pneumoperitoneum during robot-assisted laparoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Low Intra-abdominal pressure | Experimental | Intra-abdominal pressure will be set at 7 mm Hg during the procedure. Receives: Procedure: Low intra-abdominal pressure |
| High (standard) intra-abdominal pressure | Active comparator | Intra-abdominal pressure will be set at 12 mm Hg during the procedure. Receives: Procedure: High (standard) intra-abdominal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
Changes in Quality of recovery assessed by QoR-15 Questionaire from pre-operative to day 30 post-operative level. Participiants fill in quistionaire pre-operatively, day 1,3,14,30
Measured: fulled by the patient pre-operatively and then on post-operative day 1,3,14 and 30
Risk Of Acute kidney injury (AKI)
post-operative renal function and risk for AKI evaluated by u-NGAL
Measured: 24 hours after surgery
Surgical rating scale
assessed 3 times during surgery. 1st during mobilization of bowel, then during renal vessels dissection, and last time during removing and insertion of kidney in the endobag.
Measured: intra-operative
Secondary outcomes (12)
post-operative use of painkillers
All post-operative painkiller registered and converted to morphine using Morphine Milligram Equivalent (MME)
Measured: 24 hours after surgery
Intra-operative urine output
Measured: intra-operative
Duration of operation in minutes
Measured: intra-operative
Intra-operative bleeding in ml
Measured: intra-operative
u- KIM-1 level
Kidney injury molecule in urine
Measured: Before surgery
u-NGAL
Neutrophil gelatinase-associated lipocalin in urine
Measured: 24 hours after surgery
u- KIM-1 level
Kidney injury molecule in urine
Measured: 24 hours after surgery
S.creatinine, and eGFR
Kidney injury marker
Measured: 24 hours after surgery
S.creatinine and eGFR
Kidney injury marker
Measured: 10 days after surgery
S.creatinine and eGFR
Kidney injury marker
Measured: 21 days after surgery
Other Kidney injury markers, include; TFF,VEGF, Osteoactivin, Clusterin, and Calbindin
Kindey injury markers
Measured: Before surgery
Other Kidney injury markers, include; TFF,VEGF, Osteoactivin, Clusterin, and Calbindin
Kidney injury markers
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start23 Dec 2020
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Aalborg University 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, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayder Alhusseinawi, Aalborg University Hospital
- Investigators
- Hayder Al-husseinawi, M.D., Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755452
- Sponsor's protocol ID
- N-2020 00 78
- Status last verified
- Jun 2023
- First submitted
- 6 Feb 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alhusseinawi H, Sander L, Handberg A, Rasmussen RW, Kingo PS, Jensen JB, Rasmussen S. Impact of low pneumoperitoneum on renal function and acute kidney injury biomarkers during robot-assisted radical prostatectomy (RARP): a randomised clinical trial. J Robot Surg. 2024 Jan 17;18(1):31. doi: 10.1007/s11701-023-01744-2.
PubMed 38231282Alhusseinawi H, Sander L, Rosenvinge PM, Jensen SL, Bruun NH, Kingo PS, Jensen JB, Rasmussen S. Low- versus standard- pneumoperitoneum in patients undergoing robot-assisted radical prostatectomy: a randomised, triple-blinded study. BJU Int. 2023 Nov;132(5):560-567. doi: 10.1111/bju.16099. Epub 2023 Jun 26.
PubMed 37358048
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pneumoperitoneum During Robot Assisted Laparoscopic Renal/ Prostatic Cancer Surgery - a Randomized Clinical Study Investigating Patient and Surgeon Outcome.
- ClinicalTrials.gov ID
- NCT04755452
- Acronym / sponsor ID
- N-2020 00 78
- Conditions
- Acute Kidney Injury, Pneumoperitoneum, Kidney
- Keywords
- Quality of recovery, Surgical rating scale, intra-abdominal pressure, kidney injury biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 16 Feb 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.
Within all the surgical specialties, major surgeries are performed whenever possible, as minimally invasive procedures to reduce blood loss, reduce pain and discomfort after surgery, avoid major scars, provide a faster recovery and thus shorter hospital stay. Such minimally invasive procedures in urinary tract surgeries are often performed as laparoscopic or robotic surgeries where CO2 (carbon dioxide) is insufflated into the abdominal cavity to create a working space for the surgeon's instruments. That high pressure created in the abdominal cavity (pneumoperitoneum) to create a workspace for the surgeon start a series of physiological changes in the heart, lung and kidney.
Today, most laparoscopic, and robotic operations are performed with pneumoperitoneum of approximately 12-15 mm Hg, despite the fact that international guidelines recommend the use of the lowest intra-abdominal pressure (IAP) possible allowing adequate exposure of the operative field rather than using a routine pressure level.
Investigator will conduct a randomized double-blind study involving 120 patients (2 groups of 60). The first group will be operated with standard pressure in the abdominal cavity 12-15 mm Hg (high IAP), patients in the second group will be operated on with a reduced pressure of ≈ 7 mmHg (low IAP).
Investigator would like to assess the practical feasibility of operating under low IAP. Quality of recovery of patients in relation to both physical and mental status, and post-operative use of pain killer will be also investigated using a validated questionnaire . Finally, Invistigator will examine the impact of IAP on post-operative renal function, and risk of kidney injury.
Hypothesis is carrying out laparoscopic/robotic surgeries under low IAP can optimize the post-operative quality of recovery, decrease pain and use of pain killer, improve post-operative renal function, and decrease risk for kidney injury. On the other hand low IAP can risk overview for surgeon, make workspace smaller and raise risk of bleeding.
Detailed description
A total of 120 patients between the ages of 18 and 80 years who were scheduled for elective robotic radical nephrectomy/ prostatectomy will included in the study. This is randomized controlled double-blind clinical trial.
A standard anesthesia protocol will be used in both groups. Bladder catheter inserted by the OP-nurse. After ports installment under IAP of 7 mm Hg, the surgeon leaves the operation field and sits at a surgical console. The ground nurse opens the sealed letter which indicated the pressure for operation (electronic randomization was previously performed by investigator using https://www.graphpad.com/quickcalcs/index.cfm) The required IAP sets by the ground nurse before the surgery started. Assistants are not blinded in the study, but the surgeon is. Intra-abdominal pressure will be maintained at 7 mmHg in Group Low IAP and at 12 mmHg in Group High IAP throughout the surgery. If under operation the surgeon required to raise the IAP because of bad views, or bleeding, he/she can always ask the ground nurse to raise the pressure by 2- or 3-mm Hg at a time until surgeon obtain the preferred view. This involved both groups. Patient will not be excluded from study if pressure increased, but the duration of raised IAP will be registered.
During the operation, the surgical working space will be evaluated by surgeon using an adopted version of SRS (Surgical rating scale). 1st time during mobilization of bowel, 2nd time during renal vascular dissection, and last time when surgeon remove the kidney and set it in the Endobag.
All patients asked to register their 24-hour urine production before the operation day. Intra-operative urine output will be also registered. 10 ml urine will be collected 3 times in order to investigate the risk of Acute Kidney Injury (AKI) by kidney injury biomarker (u-NGAL, og KIM-1). Pre-operatively during urinary catheter placement, 2-hour post-operatively, and 24 hours after operation. Urine samples collected and stored in -80 C for later analyses.
Investigator will test the quality of recovery using a validated Quality of recovery-15 (QoR-15) questionnaire before the surgery and at day 1,3,14,30 post-op.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Intra-abdominal pressure | Experimental | Procedure: Low intra-abdominal pressureIntra-abdominal pressure will be set at 7 mm Hg during the procedure. |
| High (standard) intra-abdominal pressure | Active comparator | Procedure: High (standard) intra-abdominal pressureIntra-abdominal pressure will be set at 12 mm Hg during the procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with kidney/prostate cancer at the department of Urology, Aalborg University Hospital, who are offered radical nephrectomy/prostatectomy.
- Speaks and understands Danish
Key exclusion criteria (6 listed)
- Patient diagnosed with kidney cancer but can be treated with partial nephrectomy.
- Patients with severe to end stage chronic kidney disease (CKD stage 4-5)
- Inability to understand or comply with instructions.
- Inability to complete the surgery without raising the pneumoperitoneum for low pneumoperitoneum arm.
- Complications that require re-operation which can change the quality of recovery of primary operation.
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 intra-abdominal pressure7 mm Hg pneumoperitoneum during robot-assisted laparoscopic surgery | Procedure or surgery | Low Intra-abdominal pressure |
| High (standard) intra-abdominal pressure12 mm Hg pneumoperitoneum during robot-assisted laparoscopic surgery | Procedure or surgery | High (standard) intra-abdominal pressure |
Primary outcome
Quality of recovery
Time frame: fulled by the patient pre-operatively and then on post-operative day 1,3,14 and 30
Changes in Quality of recovery assessed by QoR-15 Questionaire from pre-operative to day 30 post-operative level. Participiants fill in quistionaire pre-operatively, day 1,3,14,30
Risk Of Acute kidney injury (AKI)
Time frame: 24 hours after surgery
post-operative renal function and risk for AKI evaluated by u-NGAL
Surgical rating scale
Time frame: intra-operative
assessed 3 times during surgery. 1st during mobilization of bowel, then during renal vessels dissection, and last time during removing and insertion of kidney in the endobag.
12 secondary outcomes
post-operative use of painkillers
Time frame: 24 hours after surgery
Intra-operative urine output
Time frame: intra-operative
Duration of operation in minutes
Time frame: intra-operative
Intra-operative bleeding in ml
Time frame: intra-operative
u- KIM-1 level
Time frame: Before surgery
u-NGAL
Time frame: 24 hours after surgery
u- KIM-1 level
Time frame: 24 hours after surgery
S.creatinine, and eGFR
Time frame: 24 hours after surgery
S.creatinine and eGFR
Time frame: 10 days after surgery
S.creatinine and eGFR
Time frame: 21 days after surgery
Other Kidney injury markers, include; TFF,VEGF, Osteoactivin, Clusterin, and Calbindin
Time frame: Before surgery
Other Kidney injury markers, include; TFF,VEGF, Osteoactivin, Clusterin, and Calbindin
Time frame: 24 hours after surgery
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 22 Jun 2023.
- Derived from this study: PubMed 38231282Alhusseinawi H, Sander L, Handberg A, Rasmussen RW, Kingo PS, Jensen JB, Rasmussen S. Impact of low pneumoperitoneum on renal function and acute kidney injury biomarkers during robot-assisted radical prostatectomy (RARP): a randomised clinical trial. J Robot Surg. 2024 Jan 17;18(1):31. doi: 10.1007/s11701-023-01744-2.
- Derived from this study: PubMed 37358048Alhusseinawi H, Sander L, Rosenvinge PM, Jensen SL, Bruun NH, Kingo PS, Jensen JB, Rasmussen S. Low- versus standard- pneumoperitoneum in patients undergoing robot-assisted radical prostatectomy: a randomised, triple-blinded study. BJU Int. 2023 Nov;132(5):560-567. doi: 10.1111/bju.16099. Epub 2023 Jun 26.
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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.
Hayder Al-husseinawi, M.D. principal investigator
Aalborg University 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 intra-abdominal pressure and High (standard) intra-abdominal pressure in people with Acute Kidney Injury and Pneumoperitoneum, run by Aalborg University Hospital at 1 site in Denmark.
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 6 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 22 Jun 2023. 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 Denmark. 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?
Quality of recovery (time frame: fulled by the patient pre-operatively and then on post-operative day 1,3,14 and 30). The study lists 3 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 NCT04755452, which also lists 2 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 22 Jun 2023.