Clinical trial · Interventional
The Effect of Pneumoperitoneum (Raised Pressure in the Peritoneal Cavity) During Robotic Kidney/Prostate Cancer Surgery.
The Effect of Pneumoperitoneum During Robot Assisted Laparoscopic Renal/ Prostatic Cancer Surgery - a Randomized Clinical Study Investigating Patient and Surgeon Outcome.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Kidney Injury | — | UNRESOLVED | — |
| Kidney | — | UNRESOLVED | — |
| Pneumoperitoneum | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High (standard) intra-abdominal pressure | Procedure | — | UNRESOLVED |
| Low intra-abdominal pressure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low Intra-abdominal pressure
- description
- Intra-abdominal pressure will be set at 7 mm Hg during the procedure.
- interventionNames
- Procedure: Low intra-abdominal pressure
- type
- ACTIVE_COMPARATOR
- label
- High (standard) intra-abdominal pressure
- description
- Intra-abdominal pressure will be set at 12 mm Hg during the procedure.
- interventionNames
- Procedure: High (standard) intra-abdominal pressure
Primary outcomes (3)
- measure
- Quality of recovery
- timeFrame
- fulled by the patient pre-operatively and then on post-operative day 1,3,14 and 30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with kidney/prostate cancer at the department of Urology, Aalborg University Hospital, who are offered radical nephrectomy/prostatectomy. * Speaks and understands Danish Exclusion Criteria: * 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.
References
Publications (2)
- DERIVEDAlhusseinawi 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. PMID 38231282
- DERIVEDAlhusseinawi 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. PMID 37358048