The Effect of Pneumoperitoneum (Raised Pressure in the Peritoneal Cavity) During Robotic Kidney/Prostate Cancer Surgery.

NCT04755452 | Completed DMC

• 1 other identifier: N-2020 00 78
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Acute Kidney Injury; Pneumoperitoneum; Kidney

Keywords

Quality of recovery; Surgical rating scale; intra-abdominal pressure; kidney injury biomarkers

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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.

  intra-operative

Secondary Outcomes (12)

• post-operative use of painkillers

  24 hours after surgery

• Intra-operative urine output

  intra-operative

• Duration of operation in minutes

  intra-operative

• Intra-operative bleeding in ml

  intra-operative

• u- KIM-1 level

  Before surgery

Study Arms (2)

Low Intra-abdominal pressure

EXPERIMENTAL

Intra-abdominal pressure will be set at 7 mm Hg during the procedure.

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.

Procedure: High (standard) intra-abdominal pressure

Interventions

Low intra-abdominal pressure PROCEDURE

7 mm Hg pneumoperitoneum during robot-assisted laparoscopic surgery

Low Intra-abdominal pressure

High (standard) intra-abdominal pressure PROCEDURE

12 mm Hg pneumoperitoneum during robot-assisted laparoscopic surgery

High (standard) intra-abdominal pressure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with kidney/prostate cancer at the department of Urology, Aalborg University Hospital, who are offered radical nephrectomy/prostatectomy.
• Speaks and understands Danish

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg university hospital

Aalborg, North Jutland, 9000, Denmark

Location

Related Publications (2)

• 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.

  PMID: 38231282 DERIVED

• Alhusseinawi 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 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Pneumoperitoneum

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Hayder Al-husseinawi, M.D.

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Medical Doctor, PhD student

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 16, 2021
• Study Start: December 23, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

DK (1)