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

NCT04755452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-06-22

No results posted yet for this study

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

Interventions

PROCEDURE

Low intra-abdominal pressure

7 mm Hg pneumoperitoneum during robot-assisted laparoscopic surgery

PROCEDURE

High (standard) intra-abdominal pressure

12 mm Hg pneumoperitoneum during robot-assisted laparoscopic surgery

Sponsors & Collaborators

  • Aalborg University Hospital

    lead OTHER

Principal Investigators

  • Hayder Al-husseinawi, M.D. · Aalborg University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-23
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04755452 on ClinicalTrials.gov