Low impact laparoscopy (low pressure pneumoperitoneum and deep neuromuscular blockade) versus standard laparoscopy during robot assisted radical prostatectomy to improve the quality of recovery and immune homeostasis; a randomized controlled study.

Low impact laparoscopy (low pressure pneumoperitoneum and deep neuromuscular blockade) versus standard laparoscopy during robot assisted radical prostatectomy to improve the quality of recovery and immune homeostasis; a randomized controlled study. - RECOVER 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49113

Enrollment

Registered

2020-05-26

Start date

2020-12-13

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperatief herstel en effect op immuunsysteem na robotgeassisteerd laparoscopische ingrepen. Postoperative recovery and immune homeostasis

Interventions

The participants will be randomly assigned in a 1:1 fashion to: - Experimental group: low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2)) - Control group: standard laparoscopy (stan

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age * 18 years - Undergoing elective robot assisted radical prostatectomy (RARP) - Obtained informed consent

Exclusion criteria

Exclusion criteria: - Laparoscopic radical prostatectomy without robot assistance - Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires - Neo-adjuvant chemotherapy - Chronic use of analgesics or psychotropic drugs - Use of NSAID*s shorter than 5 days before surgery - Severe liver- or renal disease - Neuromuscular disease - Hyperthyroidism or thyroid adenomas - Deficiency of vitamin K dependent clotting factors or coagulopathy - Planned diagnostics or treatment with radioactive iodine 35kg/m2 - Known of suspected hypersensitivity to ICG, sodium iodide, iodine, rocuronium or sugammadex - Use of medication interfering with ICG absorption as listed in the summary of product characteristics (SPC); anticonvulsants, bisulphite compounds, haloperidol, heroin, meperidine, metamizol, methadone, morphium, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, cyclopropane, probencid.

Design outcomes

Primary

Measure	Time frame
- Quality of recovery score (QoR-40) at postoperative day 1. - IL-6 and IL-10 response upon whole blood LPS stimulation at postoperative day 7. - Perfusion index of the parietal peritoneum as calculated from the slope of ICG fluorescence intensity, and time to maximal intensity in seconds. (extracted from video registration).	—

Secondary

Measure	Time frame
QoR-40 score (day 1 and day 10-12), SF-36 score (1 day before, 10-12 days and 3 months after surgery), McGill pain questionnaire (3 months after surgery), pain scores, analgesia use, PONV, time to reach discharge criteria, length of hospital stay, surgical conditions and postoperative complications scored by Clavien Dindo classification.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)