A phase IV, blinded, randomized controlled trial to compare the effectiveness of low pressure pneumoperitoneum during laparoscopic donor nephrectomy to optimize the quality-of-recovery during the early post-operative phase

A phase IV, blinded, randomized controlled trial to compare the effectiveness of low pressure pneumoperitoneum during laparoscopic donor nephrectomy to optimize the quality-of-recovery during the early post-operative phase - LEOPARD-2 study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40838

Enrollment

Registered

2014-07-10

Start date

2014-08-26

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

donor nephrectomy kidney donation

Interventions

The patient will be randomized in one the following study groups: • Standard pressure pneumoperitoneum (12 mmHg) • Low pressure pneumoperitoneum (6 mmHg)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Obtained informed consent Age over 18 years

Exclusion criteria

Exclusion criteria: • insufficient control of the Dutch language to read the patient information and to fill out the questionnaires • chronic use of analgetics or psychotropic drugs • use of NSAIDs shorter than 5 days before surgery • known of suspect allergy to rocuronium or sugammadex • significant liver* or renal** dysfunction • neuromuscular disease • pregnant of breastfeeding;*Liver dysfunction is defined as alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) > twice the upper limit (extremely rare in live kidney donors) ** renal dysfunction is defined as serum creatinine twice the normal level and/or glomerular filtration rate

Design outcomes

Primary

Measure	Time frame
Quality of recovery-40 score on day 1 (overall score)	—

Secondary

Measure	Time frame
Questionnaires • Quality of recovery-40 questionnaire • Return to Work questionnaire Medication use • Cumulative morphine use • Cumulative use of other analgetics • Cumulative use of anti-emetics Clinical parameters • Components of pain assessment • Evaluation of post-operative complications, graded according to Clavien Dindo • Post-operative incidence of nausea and/or vomiting • Time until reaching discharge criteria* • Serum creatinine • Incidence of chronic pain Intra-operative parameters • Operation time (min), length of pneuoperitoneum (min), first warm ischemia time (sec) • Estimated blood loss (ml) • Conversion to open donor nephrectomy (incidence) • Conversion to hand-assisted donor nephrectomy (incidence) • Intra-operative complications (e.g. bleeding, injury to spleen or liver) • Urine output during pneumoperitoneum phase • Cumulative use of rocuronium (mg) • Cumulative use of sugammadex (mg) • Surgical rating score * Discharge criteria are: adequate paincontrole with oral analgetics, absence of nausea/vomiting, passage of flatus or defecation, intake of solid food, patient is mobilized and independent and patient accepts discharge. Discharge criteria will be evaluated daily. If the donor for social reasons wants to stay longer (e.g. long distance and partner or child is still hospitalized) than the virtual discharge date is listed. A physician who is independent (ward physician) is responsible for the actual discharge date.	—

Measure

Time frame

Questionnaires • Quality of recovery-40 questionnaire • Return to Work questionnaire Medication use • Cumulative morphine use • Cumulative use of other analgetics • Cumulative use of anti-emetics Clinical parameters • Components of pain assessment • Evaluation of post-operative complications, graded according to Clavien Dindo • Post-operative incidence of nausea and/or vomiting • Time until reaching discharge criteria* • Serum creatinine • Incidence of chronic pain Intra-operative parameters • Operation time (min), length of pneuoperitoneum (min), first warm ischemia time (sec) • Estimated blood loss (ml) • Conversion to open donor nephrectomy (incidence) • Conversion to hand-assisted donor nephrectomy (incidence) • Intra-operative complications (e.g. bleeding, injury to spleen or liver) • Urine output during pneumoperitoneum phase • Cumulative use of rocuronium (mg) • Cumulative use of sugammadex (mg) • Surgical rating score * Discharge criteria are: adequate paincontrole with oral analgetics, absence of nausea/vomiting, passage of flatus or defecation, intake of solid food, patient is mobilized and independent and patient accepts discharge. Discharge criteria will be evaluated daily. If the donor for social reasons wants to stay longer (e.g. long distance and partner or child is still hospitalized) than the *virtual* discharge date is listed. A physician who is independent (ward physician) is responsible for the actual discharge date.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)