Comparison of Low Versus Normal Pressure Pneumoperitoneum - With Profound Low Versus Normal Pressure Pneumoperitoneum -With Profound Muscle Relaxation- During Laparoscopic Donor Nephrectomy (LEOPARD2)
Primary Purpose
Renal Disease
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Low pressure pneumoperitoneum
Normal pressure pneumoperitoneum (12 mmHg)
Deep neuromuscular block
Sponsored by
About this trial
This is an interventional treatment trial for Renal Disease focused on measuring Low pressure pneumoperitoneum, Deep neuromuscular block
Eligibility Criteria
Inclusion Criteria:
- obtained informed consent
- age over 18 years
Exclusion Criteria:
- insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
- chronic use of analgesics or psychotropic drugs
- use of non-steroidal anti-inflammatory drugs shorter than 5 days before surgery
- known or suspect allergy to rocuronium or sugammadex
- significant liver* or renal** dysfunction
- neuromuscular disease
- pregnant of breastfeeding
indication for rapid sequence induction
- 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 < 60 ml/min (extremely rare in live kidney donors)
Sites / Locations
- Radboudumc
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Normal pressure pneumoperitoneum & deep neuromuscular block
Low pressure pneumoperitoneum & deep neuromuscular block
Arm Description
Normal pressure pneumoperitoneum
Low pressure pneumoperitoneum
Outcomes
Primary Outcome Measures
Quality-of-Recovery 40 scale
Secondary Outcome Measures
Cumulative use of opioids
Cumulative use of other analgetics
Post-operative complications
Time to reach discharge criteria
Full Information
NCT ID
NCT02146417
First Posted
May 21, 2014
Last Updated
November 9, 2015
Sponsor
Radboud University Medical Center
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT02146417
Brief Title
Comparison of Low Versus Normal Pressure Pneumoperitoneum - With Profound Low Versus Normal Pressure Pneumoperitoneum -With Profound Muscle Relaxation- During Laparoscopic Donor Nephrectomy
Acronym
LEOPARD2
Official Title
A Phase IV, Blinded, Randomized Controlled Trial to Compare the Effectiveness of Low Pressure Pneumoperitoneum - With Profound Muscle Relaxation - During Laparoscopic Donor Nephrectomy to Optimize the Quality-of-recovery During the Early Post-operative Phase
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
As both patients with end-stage kidney disease and society benefit tremendously from live kidney donation, the safety and well-being of kidney donors are highly important objectives in live kidney donation. Laparoscopic donor nephrectomy has several advantages over open nephrectomy, such as less post-operative pain, better quality of life and shorter hospital stay. Therefore, laparoscopic donor nephrectomy is nowadays the treatment of choice in most countries.
So far, modifications of the technique of laparoscopic donor nephrectomy, i.e. hand-assisted and/or retroperitoneoscopic approaches, did not show a significant benefit with regard to safety as reflected by the conversion to open and postoperative complications rate. We therefore believe that further research should focus on the optimization of early postoperative pain and its concomitant use of opioids. Since non-steroidal anti-inflammatory drugs are contra-indicated before and after nephrectomy, the management of postoperative pain largely depends on the administration of opioids. Measures to reduce postoperative pain would also reduce the occurrence of postoperative nausea and vomitus, and postoperative bowel dysfunction.
A recent pilot study performed by our group showed that the use of low pressure pneumoperitoneum was feasible and significantly reduced deep intra-abdominal and referred pain score during the first 72 hours after surgery. Previous studies performed by others show that low pressure pneumoperitoneum is associated with reduction of systemic inflammatory response, post-operative pain and analgesic consumption. Martini et al have shown that deep neuromuscular block improves surgical conditions during laparoscopic surgery with standard intra-abdominal pressure. To facilitate the use of low pressure pneumoperitoneum, deep neuromuscular block improves surgical conditions and might become a prerequisite for the use of low pressure pneumoperitoneum.
Our hypothesis is that the combination of low pressure pneumoperitoneum and deep neuromuscular block improves quality of recovery in the early post-operative phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Disease
Keywords
Low pressure pneumoperitoneum, Deep neuromuscular block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal pressure pneumoperitoneum & deep neuromuscular block
Arm Type
Active Comparator
Arm Description
Normal pressure pneumoperitoneum
Arm Title
Low pressure pneumoperitoneum & deep neuromuscular block
Arm Type
Experimental
Arm Description
Low pressure pneumoperitoneum
Intervention Type
Procedure
Intervention Name(s)
Low pressure pneumoperitoneum
Intervention Type
Procedure
Intervention Name(s)
Normal pressure pneumoperitoneum (12 mmHg)
Intervention Type
Procedure
Intervention Name(s)
Deep neuromuscular block
Primary Outcome Measure Information:
Title
Quality-of-Recovery 40 scale
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Cumulative use of opioids
Time Frame
Day -1;0;1;2;3 and Mon3
Title
Cumulative use of other analgetics
Time Frame
Day -1;0;1;2;3
Title
Post-operative complications
Time Frame
Day 0;1;2;3 and Month 3
Title
Time to reach discharge criteria
Time Frame
Day 0;1;2;3
Other Pre-specified Outcome Measures:
Title
Operation time
Time Frame
Peri-operative
Title
Length of pneumoperitoneum
Time Frame
Peri-operative
Title
Estimated blood loss
Time Frame
Peri-operative
Title
Intra-operative complications
Time Frame
Peri-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
obtained informed consent
age over 18 years
Exclusion Criteria:
insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
chronic use of analgesics or psychotropic drugs
use of non-steroidal anti-inflammatory drugs shorter than 5 days before surgery
known or suspect allergy to rocuronium or sugammadex
significant liver* or renal** dysfunction
neuromuscular disease
pregnant of breastfeeding
indication for rapid sequence induction
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 < 60 ml/min (extremely rare in live kidney donors)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiel Warlé, MD PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
34879862
Citation
Reijnders-Boerboom GTJA, van Helden EV, Minnee RC, Albers KI, Bruintjes MHD, Dahan A, Martini CH, d'Ancona FCH, Scheffer GJ, Keijzer C, Warle MC. Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials. Perioper Med (Lond). 2021 Dec 9;10(1):56. doi: 10.1186/s13741-021-00224-1.
Results Reference
derived
PubMed Identifier
32107359
Citation
Albers KI, van Helden EV, Dahan A, Martini CH, Bruintjes MHD, Scheffer GJ, Steegers MAH, Keijzer C, Warle MC. Early postoperative pain after laparoscopic donor nephrectomy predicts 30-day postoperative infectious complications: a pooled analysis of randomized controlled trials. Pain. 2020 Jul;161(7):1565-1570. doi: 10.1097/j.pain.0000000000001842.
Results Reference
derived
PubMed Identifier
28608013
Citation
Ozdemir-van Brunschot DMD, Scheffer GJ, van der Jagt M, Langenhuijsen H, Dahan A, Mulder JEEA, Willems S, Hilbrands LB, Donders R, van Laarhoven CJHM, d'Ancona FA, Warle MC. Quality of Recovery After Low-Pressure Laparoscopic Donor Nephrectomy Facilitated by Deep Neuromuscular Blockade: A Randomized Controlled Study. World J Surg. 2017 Nov;41(11):2950-2958. doi: 10.1007/s00268-017-4080-x. Erratum In: World J Surg. 2017 Aug 18;:
Results Reference
derived
PubMed Identifier
26265279
Citation
Ozdemir-van Brunschot DM, Scheffer GJ, Dahan A, Mulder JE, Willems SA, Hilbrands LB, d'Ancona FC, Donders RA, van Laarhoven KJ, Warle MC. Comparison of the effectiveness of low pressure pneumoperitoneum with profound muscle relaxation during laparoscopic donor nephrectomy to optimize the quality of recovery during the early post-operative phase: study protocol for a randomized controlled clinical trial. Trials. 2015 Aug 12;16:345. doi: 10.1186/s13063-015-0887-7.
Results Reference
derived
Learn more about this trial
Comparison of Low Versus Normal Pressure Pneumoperitoneum - With Profound Low Versus Normal Pressure Pneumoperitoneum -With Profound Muscle Relaxation- During Laparoscopic Donor Nephrectomy
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