Evidence map›Paper›PMID 26265279›Full record

Trial reportTrials2015

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.

Denise M D Özdemir-van Brunschot, Gert J Scheffer, Albert Dahan, Janneke E E A Mulder, Simone A A Willems, Luuk B Hilbrands, Frank C H d'Ancona, Rogier A R T Donders, Kees J H M van Laarhoven, Michiel C Warlé

Registry-linked trialAbstract readClinical Trial, Phase IVRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02146417 (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), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02146417 nacompletednot on this map

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

TypeinterventionalSponsorRadboud University Medical CenterRan2014 to 2015Enrolled64ConditionsRenal DiseaseArmsLow pressure pneumoperitoneum, Normal pressure pneumoperitoneum (12 mmHg), Deep neuromuscular block
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Denise M D Özdemir-van BrunschotDepartment of Surgery, Division of Vascular and Transplant Surgery, Radboud University Medical Center, Geert Grooteplein-Zuid 10, Nijmegen, 6525 GA, The Netherlands. Denise.Ozdemir-vanBrunschot@radboudumc.nl.
Gert J SchefferDepartment of Anesthesiology, Radboud University Medical Center, Nijmegen, The Netherlands. GertJan.Scheffer@radboudumc.nl.
Albert DahanDepartment of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands. A.Dahan@lumc.nl.
Janneke E E A MulderDepartment of Anesthesiology, Radboud University Medical Center, Nijmegen, The Netherlands. Janneke.Mulder@radboudumc.nl.
Simone A A WillemsDepartment of Anesthesiology, Radboud University Medical Center, Nijmegen, The Netherlands. Willems@radboudumc.nl.
Luuk B HilbrandsDepartment of Nephrology, Radboud University Medical Center, Nijmegen, The Netherlands. Luuk.Hilbrands@radboudumc.nl.
Frank C H d'AnconaDepartment of Urology, Radboud University Medical Center, Nijmegen, The Netherlands. Frank.dAncona@radboudumc.nl.
Rogier A R T DondersDepartment of Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands. Rogier.Donders@radboudumc.nl.
Kees J H M van LaarhovenDepartment of Surgery, Division of Vascular and Transplant Surgery, Radboud University Medical Center, Geert Grooteplein-Zuid 10, Nijmegen, 6525 GA, The Netherlands. Kees.vanLaarhoven@radboudumc.nl.
Michiel C WarléDepartment of Surgery, Division of Vascular and Transplant Surgery, Radboud University Medical Center, Geert Grooteplein-Zuid 10, Nijmegen, 6525 GA, The Netherlands. Michiel.Warle@radboudumc.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSince technique modifications of laparoscopic donor nephrectomy, e.g. retroperitoneoscopic donor nephrectomy or hand-assistance, have not shown significant benefit regarding safety or improvement of recovery, further research should focus on improving postoperative recovery. The use of low pressure pneumoperitoneum has shown to significantly reduce postoperative pain after laparoscopy. To facilitate the use of low pressure pneumoperitoneum, deep neuromuscular block will be used. METHODS/

designThis trial is a phase IV, single center, double-blind, randomized controlled clinical trial in which 64 patients will be randomized to: low pressure pneumoperitoneum (6 mmHg) and deep neuromuscular block or normal pressure pneumoperitoneum (12 mmHg) and deep neuromuscular block. Deep neuromuscular block is defined as post tetanic count < 5. Primary outcome measurement will be Quality of Recovery-40 questionnaire (overall score) on day 1. DISCUSSION: This study is the first randomized study to assess the combination of low pressure pneumoperitoneum in combination with deep neuromuscular block from a patients' perspective. The study findings may also be applicable for other laparoscopic procedures.

trial registrationThe trial was registered at trials.gov (NCT02146417) in July 2014.

Indexed as

LaparoscopyLiving DonorsNeuromuscular BlockadeClinical ProtocolsDouble-Blind MethodHumansKidney TransplantationNephrectomyNetherlandsPain MeasurementPneumoperitoneum, ArtificialPostoperative PainRecovery of FunctionResearch DesignSurveys and QuestionnairesTime Factors

Identifiers

PMID26265279
PMCPMC4533955

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.