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    Summary
    EudraCT Number:2018-001485-42
    Sponsor's Protocol Code Number:NL65290.091.18
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-001485-42
    A.3Full title of the trial
    RECOVER study: the effect of low- versus normal pressure pneumoperitoneum during laparoscopic colorectal surgery on the early quality of recovery with perioperative care according to the enhanced recovery principles.

    Substudy: the effectiveness of low pressure pneumoperitoneum during laparoscopic colorectal surgery in preserving innate immune homeostasis by reducing peritoneal mesothelial cell injury.
    RECOVER studie: het effect van lage- versus normale druk pneumoperitoneum tijdens laparoscopische colorectale chirurgie op de vroege kwaliteit van herstel met perioperatieve zorg volgens de enhanced recovery principes.

    Substudie: de effectiviteit van lage druk pneumoperitoneum tijdens laparoscopische colorectale chirurgie in het behouden van homeostase van het innate immuunsysteem door verminderde schade aan het peritoneale mesotheel.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RECOVER study: the effect of lower pressure inside the abdomen during keyhole surgery of the intestine on early recovery after surgery.
    RECOVER studie: het effect van lagere druk in de buik tijdens een kijkoperatie aan de dikke darm op vroeg herstel na de operatie.
    A.3.2Name or abbreviated title of the trial where available
    RECOVER study
    RECOVER studie
    A.4.1Sponsor's protocol code numberNL65290.091.18
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRadboudumc
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboudumc
    B.5.2Functional name of contact pointRECOVER study information
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 10, route 618
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31617171996
    B.5.6E-mailkim.albers@radboudumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Esmeron (Rocuroniumbromide)
    D.2.1.1.2Name of the Marketing Authorisation holderNV Organon
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Bridion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Laparoscopic colorectal surgery
    Laparoscopische colorectale chirurgie
    E.1.1.1Medical condition in easily understood language
    Keyhole surgery of the large intestine
    Kijkoperatie van de dikke darm
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main study: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and the early quality of recovery after laparoscopic colorectal surgery with perioperative care according to the enhanced recovery principles.
    Het effect aantonen van lage druk pneumoperitoneum gefaciliteerd door een diep neuromusculair blok op vroege kwaliteit van herstel na laparoscopische colorectale chirurgie met perioperatieve zorg volgens de enhanced recovery principes.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    RECOVER PLUS: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and innate immune function after laparoscopic colorectal surgery.

    Version 2, 02-05-2018
    RECOVER PLUS: het effect aantonen van lage druk pneumoperitoneum gefaciliteerd door een diep neuromusculair blok op de functie van het innate immuun systeem na laparoscopische colorectale chirurgie.

    Versie 2, 02-05-2018
    E.3Principal inclusion criteria
    - Scheduled for laparoscopic colorectal surgery with a primary anastomosis
    - Age ≥ 18 years
    - Obtained informed consent
    - Gepland voor laparoscopische colorectale chirurgie met een primaire anastomose
    - Leeftijd ≥ 18 jaar
    - Verkregen informed consent
    E.4Principal exclusion criteria
    - Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
    - Primary colostomy
    - Neo-adjuvant chemotherapy (substudy)
    - Chronic use of analgesics or psychotropic drugs
    - Use of NSAIDs shorter than 5 days before surgery
    - Known or suspected allergy to rocuronium of sugammadex
    - Neuromuscular disease
    - Indication for rapid sequence induction
    - Severe liver- or renal disease (creatinine clearance <30ml/min)
    - BMI >35 kg/m²
    - Deficiency of vitamin K dependent clotting factors or coagulopathy
    - Onvoldoende beheersing van de Nederlandse taal om patiënteninformatie te lezen en vragenlijsten in te
    vullen
    - Primair aanleggen van colostoma
    - Neo-adjuvante chemotherapie (substudie)
    - Chronisch gebruik van pijnstillers of psychotropica
    - Gebruik van NSAIDs korter dan 5 dagen voor de operatie
    - Bekende of vermoedelijke allergie voor rocuronium of sugammadex
    - Neuromusculaire ziekte
    - Indicatie voor rapid sequence inductie
    - Ernstig lever- of nierfalen (creatinine klaring <30 ml/min)
    - BMI >35 kg/m²
    - Deficiëntie van vitamine K afhankelijke stollingsfactoren of coagulopathie
    E.5 End points
    E.5.1Primary end point(s)
    Quality of recovery (QoR-40) questionnaire score
    Substudy: mononuclear cell activity ex vivo measured as IL-6 and IL-10 production upon LPS stimulation.
    Quality of recovery (QoR-40) vragenlijst score
    Substudie: mononucleaire cell activiteit ex-vivo gemeten als IL-6 en IL-10 productie na LPS stimulatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours after surgery
    24 uur postoperatief
    E.5.2Secondary end point(s)
    • Quality of recovery-40 questionnaire score
    • McGill Pain questionnaire
    • RAND-36 general health questionnaire
    • Pain at rest and pain on movement (NRS 0-10), is pain acceptable or unacceptable, referred shoulder pain yes/no
    • Postoperative nausea and vomiting (NRS 0-10)
    • Cumulative opiate, analgesic and anti-emetics use
    • Length of hospital stay
    • Post-operative complications
    • Surgical conditions; the Surgical Rating Scale is used to quantify the quality of the surgical field during the pneumoperitoneum phase
    • Time to reach discharge criteria

    Substudy:
    • Peritoneal mesothelial hypoxia as reflected by peritoneal HIF1α mRNA expression.
    • Histological peritoneal mesothelial cell injury and plasma levels of DAMPs and cytokines.
    • Quality of recovery-40 vragenlijst score postoperatief dag 3 en 7
    • McGill Pijn vragenlijst bij opname en 3 maanden postoperatief
    • RAND-36 algemene gezondheid vragenlijst bij opname en 3 maanden postoperatief
    • Pijn in rust en in beweging (NRS 0-10) 1, 8, 24 en 72 uur postoperatief
    • Is de pijn acceptabel ja/nee 1, 8, 24 en 72 uur postoperatief
    • Uitstralende schouderpijn ja/nee 1, 8, 24 en 72 uur postoperatief
    • Postoperatieve misselijkheid en braken (NRS 0-10) 1, 8, 24 en 72 uur postoperatief
    • Cumulatief opiaat-, pijnstilling- en anti-emetica gebruik
    • Opnameduur
    • Postoperatieve complicaties
    • Chirurgische condities middels de Leiden Surgical Rating Scale
    • Tijd tot bereiken van ontslagcriteria

    Substudie:
    • Peritoneale mesotheliale hypoxie: HIF1α mRNA expression.
    • Histologische peritoneale mesotheliale cellschade en plasma DAMPs en cytokines.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Quality of recovery-40 questionnaire score day 3 and 7 after surgery
    • McGill Pain and RAND-36 questionnaires upon admission and 3 months after surgery.
    • Pain scores, nausea and vomiting 1, 8, 24 and 72 hours after surgery
    • Cumulative opiate, analgesic and anti-emetics use and length of hospital stay at discharge
    • Post-operative complications after 3 months
    • Surgical conditions during pneumoperitoneum
    • Time to reach discharge criteria at 8, 24, 48 and 72 hours after surgery

    Substudy:
    • Peritoneal mesothelial hypoxia: HIF1α mRNA expression before and after pneumoperitoneum phase.
    • Histological peritoneal mesothelial cell injury before and after pneumoperitoneum phase, plasma DAMPs and cytokines upon admission, before and after pneumoperitoneum and 24h after surgery.
    • Quality of recovery-40 vragenlijst score postoperatief dag 3 en 7
    • McGill Pijn en RAND-36 vragenlijst bij opname en 3 maanden postoperatief
    • Pijnscores, misselijkheid en braken 1, 8, 24 en 72 uur postoperatief
    • Cumulatief opiaat-, pijnstilling- en anti-emetica gebruik, en opnameduur bij ontslag
    • Postoperatieve complicaties
    • Chirurgische condities middels de Leiden Surgical Rating Scale
    • Tijd tot bereiken van ontslagcriteria

    Substudie:
    • Peritoneale mesotheliale hypoxie: HIF1α mRNA expression voor en na pneumoperitoneum.
    • Histologische peritoneale mesotheliale cellschade voor en na pneumoperitoneum en plasma DAMPs en cytokines bij opname, voor en na pneumoperitoneum en 24 uur postoperatief.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Laatste bezoek van laatste patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 204
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state204
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Geen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-03
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