NCT03572413

Brief Summary

Substudy of the RECOVER trial (a randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery) investigating innate immune homeostasis after laparoscopic colorectal surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 24, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

June 18, 2018

Last Update Submit

October 27, 2021

Conditions

PneumoperitoneumNeuromuscular BlockadeSurgeryImmune Suppression

Keywords

Laparoscopic surgeryDeep neuromuscular blockLow pressure pneumoperitoneumPostoperative immune suppression

Outcome Measures

Primary Outcomes (1)

  • Mononuclear cell responsiveness ex vivo

    TNFalpha release upon LPS stimulation

    Before surgery, 24 and 72 hours after surgery

Secondary Outcomes (4)

  • Mononuclear cell responsiveness ex-vivo

    Before surgery, 24 and 72 hours after surgery

  • Serum DAMPs and cytokines

    Before surgery, at the end of surgery and 24 hours after surgery

  • HLA-DR mRNA expression

    Before surgery, 24 and 72 hours after surgery

  • Peritoneal histology and HIF1alpha expression

    At the start and end of surgery

Study Arms (2)

Low pressure PNP, deep NMB

EXPERIMENTAL

Low pressure pneumoperitoneum of 8 mmHg with deep neuromuscular block (post tetanic count of 1-2) reached by titration with continuous infusion of Rocuronium bromide.

Procedure: Low pressure pneumoperitoneumDrug: Rocuronium bromide

Normal pressure PNP, moderate NMB

ACTIVE COMPARATOR

Normal pressure pneumoperitoneum of 12 mmHg with moderate neuromuscular block (TOF count of 1-2) reached by titration with bolus or continuous infusion of a low dose of Rocuronium bromide.

Drug: Rocuronium bromide

Interventions

Low pressure pneumoperitoneumPROCEDURE

Lowering intra-abdominal pressure during laparoscopic surgery

Also known as: Low intra-abdominal pressure
Low pressure PNP, deep NMB
Rocuronium bromideDRUG

Deep (PTC 1-2) versus moderate (TOF count 1-2) neuromuscular block

Also known as: Deep muscle relaxation
Low pressure PNP, deep NMBNormal pressure PNP, moderate NMB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for laparoscopic colorectal surgery with a primary anastomosis
  • Obtained informed consent
  • Age over 18 years

You may not qualify if:

  • Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
  • Primary colostomy
  • Neo-adjuvant chemotherapy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, 6532SZ, Netherlands

Location

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kim I Albers, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Michiel C Warlé, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2018

First Posted

June 28, 2018

Study Start

October 24, 2018

Primary Completion

August 31, 2020

Study Completion

December 1, 2020

Last Updated

November 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)