The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis.
NCT03572413 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2021-11-03
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.
Conditions
- Pneumoperitoneum
- Neuromuscular Blockade
- Surgery
- Immune Suppression
Interventions
- PROCEDURE
-
Low pressure pneumoperitoneum
Lowering intra-abdominal pressure during laparoscopic surgery
- DRUG
-
Rocuronium bromide
Deep (PTC 1-2) versus moderate (TOF count 1-2) neuromuscular block
Sponsors & Collaborators
- collaborator INDUSTRY
-
Radboud University Medical Center
lead OTHER
Principal Investigators
-
Kim I Albers, MD · Radboud University Medical Center
-
Michiel C Warlé, MD, PhD · Radboud University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-24
- Primary Completion
- 2020-08-31
- Completion
- 2020-12-01
Countries
- Netherlands
Study Locations
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