E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The purpose of this study is to investigate surgical work space and surgical conditions in patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The patients will act as their own control with evaluation of surgical work space and surgical conditions during both deep NMB and no NMB. |
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E.1.1.1 | Medical condition in easily understood language |
To evaluate if musclerelaxation gives better overview and surgical conditions in patients scheduled for hernia surgery with laparoscope |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019909 |
E.1.2 | Term | Hernia |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary outcome: Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg.
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E.2.2 | Secondary objectives of the trial |
-Surgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale) -Duration of operating time (from first incision to last suture) -Duration of suturing the hernia (minutes) -Assessments if the surgical space is better, unchanged or worse when evaluating before and after the intervention -Number of sudden contractions of the abdominal wall during operation (bucking or coughing), -Number of insufflator alarms where pneumoperitoneum > 17 mmHg, -Number of episodes with continuous abdominal contractions where the abdomen feels ”tight” but the operation can still proceed (the intestines are gradually displaced near the inner surface of the abdominal wall). - Number of recurrences of hernias by 2 year follow-up (separate publication).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients > 18 years old Elective laparoscopic umbilical herniotomy, incisional herniotomy and linea alba herniotomy Can read and understand Danish Informed consent
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E.4 | Principal exclusion criteria |
Known allergy to sugammadex or rocuronium Severe renal disease, defined by S-creatinine> 0.200 mmol/L, GFR < 30ml/min or hemodialysis) Neuromuscular disease that may interfere with neuromuscular data Lactating or pregnant Indication for rapid sequence induction
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary outcomes: (comparing Group A with Group B) -Surgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale) -Duration of operating time (from first incision to last suture) -Duration of suturing the hernia (minutes) -Assessments if the surgical space is better, unchanged or worse when evaluating before and after the intervention -Number of sudden contractions of the abdominal wall during operation (bucking or coughing), -Number of insufflator alarms where pneumoperitoneum > 17 mmHg, -Number of episodes with continuous abdominal contractions where the abdomen feels ”tight” but the operation can still proceed (the intestines are gradually displaced near the inner surface of the abdominal wall). - Number of recurrences of hernias by 2 year follow-up (separate publication).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During operation and 2 years after surgery |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |