N/A
N=16
Validation of a Subjective Rating Scale for Assessment of the Surgical Workspace in Laparoscopy
Hernia, Inguinal
Bottom Line
View on ClinicalTrials.gov: NCT02545270 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Inter-rater Agreement, 5-point Scale — 0.57 ICC
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Level of pneumoperitoneum 12-9-6 mmHg (Procedure); Level of pneumoperitoneum 11-8-5 mmHg (Procedure); Level of pneumoperitoneum 10-7-4 mmHg (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Herlev Hospital
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inter-rater Agreement, 5-point Scale |
0.57 | — |
| SECONDARY Inter-rater Agreement, 10-point Scale |
0.54 | — |
| SECONDARY Agreement Between the Two Rating Scales Will be Tested With Regression Analysis Using Spearman Correlation Coefficient |
0.79 | — |
| SECONDARY Intra-rater Agreement of Both Rating Scales. |
0.78; 0.84 | — |
Summary
It is of great importance to obtain optimal surgical conditions for the surgeon in order to increase patient safety. The effect of different interventions on surgical conditions has been assessed by various surgeon-assessed rating scales. A 5-point surgical rating scale has previously been tested in a proof-of-concept trial - but not validated - during radical retropubic prostatectomy by asking different surgeons to evaluate the surgical workspace using video sequences.
In an ongoing study (The Hernia Study, Trial registration NCT02247466) performed by investigators group, investigators are using a 5-point scale to rate the surgical workspace during laparoscopic ventral herniotomy with or without neuromuscular blockade. This scale is based on previously used scales by already published studies and has a description connected to each point. To the authors' knowledge the scale has never been validated in a laparoscopic setting, where the intra-abdominal pressure during pneumoperitoneum can have a great influence on visualization. In fact, to investigators knowledge, no validated surgeon-assessed rating scale regarding the surgical workspace during laparoscopic surgery does exists.
Purpose:
Primary aim:
To validate a 5-point rating scale by investigating the inter-rater agreement of evaluations of the surgical workspace at different intra-abdominal pressures. Using intra-abdominal video recordings.
Secondary aims:
To validate a 10-point rating scale by investigating the inter-rater agreement of evaluations of the surgical workspace at different intra-abdominal pressures.
To test the agreement between the two rating scales. To assess which of the two rating scales has the highest inter-rater agreement To assess the intra-rater agreement of both rating scales.
Hypothesis:
Investigators hypothesize that the 5-point rating scale has an intra-class correlation coefficient (ICC) > 0.6., validated by video-sequences obtained during laparoscopic surgery.
Eligibility Criteria
Inclusion Criteria
- Patients ≥ 18 years old
- Elective laparoscopic inguinal herniotomy.
- Can read and understand Danish
Exclusion Criteria
- Technical difficulties making video recording impossible.
Data sourced from ClinicalTrials.gov (NCT02545270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.