Validation of a Subjective Rating Scale for Assessment of the Surgical Workspace in Laparoscopy
1 other identifier
interventional
16
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
June 17, 2019
CompletedJune 17, 2019
March 1, 2019
4 months
August 6, 2015
March 20, 2018
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inter-rater Agreement, 5-point Scale
To validate a 5-point rating scale by investigating the inter-rater agreement of evaluations of the surgical workspace at different intra-abdominal pressures. The 5-point surgical rating scale is categorical, with following descriptions: 1 (Extremely poor conditions) Unable to complete surgery without interventions 2 (Poor conditions) Several minor adjustments needed to complete surgery. (e.g. changes in patient body position, surgeon position) 3 (Acceptable conditions) After few minor adjustments surgery can be completed. 4 (Good conditions) Surgical workspace is good, but there is some interference, but no need for adjustments. 5 (Optimal conditions) Surgical workspace is optimal and procedure can be completed without any interference. Using intra-abdominal video recordings. The inter-rater agreement will be calculated using intraclass correlation statistics with statistical software.
60 min
Secondary Outcomes (3)
Inter-rater Agreement, 10-point Scale
60 min
Agreement Between the Two Rating Scales Will be Tested With Regression Analysis Using Spearman Correlation Coefficient
60 min
Intra-rater Agreement of Both Rating Scales.
60 min
Study Arms (3)
Group 1: 12-9-6 mmHg
EXPERIMENTALElective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation after surgery is completed.
Group 2: 11-8-5 mmHg
EXPERIMENTALElective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation after surgery is completed.
Group 3: 10-7-4 mmHg
EXPERIMENTALElective laparoscopic inguinal hernia procedures will be used to make three video-recordings (lasting 20-30 seconds) under different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation after surgery is completed.
Interventions
Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation.
Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation.
Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation.
Eligibility Criteria
You may qualify if:
- Patients ≥ 18 years old
- Elective laparoscopic inguinal herniotomy.
- Can read and understand Danish
You may not qualify if:
- Technical difficulties making video recording impossible.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (2)
Gentofte Hospital
Hellerup, Capital Region, 2900, Denmark
Herlev Hospital
Copenhagen, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- MD. G. G. Nervil
- Organization
- Department of Anesthesiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Roar Medici, MD
Herlev Hospital University of Copenhagen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant, MD.
Study Record Dates
First Submitted
August 6, 2015
First Posted
September 9, 2015
Study Start
March 1, 2016
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
June 17, 2019
Results First Posted
June 17, 2019
Record last verified: 2019-03