Hernia, InguinalNCT02545270
Validation of a Subjective Rating Scale for Assessment of the Surgical Workspace in Laparoscopy
A study testing Level of pneumoperitoneum 12-9-6 mmHg, Level of pneumoperitoneum 11-8-5 mmHg and Level of pneumoperitoneum 10-7-4 mmHg in people with Hernia, Inguinal, run by Herlev Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Level of pneumoperitoneum 12-9-6 mmHg, Level of pneumoperitoneum 11-8-5 mmHg and Level of pneumoperitoneum 10-7-4 mmHg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old
- Elective laparoscopic inguinal herniotomy.
- Can read and understand Danish
Who cannot join
- Technical difficulties making video recording impossible.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Herlev Hospital
Copenhagen
Gentofte Hospital
Hellerup, Capital Region, 2900
About this study
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.
Read more
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.
Read the detailed description
Scales:
The 5-point scale used to assess the surgical workspace during laparoscopic herniotomy:
- (Extremely poor conditions) Unable to complete surgery without interventions*
- (Poor conditions) Several minor adjustments needed to complete surgery. (ie. changes in patient positioning, surgeon position)
- (Acceptable conditions) After few minor adjustments surgery can be completed.
- (Good conditions) Surgical workspace is good, but there is some interference, but no need for adjustments.
- (Optimal conditions) Surgical workspace is optimal and procedure can be completed without any interference.
- Interventions are defined as change in depth of neuromuscular blockade and/or pneumoperitoneum.
The 10-point scale used to assess the surgical workspace during laparoscopic herniotomy is a Visual Analog Scale, where the surgeon specify their rating of the surgical workspace by indicating a position along a continuous line between two end-points
Video recordings:
Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under different levels of pneumoperitoneum during desufflation after surgery is completed.
Each video-sequence will last 20-30 seconds and. three video-sequences during different levels of pneumoperitoneum will be made from each patient. The patients are randomized to one of three groups regarding level of pneumoperitoneum during the three video-recordings. Group 1: 12-9-6 mmHg, 2: 11-8-5, 3: 10-7-4 mmHg. Three video-sequences during different levels of pneumoperitoneum (according to group allocation) will be made from each patient.
We will record 5 pilot video-sequences and have them evaluated by two experienced surgeons in order to design a standard setup for filming the surgical workspace.
From the 30 recorded video-sequences investigators will choose the 24 video-sequences best illustrating different levels of surgical workspace.
The video-sequences will be embedded in an internet form, and each sequence is followed by a question about the rating of that particular surgical workspace.
Each surgeon will be presented to the 24 sequences in a randomly selected recordings of different patients. After each recording the surgeon will evaluate the surgical work space on one of the two rating scales. After rating all recordings, using one scale, the recordings will repeat in a random order and the second scale should be used. When doing the assessment the surgeon should imagine that he/she is about to do a laparoscopic inguinal herniotomy, and the evaluation/rating is based on this situation.
The surgeons are not allowed to discuss their ratings with each other during the study.
To observe intra-rater agreement the surgeon will assess the same sequence at least twice using the same rating scale. Therefore the surgeons will see all recordings four times during the study.
Sample size requirements are calculated by estimating the width of the confidence interval(CI) as described by Shoukri et all. An ICC of 0.8 with a 95% CI of [0.6-1.0] can be achieved with 8 surgeons assessing 24 recordings. To ensure sufficient variation in the recordings investigators will include a total of 10 patients and make three recordings from each.
Sample size requirements are calculated by estimating the width of the confidence interval(CI) as described by Shoukri et all. An ICC of 0.8 with a 95% CI of [0.6-1.0] can be achieved with 8 surgeons assessing 24 recordings. To ensure sufficient variation in the recordings we will include a total of 10 patients and make three recordings from each. Investigators assume that the 24 recordings can be seen as 24 independent subjects.
Both the inter-rater agreement and the intra-rater agreement will be calculated using Kappa and intraclass correlation statistics. with statistical software6. The model for ICC will be a two-way random, single measures, absolute agreement, ( ICC(2,1) ) Calculated using SPSS (ver 22.0).
The agreement between the two rating scales will be tested with regression analysis using Spearman correlation coefficient.
To assess which of the two rating scales that has the highest inter-rater agreement the two scales corresponding ICC with confidence intervals will be compared.
Investigator and co-authors will be responsible for analyzing the study data with assistance from Statistician located at Herlev Hospital.
Investigators will include 8 surgeons (Specialist level of training and proficient in laparoscopic inguinal surgery).
- Conditions
- Hernia, Inguinal
- Being tested
- Level of pneumoperitoneum 12-9-6 mmHg, Level of pneumoperitoneum 11-8-5 mmHg, Level of pneumoperitoneum 10-7-4 mmHg
- Keywords
- Surgery, Laparoscopic, surgical rating scale
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level of pneumoperitoneum 12-9-6 mmHgProcedure or surgery
Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation.
Level of pneumoperitoneum 11-8-5 mmHgProcedure or surgery
Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation.
Level of pneumoperitoneum 10-7-4 mmHgProcedure or surgery
Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 12-9-6 mmHg | Experimental | Elective 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. Receives: Procedure: Level of pneumoperitoneum 12-9-6 mmHg |
| Group 2: 11-8-5 mmHg | Experimental | Elective 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. Receives: Procedure: Level of pneumoperitoneum 11-8-5 mmHg |
| Group 3: 10-7-4 mmHg | Experimental | Elective 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. Receives: Procedure: Level of pneumoperitoneum 10-7-4 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 min
Secondary outcomes (3)
Inter-rater Agreement, 10-point Scale
To validate a 10-point rating scale by investigating the inter-rater agreement of evaluations of the surgical workspace at different intra-abdominal pressures. The inter-rater agreement will be calculated using intraclass correlation statistics with statistical software.
The 10-point rating scale was a discrete numerical scale with 1 being worst possible surgical workspace and 10 being best possible.
Measured: 60 min
Agreement Between the Two Rating Scales Will be Tested With Regression Analysis Using Spearman Correlation Coefficient
The agreement between the two rating scales 5-point categorical and 10-point numerical will be tested with regression analysis using Spearman correlation coefficient
Measured: 60 min
Intra-rater Agreement of Both Rating Scales.
To assess the intra-rater agreement of both rating scales, 10-point numerical and 5-point categorical scale.
The intra-rater agreement will be calculated using intraclass correlation statistics.
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startMar 2016
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Roar Medici, Herlev Hospital
- Investigators
- Roar Medici, MD, Principal investigator, Herlev Hospital University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545270
- Sponsor's protocol ID
- Vallap01
- Status last verified
- Mar 2019
- First submitted
- 6 Aug 2015
- Last updated
- 17 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Subjective Rating Scale for Assessment of the Surgical Workspace in Laparoscopy
- ClinicalTrials.gov ID
- NCT02545270
- Acronym / sponsor ID
- Vallap01
- Conditions
- Hernia, Inguinal
- Keywords
- Surgery, Laparoscopic, surgical rating scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Posted 17 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Scales:
The 5-point scale used to assess the surgical workspace during laparoscopic herniotomy:
- (Extremely poor conditions) Unable to complete surgery without interventions*
- (Poor conditions) Several minor adjustments needed to complete surgery. (ie. changes in patient positioning, surgeon position)
- (Acceptable conditions) After few minor adjustments surgery can be completed.
- (Good conditions) Surgical workspace is good, but there is some interference, but no need for adjustments.
- (Optimal conditions) Surgical workspace is optimal and procedure can be completed without any interference.
- Interventions are defined as change in depth of neuromuscular blockade and/or pneumoperitoneum.
The 10-point scale used to assess the surgical workspace during laparoscopic herniotomy is a Visual Analog Scale, where the surgeon specify their rating of the surgical workspace by indicating a position along a continuous line between two end-points
Video recordings:
Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under different levels of pneumoperitoneum during desufflation after surgery is completed.
Each video-sequence will last 20-30 seconds and. three video-sequences during different levels of pneumoperitoneum will be made from each patient. The patients are randomized to one of three groups regarding level of pneumoperitoneum during the three video-recordings. Group 1: 12-9-6 mmHg, 2: 11-8-5, 3: 10-7-4 mmHg. Three video-sequences during different levels of pneumoperitoneum (according to group allocation) will be made from each patient.
We will record 5 pilot video-sequences and have them evaluated by two experienced surgeons in order to design a standard setup for filming the surgical workspace.
From the 30 recorded video-sequences investigators will choose the 24 video-sequences best illustrating different levels of surgical workspace.
The video-sequences will be embedded in an internet form, and each sequence is followed by a question about the rating of that particular surgical workspace.
Each surgeon will be presented to the 24 sequences in a randomly selected recordings of different patients. After each recording the surgeon will evaluate the surgical work space on one of the two rating scales. After rating all recordings, using one scale, the recordings will repeat in a random order and the second scale should be used. When doing the assessment the surgeon should imagine that he/she is about to do a laparoscopic inguinal herniotomy, and the evaluation/rating is based on this situation.
The surgeons are not allowed to discuss their ratings with each other during the study.
To observe intra-rater agreement the surgeon will assess the same sequence at least twice using the same rating scale. Therefore the surgeons will see all recordings four times during the study.
Sample size requirements are calculated by estimating the width of the confidence interval(CI) as described by Shoukri et all. An ICC of 0.8 with a 95% CI of [0.6-1.0] can be achieved with 8 surgeons assessing 24 recordings. To ensure sufficient variation in the recordings investigators will include a total of 10 patients and make three recordings from each.
Sample size requirements are calculated by estimating the width of the confidence interval(CI) as described by Shoukri et all. An ICC of 0.8 with a 95% CI of [0.6-1.0] can be achieved with 8 surgeons assessing 24 recordings. To ensure sufficient variation in the recordings we will include a total of 10 patients and make three recordings from each. Investigators assume that the 24 recordings can be seen as 24 independent subjects.
Both the inter-rater agreement and the intra-rater agreement will be calculated using Kappa and intraclass correlation statistics. with statistical software6. The model for ICC will be a two-way random, single measures, absolute agreement, ( ICC(2,1) ) Calculated using SPSS (ver 22.0).
The agreement between the two rating scales will be tested with regression analysis using Spearman correlation coefficient.
To assess which of the two rating scales that has the highest inter-rater agreement the two scales corresponding ICC with confidence intervals will be compared.
Investigator and co-authors will be responsible for analyzing the study data with assistance from Statistician located at Herlev Hospital.
Investigators will include 8 surgeons (Specialist level of training and proficient in laparoscopic inguinal surgery).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: 12-9-6 mmHg | Experimental | Procedure: Level of pneumoperitoneum 12-9-6 mmHgElective 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 | Experimental | Procedure: Level of pneumoperitoneum 11-8-5 mmHgElective 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 | Experimental | Procedure: Level of pneumoperitoneum 10-7-4 mmHgElective 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 18 years old
- Elective laparoscopic inguinal herniotomy.
- Can read and understand Danish
Key exclusion criteria (1 listed)
- Technical difficulties making video recording impossible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Level of pneumoperitoneum 12-9-6 mmHgElective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation. | Procedure or surgery | Group 1: 12-9-6 mmHg |
| Level of pneumoperitoneum 11-8-5 mmHgElective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation. | Procedure or surgery | Group 2: 11-8-5 mmHg |
| Level of pneumoperitoneum 10-7-4 mmHgElective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation. | Procedure or surgery | Group 3: 10-7-4 mmHg |
Primary outcome
Inter-rater Agreement, 5-point Scale
Time frame: 60 min
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.
3 secondary outcomes
Inter-rater Agreement, 10-point Scale
Time frame: 60 min
Agreement Between the Two Rating Scales Will be Tested With Regression Analysis Using Spearman Correlation Coefficient
Time frame: 60 min
Intra-rater Agreement of Both Rating Scales.
Time frame: 60 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roar Medici, MD principal investigator
Herlev Hospital University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Level of pneumoperitoneum 12-9-6 mmHg, Level of pneumoperitoneum 11-8-5 mmHg and Level of pneumoperitoneum 10-7-4 mmHg in people with Hernia, Inguinal, run by Herlev Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater Agreement, 5-point Scale (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.