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Trial Outcomes & Findings for Validation of a Subjective Rating Scale for Assessment of the Surgical Workspace in Laparoscopy (NCT NCT02545270)

NCT ID: NCT02545270

Last Updated: 2019-06-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

60 min

Results posted on

2019-06-17

Participant Flow

Participant milestones

Participant milestones
Measure
Group 1: 12-9-6 mmHg
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. Level of pneumoperitoneum 12-9-6 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation.
Group 2: 11-8-5 mmHg
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. Level of pneumoperitoneum 11-8-5 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation.
Group 3: 10-7-4 mmHg
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. Level of pneumoperitoneum 10-7-4 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation.
Overall Study
STARTED
6
5
5
Overall Study
COMPLETED
6
4
3
Overall Study
NOT COMPLETED
0
1
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Group 1: 12-9-6 mmHg
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. Level of pneumoperitoneum 12-9-6 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation.
Group 2: 11-8-5 mmHg
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. Level of pneumoperitoneum 11-8-5 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation.
Group 3: 10-7-4 mmHg
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. Level of pneumoperitoneum 10-7-4 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation.
Overall Study
technical difficulties
0
1
0
Overall Study
Videos being too similar to other
0
0
2

Baseline Characteristics

Validation of a Subjective Rating Scale for Assessment of the Surgical Workspace in Laparoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1: 12-9-6 mmHg
n=6 Participants
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. Level of pneumoperitoneum 12-9-6 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation.
Group 2: 11-8-5 mmHg
n=5 Participants
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. Level of pneumoperitoneum 11-8-5 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation.
Group 3: 10-7-4 mmHg
n=5 Participants
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. Level of pneumoperitoneum 10-7-4 mmHg: Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation.
Total
n=16 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
6 Participants
n=4 Participants
Age, Categorical
>=65 years
6 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
10 Participants
n=4 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
5 Participants
n=7 Participants
5 Participants
n=5 Participants
15 Participants
n=4 Participants
Region of Enrollment
Denmark
6 Participants
n=5 Participants
5 Participants
n=7 Participants
5 Participants
n=5 Participants
16 Participants
n=4 Participants
ASA score
ASA 1
4 Participants
n=5 Participants
3 Participants
n=7 Participants
3 Participants
n=5 Participants
10 Participants
n=4 Participants
ASA score
ASA 2
2 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
6 Participants
n=4 Participants
Neuromuscular blockade used
Neurosmuscular blockade used
3 Participants
n=5 Participants
3 Participants
n=7 Participants
0 Participants
n=5 Participants
6 Participants
n=4 Participants
Neuromuscular blockade used
Neurosmuscular blockade NOT used
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
10 Participants
n=4 Participants
Type of anesthesia
TIVA
5 Participants
n=5 Participants
5 Participants
n=7 Participants
5 Participants
n=5 Participants
15 Participants
n=4 Participants
Type of anesthesia
Not TIVA
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 60 min

Population: The 24 videos recorded from 13 participants.

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.

Outcome measures

Outcome measures
Measure
Surgeons Assessing Video Sequences
n=24 Videos
7 experienced surgeons recruited: Specialist level of training Performed \>200 laparoscopic cholecystectomies
Surgeons Assessing Video Sequences 10-point Scale
7 experienced surgeons recruited: Specialist level of training Performed \>200 laparoscopic cholecystectomies
Inter-rater Agreement, 5-point Scale
0.57 ICC
Interval 0.45 to 0.69
—

SECONDARY outcome

Timeframe: 60 min

Population: The 24 videos recorded from 13 participants.

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.

Outcome measures

Outcome measures
Measure
Surgeons Assessing Video Sequences
n=24 Videos
7 experienced surgeons recruited: Specialist level of training Performed \>200 laparoscopic cholecystectomies
Surgeons Assessing Video Sequences 10-point Scale
7 experienced surgeons recruited: Specialist level of training Performed \>200 laparoscopic cholecystectomies
Inter-rater Agreement, 10-point Scale
0.54 ICC
Interval 0.39 to 0.58
—

SECONDARY outcome

Timeframe: 60 min

Population: Agreement between the two rating scales ( 5-poit categorical and 10-point numerical) used to assess the 24 videos recorded from 13 participants.

The agreement between the two rating scales 5-point categorical and 10-point numerical will be tested with regression analysis using Spearman correlation coefficient

Outcome measures

Outcome measures
Measure
Surgeons Assessing Video Sequences
n=2 Scales
7 experienced surgeons recruited: Specialist level of training Performed \>200 laparoscopic cholecystectomies
Surgeons Assessing Video Sequences 10-point Scale
7 experienced surgeons recruited: Specialist level of training Performed \>200 laparoscopic cholecystectomies
Agreement Between the Two Rating Scales Will be Tested With Regression Analysis Using Spearman Correlation Coefficient
0.79 Spearman correlation coefficient
Interval 0.56 to 0.9
—

SECONDARY outcome

Timeframe: 60 min

Population: Intra-rater agreement of both scales ( 5-poit categorical and 10-point numerical) used to assess the 24 videos recorded from 13 participants.

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.

Outcome measures

Outcome measures
Measure
Surgeons Assessing Video Sequences
n=13 Participants
7 experienced surgeons recruited: Specialist level of training Performed \>200 laparoscopic cholecystectomies
Surgeons Assessing Video Sequences 10-point Scale
n=13 Participants
7 experienced surgeons recruited: Specialist level of training Performed \>200 laparoscopic cholecystectomies
Intra-rater Agreement of Both Rating Scales.
0.78 ICC
Interval 0.71 to 0.84
0.84 ICC
Interval 0.8 to 0.88

Adverse Events

Group 1: 12-9-6 mmHg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 2: 11-8-5 mmHg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 3: 10-7-4 mmHg

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

MD. G. G. Nervil

Department of Anesthesiology, Herlev and Gentofte Hospital, University of Copenhagen, Herlev Denmark

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place