Validation of a Subjective Rating Scale for Assessment of the Surgical Workspace in Laparoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Inter-rater Agreement, 5-point Scale
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old
- •Elective laparoscopic inguinal herniotomy.
- •Can read and understand Danish
排除标准
- •Technical difficulties making video recording impossible.
研究组 & 干预措施
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.
干预措施: Level of pneumoperitoneum 12-9-6 mmHg (Procedure)
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.
干预措施: Level of pneumoperitoneum 11-8-5 mmHg (Procedure)
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.
干预措施: Level of pneumoperitoneum 10-7-4 mmHg (Procedure)
结局指标
主要结局
Inter-rater Agreement, 5-point Scale
时间窗: 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.
次要结局
- 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)
研究者
Roar Medici
Research Assistant, MD.
Herlev Hospital