Trial Outcomes & Findings for Mastery Learning Inguinal Hernia Repair (NCT NCT01085500)

Results Overview

Operative time was recorded with a standard stopwatch, began at the start of the operative case and ended when procedure was terminated. We realized that the operative time for poorly performing trainees could be faster than the time for more skilled trainees because the supervising surgeon would perform a greater proportion of the procedure. We calculated participation-corrected time as raw total time + the time of staff involvement: time\_corrected = time\_raw + (1-participation) x time\_raw.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

at first TEP procedure post-randomization; Due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two

Results posted on

2016-10-28

Participant Flow

General surgery residents were recruited from the Mayo Clinic, Rochester, Minnesota from January to September 2010.

Participant milestones

Participant milestones
Measure	Simulation Curriculum General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.	Current Practice General surgery residents will undergo training according to current practice.
Overall Study STARTED	26	24
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mastery Learning Inguinal Hernia Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Simulation Curriculum n=26 Participants General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.	Current Practice n=24 Participants General surgery residents will undergo training according to current practice.	Total n=50 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
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30 years STANDARD_DEVIATION 2 • n=5 Participants	30 years STANDARD_DEVIATION 3 • n=7 Participants	30 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	24 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: at first TEP procedure post-randomization; Due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two

Operative time was recorded with a standard stopwatch, began at the start of the operative case and ended when procedure was terminated. We realized that the operative time for poorly performing trainees could be faster than the time for more skilled trainees because the supervising surgeon would perform a greater proportion of the procedure. We calculated participation-corrected time as raw total time + the time of staff involvement: time\_corrected = time\_raw + (1-participation) x time\_raw.

Outcome measures

Outcome measures
Measure	Simulation Curriculum n=26 Participants General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.	Current Practice n=24 Participants General surgery residents will undergo training according to current practice.
Participation-Corrected Operative Time	34.4 minutes Standard Deviation 8.4	47.5 minutes Standard Deviation 13.9

SECONDARY outcome

Timeframe: at first TEP procedure post-randomization; due to surgical scheduling variability this can be anytime from 1 to 2 days following randomization to a week or two

The trained observer and the staff supervising surgeon graded operative performance independently using a global rating scale, Global Operative Assessment of Laparoscopic Skills (GOALS) immediately after each case, (1 rating per case if bilateral repair). The GOALS tool has been shown to be a valid and reliable tool to measure generic laparoscopic skills in the simulated environment and in the operating room, with good agreement between live and video-review ratings. The scores range from 6 to 30, a higher score indicates greater operative performance.

Outcome measures

Outcome measures
Measure	Simulation Curriculum n=26 Participants General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.	Current Practice n=24 Participants General surgery residents will undergo training according to current practice.
Operative Performance	21.9 units on a scale Standard Deviation 2.7	18.3 units on a scale Standard Deviation 3.8

SECONDARY outcome

Timeframe: at first TEP procedure post-randomization, subjects were followed for the duration of hospital stay, an average of 1 night

Urinary retention is the inability to empty the bladder. This is an educational study for surgeons. The participants in the study are surgeons, and the participant flow, baseline characteristics and first two outcome measures are for the surgeons. During the part of the study reported for the third outcome measure, the first surgical procedure (TEP) after randomization, each surgeon had one subject. Therefore, this outcome measure is for the hernia patients or subjects.

Outcome measures

Outcome measures
Measure	Simulation Curriculum n=26 Participants General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.	Current Practice n=24 Participants General surgery residents will undergo training according to current practice.
Number of Hernia Repair Subjects With Post-Operative Urinary Retention	0 Subjects	9 Subjects

Adverse Events

Current Practice

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Simulation Curriculum

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Current Practice n=24 participants at risk General surgery residents will undergo training according to current practice.	Simulation Curriculum n=26 participants at risk General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
Musculoskeletal and connective tissue disorders Peritoneal tear	37.5% 9/24 • Number of events 9 • Adverse events were collected on all patients during the hernia operation and postoperative until release from the hospital for first hernia repair postrandomization.	3.8% 1/26 • Number of events 1 • Adverse events were collected on all patients during the hernia operation and postoperative until release from the hospital for first hernia repair postrandomization.
Gastrointestinal disorders Epigastric vessel injury	16.7% 4/24 • Number of events 4 • Adverse events were collected on all patients during the hernia operation and postoperative until release from the hospital for first hernia repair postrandomization.	3.8% 1/26 • Number of events 1 • Adverse events were collected on all patients during the hernia operation and postoperative until release from the hospital for first hernia repair postrandomization.
Renal and urinary disorders Urinary Retention	37.5% 9/24 • Number of events 9 • Adverse events were collected on all patients during the hernia operation and postoperative until release from the hospital for first hernia repair postrandomization.	0.00% 0/26 • Adverse events were collected on all patients during the hernia operation and postoperative until release from the hospital for first hernia repair postrandomization.
Skin and subcutaneous tissue disorders Hematoma	8.3% 2/24 • Number of events 2 • Adverse events were collected on all patients during the hernia operation and postoperative until release from the hospital for first hernia repair postrandomization.	3.8% 1/26 • Number of events 1 • Adverse events were collected on all patients during the hernia operation and postoperative until release from the hospital for first hernia repair postrandomization.
Skin and subcutaneous tissue disorders Superficial skin infection	8.3% 2/24 • Number of events 2 • Adverse events were collected on all patients during the hernia operation and postoperative until release from the hospital for first hernia repair postrandomization.	0.00% 0/26 • Adverse events were collected on all patients during the hernia operation and postoperative until release from the hospital for first hernia repair postrandomization.

Additional Information

Benjamin Zendejas, MD

Mayo Clinic

Phone: 507-538-5413

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place