Resident surgical laparoscopic salpingectomy training: a randomized controlled trial
| ISRCTN | ISRCTN48561230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48561230 |
| Secondary identifying numbers | CCC #33254 |
- Submission date
- 18/06/2015
- Registration date
- 09/07/2015
- Last edited
- 07/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
This study investigates whether a single session of practicing surgical techniques on a porcine (pig) cadaver improves Ob-Gyn resident (medical student) surgical skills.
Who can participate?
All PGY-1 through PGY-4 Ob/Gyn residents at Christiana Care Hospital.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention) attend a session involving pre-session reading, a lecture, viewing a procedural video and then practicing a surgical procedure (laparoscopic salpingectomy) on a porcine cadaver. Those in group 2 (control) receive traditional training. All participants undergo on-site assessment and training (OSAT) before and after the training session. They are also asked to fill in surveys before and after the session to assess their comfort levels.
What are the possible benefits and risks of participating?
A potential benefit of the study is that simulation may improve surgical technique.
Where is the study run from?
Christiana Care Hospital, Newark (USA)
When is the study starting and how long is it expected to run for?
December 2013 to January 2014
Who is funding the study?
Christiana Care Hospital, Newark (USA)
Who is the main contact?
Dr Nima Patel
Contact information
Scientific
4755 Ogletown-Stanton Rd., Suite 1905, Dept. OB/GYN
Newark
19707
United States of America
 ORCID ID |
0000-0003-4526-4432 |
|---|
Study information
| Study design | Single blinded (evaluator) single center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Traditional versus simulation resident surgical laparoscopic salpingectomy training: a randomized controlled trial |
| Study objectives | We conducted a randomized controlled trial to examine whether a single session of simulated practice of surgical techniques utilizing a porcine cadaver improved Ob-Gyn resident surgical skills. The study’s primary hypothesis was formal training including video observation followed by a single session of procedural simulation in a porcine cadaver model would improve laparoscopic salpingectomy performance compared with traditional training methods. |
| Ethics approval(s) | Christiana Care Hospital Institutional Review Board, 11/29/2013, ref: CCC #33254 |
| Health condition(s) or problem(s) studied | Traditional versus simulation resident surgical laparoscopic salpingectomy training |
| Intervention | 1. The intervention group participated in a training module of assigned pre-session reading on pelvic anatomy from a gynecology textbook and a designated article on ultrasonic energy and a formal 3 hour simulation session. The simulation session included a 40-minute didactic introduction reviewing indications for, and the benefits of, laparoscopic salpingectomy and review of relevant anatomy and analogous structures between human and porcine models. It also outlined the fundamental steps of laparoscopic salpingectomy; reviewed the advanced Bipolar or ultrasonic energy sources used; and a video review of a simulated porcine model laparoscopic salpingectomy performed at our institution. Following this didactic presentation, participants had 60 minutes to familiarize themselves with and practice using instrumentation. Participants were then paired to each engage in a 30-minute simulation of laparoscopic tubal salpingectomy on a porcine cadaver model. During this time, each trainee performed a unilateral salpingectomy on the model. An experienced laparoscopist was present to give direction and feedback to participants during the simulation session to facilitate their training in instrumentation and on procedure performance. 2. The control group was not assigned any of the reading, educational activities or simulation session of the intervention group. They continued standard residency training of surgical skills. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The primary outcomes are the OSAT scores, based on a multi-item assessment that measures 9 aspects of surgical technique. Each item is rated from 1-5 using a Likert scale where 1 signifies a low and 5 a high score. For this study, the minimum score on the OSAT was 5 and the maximum achievable score was 45. This instrument has acceptable internal reliability (there was a single evaluator) and its validity is supported through correlations with conceptually related measures from a previously validated surgical skills Global Rating Scale. |
| Secondary outcome measures | Resident comfort level with laparoscopic surgical salpingectomy |
| Overall study start date | 19/12/2013 |
| Completion date | 13/01/2014 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 22 |
| Total final enrolment | 22 |
| Key inclusion criteria | All PGY-1 through PGY-4 Ob/Gyn residents at Christiana Care Hospital |
| Key exclusion criteria | Unable to complete OSAT evaluation |
| Date of first enrolment | 19/12/2013 |
| Date of final enrolment | 13/01/2014 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Room 1903
Newark
19718
United States of America
Sponsor information
Hospital/treatment centre
4755 Ogletown-Stanton Rd., Suite 1905, Dept of OB/GYN
Newark
19707
United States of America
"ROR" |
https://ror.org/02h905004 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The study has been presented at the 2014 Advancing Minimally Invasive Gynecology meeting. It is planned to publish the results in an internationally available refereed gynecology or medical education journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2016 | 07/08/2019 | Yes | No |
Editorial Notes
07/08/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
