Fourth Degree Perineal Laceration Involving Anal MucosaNCT03341351
Use of the Modified Beef Tongue Model for Teaching Repair of Obstetrical Fourth-Degree Laceration to Residents
A study testing Instructional video and Instructional workshop in people with Fourth Degree Perineal Laceration Involving Anal Mucosa and Obstetric; Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a study evaluating the use of the modified beef tongue model for teaching repair of obstetrical fourth-degree laceration to residents. Participants will be randomized to either an instructional video using the modified beef tongue model or to an instructional workshop using the modified beef tongue model. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fourth Degree Perineal Laceration Involving Anal Mucosa, Obstetric; Injury, Obstetric Labor Complications
- What is being tested?
- Instructional video and Instructional workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 29 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Residents currently in training program at University of Alabama at Birmingham
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Birmingham Hospital
Birmingham, Alabama, 35233
About this study
Official title: Use of the Modified Beef Tongue Model for Teaching Repair of Obstetrical
This is a study evaluating the use of the modified beef tongue model for teaching repair of obstetrical fourth-degree laceration to residents. Participants will be randomized to either an instructional video using the modified beef tongue model or to an instructional workshop using the modified beef tongue model. Primary outcome will be measured as change in technical skills score as measured by change from baseline on a validated objective structured assessment of technical skills (OSTATS) for repair of fourth-degree laceration.
Read the detailed description
Institutional Review Board approval has been obtained and written informed consent will be obtained prior to initiation of the study. All obstetrics and gynecology residents at the University of Alabama will be eligible for the study.
Eligible residents who desire will be enrolled and consented for the trial. Participants will then complete a short pre-intervention knowledge assessment written test and be asked to rate their confidence level in completing a fourth-degree repair based on a Likert scale. The written test is the same as the one used by Patel et al to evaluate residents' knowledge about fourth-degree laceration repair. The questions are based on Williams's obstetric chapter on episiotomy repair and showed construct validity given a significant difference in scores between postgraduate year (PGY)-1 and PGY-4 residents. Participants will also complete a baseline objective structured assessment of technical skills (OSATS) assessment for repair of fourth-degree obstetric laceration on a commercial anatomical replica, the Sultan Anal Sphincter Trainer (Limbs \& Things Inc, Savannah, Georgia). This model comes with a replaceable perineal pad that allows approximately 24 repairs before replacement is necessary. The validated OSATS used will be the assessment described by Siddiqui et al and validated on a surgical model. The repair will be videotaped and then distributed to evaluators who will use the 20 item task specific checklist described by Siddiqui et al. The time taken for the repair will be recorded.
Demographic and baseline data will be collected on the participants including PGY level, number of fourth-degree lacerations performed, whether they have read a textbook regarding fourth-degree laceration repair, whether they have read a journal article regarding fourth-degree laceration repair, whether they have attended a didactic session in pelvic anatomy, and whether they have attended a didactic session on fourth-degree laceration repair.
Participants will then be randomized into two groups. Randomization will be performed using a computer-generated block design so that each group has a balanced number of residents in each postgraduate year training level. One group will be randomized to the modified beef tongue video and one will be randomized to the modified beef tongue instructional workshop. The modified beef tongue video group will be given an instructional video created using the modified beef tongue model to show anatomy and proper repair of the laceration. The group randomized to the modified beef tongue instructional workshop will undergo an interactive workshop using the modified beef tongue model to show anatomy and proper repair of the laceration.
The modified beef tongue for the video and workshop will be prepared according to the model previously described in the literature. The modified model includes beef tripe (small intestine) used for anal mucosa and chicken leg muscles for anal sphincter muscle analogs. The tripe is tunneled through the body of the trimmed beef tongue and sutured like an ostomy to simulate the anal canal. The tongue is incised toward the tripe "anal canal." Chicken leg muscles are tunneled from the incision out to the cut edges of the beef tongue to create anal sphincter muscle analogs.
Following the didactic intervention, participants from each group will be given the written knowledge assessment test again and the objective structured assessment of technical skills (OSATS) for repair of fourth-degree laceration on the commercial anatomical replica again. The time taken for the repair will be recorded. Residents will also be asked to evaluate model realism, ease of use, and satisfaction using a Likert scale. The residents will be asked to assess their confidence again using a Likert scale.
The participants will then be crossed over and those who were initially randomized to the video group will then undergo the instructional workshop and the ones initially in the workshop group will be given the instructional video. Participants will then be asked to rate their overall preference between models on a scale of 1 to 10 with 1 being the video and 10 being the instructional workshop. They will also complete the written knowledge test again.
The results of this trial may help to inform to a cost- and time-efficient manner of instruction on the repair of 3rd and 4th degree lacerations. A weakness is that it is unclear whether this will translate to effectiveness at the time of an actual third- and fourth-degree repair.
- Conditions
- Fourth Degree Perineal Laceration Involving Anal Mucosa, Obstetric; Injury, Obstetric Labor Complications
- Being tested
- Instructional video, Instructional workshop
- Keywords
- Fourth-degree laceration, Beef tongue model
- Medical subject headings
- Wounds and Injuries, Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructional videoOther
Instructional video using the modified beef tongue model
Instructional workshopOther
Instructional workshop using the modified beef tongue model.
| Study group | Role | What they receive |
|---|---|---|
| Instructional video | Active comparator | The modified beef tongue video group will be given an instructional video created using the modified beef tongue model to show anatomy and proper repair of the laceration. Receives: Other: Instructional video |
| Instructional workshop | Active comparator | The group randomized to the modified beef tongue instructional workshop will undergo an interactive workshop using the modified beef tongue model to show anatomy and proper repair of the laceration. Receives: Other: Instructional workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical skills score
The primary outcome will be change in technical skills score measured as change from baseline in a validated objective structured assessment of technical skills (OSATS) for repair of fourth degree obstetric laceration. This OSATS was described by Siddiqui et al and is based on a task-specific checklist for fourth-degree lacerations and has a maximum score of 20 and minimum score of 0. The higher the score the better the performance.
Measured: up to 24 weeks
Secondary outcomes (8)
Participant preference
Participant preference of model between instructional video and instructional workshop. Participants will be asked to rate their overall preference between models on a scale of 1 to 10 with 1 being the video and 10 being the instructional workshop.
Measured: up to 24 weeks
Knowledge assessment
Knowledge assessed by written test performed pre- and post-intervention. The written test is the same as the one used by Patel et al to evaluate residents' knowledge about fourth-degree laceration repair. The questions are based on Williams's obstetric chapter on episiotomy repair. The test has a minimum score of 0 and maximum score of 17 with a higher score indicating better performance.
Measured: up to 24 weeks
Participant confidence
Participant's confidence in fourth-degree laceration repair as measured by change in confidence score from pre- to post-intervention. This is based on the participant's response to a 10 point Likert scale with 1 being not confident and 10 being completely confident.
Measured: up to 24 weeks
Time of repair
Time taken for repair of fourth degree laceration
Measured: up to 24 weeks
Ease of use of model
Ease of use of the model as reported by participants. This is based on the participant's response to a 10 point Likert scale with 1 being not easy and 10 being the easiest.
Measured: up to 24 weeks
Satisfaction
Overall satisfaction of each model as reported by participants. This is based on the participant's response to a 10 point Likert scale with 1 being not satisfied and 10 being completely satisfied.
Measured: up to 24 weeks
Model realism
Model realism as reported by participants. This is based on the participant's response to a 10 point Likert scale with 1 being not realistic and 10 being the most realistic.
Measured: up to 24 weeks
Factors associated with higher knowledge scores
Factors associated with higher knowledge scores (e.g. PGY level, number of prior repairs, prior didactics). The written test is the same as the one used by Patel et al to evaluate residents' knowledge about fourth-degree laceration repair. The questions are based on Williams's obstetric chapter on episiotomy repair. The test has a minimum score of 0 and maximum score of 17 with a higher score indicating better performance.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start14 Nov 2017
- Primary completion29 Mar 2018
- Study completion29 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fourth Degree Perineal Laceration Involving Anal MucosaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Malek, University of Alabama at Birmingham
- Investigators
- Joseph Malek, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341351
- Sponsor's protocol ID
- IRB-300000074
- Status last verified
- Apr 2018
- First submitted
- 26 Oct 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Siddiqui NY, Stepp KJ, Lasch SJ, Mangel JM, Wu JM. Objective structured assessment of technical skills for repair of fourth-degree perineal lacerations. Am J Obstet Gynecol. 2008 Dec;199(6):676.e1-6. doi: 10.1016/j.ajog.2008.07.054.
PubMed 19084100Patel M, LaSala C, Tulikangas P, O'Sullivan DM, Steinberg AC. Use of a beef tongue model and instructional video for teaching residents fourth-degree laceration repair. Int Urogynecol J. 2010 Mar;21(3):353-8. doi: 10.1007/s00192-009-1042-3.
PubMed 19924368Illston JD, Ballard AC, Ellington DR, Richter HE. Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation. Obstet Gynecol. 2017 Mar;129(3):491-496. doi: 10.1097/AOG.0000000000001908.
PubMed 28178060
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Modified Beef Tongue Model for Teaching Repair of Obstetrical
- ClinicalTrials.gov ID
- NCT03341351
- Acronym / sponsor ID
- IRB-300000074
- Conditions
- Fourth Degree Perineal Laceration Involving Anal Mucosa, Obstetric; Injury, Obstetric Labor Complications
- Keywords
- Fourth-degree laceration, Beef tongue model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 29 Mar 2018 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study evaluating the use of the modified beef tongue model for teaching repair of obstetrical fourth-degree laceration to residents. Participants will be randomized to either an instructional video using the modified beef tongue model or to an instructional workshop using the modified beef tongue model. Primary outcome will be measured as change in technical skills score as measured by change from baseline on a validated objective structured assessment of technical skills (OSTATS) for repair of fourth-degree laceration.
Detailed description
Institutional Review Board approval has been obtained and written informed consent will be obtained prior to initiation of the study. All obstetrics and gynecology residents at the University of Alabama will be eligible for the study.
Eligible residents who desire will be enrolled and consented for the trial. Participants will then complete a short pre-intervention knowledge assessment written test and be asked to rate their confidence level in completing a fourth-degree repair based on a Likert scale. The written test is the same as the one used by Patel et al to evaluate residents' knowledge about fourth-degree laceration repair. The questions are based on Williams's obstetric chapter on episiotomy repair and showed construct validity given a significant difference in scores between postgraduate year (PGY)-1 and PGY-4 residents. Participants will also complete a baseline objective structured assessment of technical skills (OSATS) assessment for repair of fourth-degree obstetric laceration on a commercial anatomical replica, the Sultan Anal Sphincter Trainer (Limbs \& Things Inc, Savannah, Georgia). This model comes with a replaceable perineal pad that allows approximately 24 repairs before replacement is necessary. The validated OSATS used will be the assessment described by Siddiqui et al and validated on a surgical model. The repair will be videotaped and then distributed to evaluators who will use the 20 item task specific checklist described by Siddiqui et al. The time taken for the repair will be recorded.
Demographic and baseline data will be collected on the participants including PGY level, number of fourth-degree lacerations performed, whether they have read a textbook regarding fourth-degree laceration repair, whether they have read a journal article regarding fourth-degree laceration repair, whether they have attended a didactic session in pelvic anatomy, and whether they have attended a didactic session on fourth-degree laceration repair.
Participants will then be randomized into two groups. Randomization will be performed using a computer-generated block design so that each group has a balanced number of residents in each postgraduate year training level. One group will be randomized to the modified beef tongue video and one will be randomized to the modified beef tongue instructional workshop. The modified beef tongue video group will be given an instructional video created using the modified beef tongue model to show anatomy and proper repair of the laceration. The group randomized to the modified beef tongue instructional workshop will undergo an interactive workshop using the modified beef tongue model to show anatomy and proper repair of the laceration.
The modified beef tongue for the video and workshop will be prepared according to the model previously described in the literature. The modified model includes beef tripe (small intestine) used for anal mucosa and chicken leg muscles for anal sphincter muscle analogs. The tripe is tunneled through the body of the trimmed beef tongue and sutured like an ostomy to simulate the anal canal. The tongue is incised toward the tripe "anal canal." Chicken leg muscles are tunneled from the incision out to the cut edges of the beef tongue to create anal sphincter muscle analogs.
Following the didactic intervention, participants from each group will be given the written knowledge assessment test again and the objective structured assessment of technical skills (OSATS) for repair of fourth-degree laceration on the commercial anatomical replica again. The time taken for the repair will be recorded. Residents will also be asked to evaluate model realism, ease of use, and satisfaction using a Likert scale. The residents will be asked to assess their confidence again using a Likert scale.
The participants will then be crossed over and those who were initially randomized to the video group will then undergo the instructional workshop and the ones initially in the workshop group will be given the instructional video. Participants will then be asked to rate their overall preference between models on a scale of 1 to 10 with 1 being the video and 10 being the instructional workshop. They will also complete the written knowledge test again.
The results of this trial may help to inform to a cost- and time-efficient manner of instruction on the repair of 3rd and 4th degree lacerations. A weakness is that it is unclear whether this will translate to effectiveness at the time of an actual third- and fourth-degree repair.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instructional video | Active comparator | Other: Instructional videoThe modified beef tongue video group will be given an instructional video created using the modified beef tongue model to show anatomy and proper repair of the laceration. |
| Instructional workshop | Active comparator | Other: Instructional workshopThe group randomized to the modified beef tongue instructional workshop will undergo an interactive workshop using the modified beef tongue model to show anatomy and proper repair of the laceration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Residents currently in training program at University of Alabama at Birmingham
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Instructional videoInstructional video using the modified beef tongue model | Other | Instructional video |
| Instructional workshopInstructional workshop using the modified beef tongue model. | Other | Instructional workshop |
Primary outcome
Technical skills score
Time frame: up to 24 weeks
The primary outcome will be change in technical skills score measured as change from baseline in a validated objective structured assessment of technical skills (OSATS) for repair of fourth degree obstetric laceration. This OSATS was described by Siddiqui et al and is based on a task-specific checklist for fourth-degree lacerations and has a maximum score of 20 and minimum score of 0. The higher the score the better the performance.
8 secondary outcomes
Participant preference
Time frame: up to 24 weeks
Knowledge assessment
Time frame: up to 24 weeks
Participant confidence
Time frame: up to 24 weeks
Time of repair
Time frame: up to 24 weeks
Ease of use of model
Time frame: up to 24 weeks
Satisfaction
Time frame: up to 24 weeks
Model realism
Time frame: up to 24 weeks
Factors associated with higher knowledge scores
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 19084100Siddiqui NY, Stepp KJ, Lasch SJ, Mangel JM, Wu JM. Objective structured assessment of technical skills for repair of fourth-degree perineal lacerations. Am J Obstet Gynecol. 2008 Dec;199(6):676.e1-6. doi: 10.1016/j.ajog.2008.07.054.
- Background: PubMed 19924368Patel M, LaSala C, Tulikangas P, O'Sullivan DM, Steinberg AC. Use of a beef tongue model and instructional video for teaching residents fourth-degree laceration repair. Int Urogynecol J. 2010 Mar;21(3):353-8. doi: 10.1007/s00192-009-1042-3.
- Background: PubMed 28178060Illston JD, Ballard AC, Ellington DR, Richter HE. Modified Beef Tongue Model for Fourth-Degree Laceration Repair Simulation. Obstet Gynecol. 2017 Mar;129(3):491-496. doi: 10.1097/AOG.0000000000001908.
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.
Joseph Malek, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructional video and Instructional workshop in people with Fourth Degree Perineal Laceration Involving Anal Mucosa and Obstetric; Injury, run by University of Alabama at Birmingham at 1 site in United States.
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 1 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Technical skills score (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03341351, which also lists 3 linked publications.
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 18 Apr 2018.