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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT03341351
Study groupRoleWhat they receive
Instructional videoActive comparatorThe 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 workshopActive comparatorThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. Time of repair

    Time taken for repair of fourth degree laceration

    Measured: up to 24 weeks

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted14 Nov 2017
  2. Study start14 Nov 2017
  3. Primary completion29 Mar 2018
  4. Study completion29 Mar 2018

Resources

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)
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 19084100
  • Patel 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 19924368
  • Illston 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

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.

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