Use of the Modified Beef Tongue Model for Teaching Repair of Obstetrical
Phase: NA
Conditions: Fourth Degree Perineal Laceration Involving Anal Mucosa, Obstetric; Injury, Obstetric Labor Complications
Sponsor: University of Alabama at Birmingham

 
 
Cover Page 
Title: Use of the Modified Beef Tongue Model for Teaching Repair of Obstetrical Fourth-Degree 
Laceration to Residents 
Approved by the Human Subjects IRB at UAB 
Date of Document: 11/8/2017 
 
This document contains the Protocol and also the Statistical Analysis Plan which is on page 9

Research Protocol 
 
Use of the Modified Beef Tongue Model for Teaching Repair of Obstetrical Fourth-Degree 
Laceration to Residents 
 
 
Joseph Malek, MD1 
Jana Illston, MD1 
Julie Covarrubias, PhD2 
Isuzu Meyer, MD1 
Alicia Ballard, MD1 
Holly E Richter, MD1 
 
 
 
1.  Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics 
and Gynecology, University of Alabama Birmingham, Birmingham, AL 
2. Office of Education, Department of Obstetrics and Gynecology, University of Alabama 
Birmingham, Birmingham, AL 
 
 

Corresponding Author:  
Joseph Malek, MD  
1700 6th Avenue South, Suite 10382 
Birmingham, AL 35233 
Phone: (205) 996-5466 
Fax: (205) 975-8893 
Email: jmalek@uabmc.edu 
 
FINANCIAL DISCLAIMER/CONFLICT OF INTEREST: NONE 
JM Malek: Protocol/project development, data collection, manuscript writing/editing 
 
 

Background/Rationale: 
 
Obstetric lacerations are a common complication of vaginal deliveries affecting three 
fourths of all vaginal births [1] with third and fourth degree lacerations, which increase the risk 
of fecal incontinence, complicating up to 11% of vaginal deliveries [2].  Up to 50% of women 
experience some degree of fecal incontinence after anal sphincter repair [3].  Anal sphincter gaps 
detected by ultrasound are prevalent in postpartum primiparous women with a history of 
sphincter tear and are associated with fecal incontinence severity [4].   
 
In academic centers, lacerations are often repaired by residents.  Approximately 60% of 
obstetrics/gynecology (ob/gyn) residents in residency programs in the United States admitted to 
not having any didactic teaching on episiotomy repair and no formal teaching on pelvic floor 
anatomy and when engaged in the repair, were supervised only a third of the time [5]. It has been 
shown that with the rise in cesarean sections and decline in operative vaginal deliveries, the 
prevalence of third- and fourth-degree lacerations has been decreasing in recent years and this 
has resulted in limited exposure to repairs and lack of residents’ confidence to properly repair 
advanced perineal lacerations [6,7].  One study evaluating 40 ob/gyn residents at 13 different 
residency programs showed an overall pass rate of only 42.5% with many residents missing 
critical steps of the repair [7].   
 
Surgical models have been increasing in popularity and have been shown to improve 
surgical skills and knowledge base [3, 6].  It has further been shown that anatomical models and 
hands-on workshops on how to repair fourth-degree lacerations can improve knowledge and 
surgical technique [3].  Beef tongue models have been used in the education and assessment of 
surgical skills for fourth-degree laceration repair [3,6,8].  One study compared a beef tongue 

model to sponge model showing all participants preferred the beef tongue model [6].  Siddiqui et 
al used a beef tongue model to validate a task specific Objective Structured Assessment of 
Technical Skills (OSATS) for the repair of fourth-degree obstetric lacerations [9].  We recently 
demonstrated a modified beef tongue model that used beef tripe (small intestine) for the anal 
mucosa and chicken leg segments for the anal sphincter muscle analogs to create a realistic 
model [10].   
 
Given the decreasing number of third- and fourth degree lacerations and poor resident 
confidence and performance demonstrated in these repairs, better and more widely used teaching 
methods are necessary.  The modified beef tongue model serves as a realistic tool to teach and 
assess fourth-degree laceration anatomy and repair.  While workshops have been shown to 
improve knowledge and technical skills [3], these require significant time, expense, and 
organization.  Instructional videos can be used to serve the same purpose without these 
limitations and thus could lead to wider use as a didactic intervention for fourth-degree repair.  
Instructional videos have been evaluated for fourth-degree repair in a limited manner.  One study 
showed an improvement in knowledge after an instructional video but only in residents with no 
prior experience in repair of lacerations [8] and we could not find any that assess change in 
outcomes on technical surgical skills.   
 
We believe that an instructional video that utilizes the modified beef tongue model is a 
valuable educational tool to increase resident knowledge, confidence, and surgical ability to 
properly repair a fourth degree laceration.  The aim of this study is to compare technical skills 
outcomes with an instructional video using the modified beef tongue model to a modified beef 
tongue hands-on educational workshop.  Our hypothesis is that participants will have similar 

improvements in their technical skills for repair of fourth-degree laceration as evaluated by an 
objective structured assessment of technical skills (OSATS). 
Null hypothesis: Participants undergoing the modified beef tongue instructional video will have 
worse outcomes on an objective structured assessment of technical skills (OSATS) for repair of 
fourth degree obstetric laceration than those undergoing a modified beef tongue educational 
workshop.   
Significance 
There are no studies evaluating the use of an instructional video for fourth-degree laceration 
repair to assess change in outcomes on technical skills.   
Study Design 
Inclusion Criteria 
PGY1-4 residents in an obstetrics and gynecology training program 
Exclusion Criteria 
None 
Intervention 
Instructional video using the modified beef tongue model or instructional workshop using the 
modified beef tongue model. 
Primary outcome 

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. 
Secondary outcomes 
1. Participant preference of model between instructional video and instructional workshop 
2. Knowledge assessed by written test performed pre- and post-intervention 
3. Participant’s confidence in fourth-degree laceration repair as measured by change in 
confidence score from pre- to post-intervention.   
4. Time taken for repair of fourth degree laceration 
5. Ease of use of the model as reported by participants 
6. Overall satisfaction of the model 
7. Model realism 
8. Factors associated with higher knowledge scores (e.g. PGY level, number of prior 
repairs, prior didactics) 
Protocol in detail 
 
Institutional Review Board approval 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 [8].  The questions are based on Williams’s obstetric chapter on 
episiotomy repair [11] and showed construct validity given a significant difference in scores 
between postgraduate year (PGY)-1 and PGY-4 residents [8].  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 [9].  The repair will be videotaped and then distributed to evaluators who will use the 20 
item task specific checklist described by Siddiqui et al [9].  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 [11].  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. 
Statistical Analysis Plan 
 
Given the fixed set of residents, a post hoc power analysis will be performed.  
Categorical variables will be analyzed using chi-squared or Fisher exact tests and continuous 
variables will be analyzed using student t-tests.  The mean scores of knowledge assessment and 
from the Objective Structured Assessment of Technical Skills (OSATS) as well as the change in 
scores pre- and post-intervention will be compared using Student t-tests.  Differences in 
improvement scores between the two groups will be further examined using linear regression 
models, adjusting for baseline score and year of training.  Differences in the score improvement 
between the two study groups and for each resident year will be analyzed using Wilcoxon rank 
test.   
 
 

References 
1. Vale de Castro Monteiro M, Pereira GM, Aguiar RA, Azevedo RL, Correia-Junior MD, 
Reis ZS. Risk factors for severe obstetric perineal lacerations. Int Urogynecol J 
2016;27:61–7. 
2. Dudding TC, Vaizey CJ, Kamm MA. Obstetric anal sphincter injury: incidence, risk 
factors, and management. Ann Surg 2008;247:224–37. 
3. Siddighi S, Kleeman SD, Baggish MS, Rooney CM, Pauls RN, Karram MM. Effects of 
an educational workshop on performance of fourth-degree perineal laceration repair. 
Obstet Gynecol 2007;109:289–94. 
4. Richter HE, Fielding JR, Bradley CS, et al.  Endoanal Ultrasound Findings and Fecal 
Incontinence Symptoms in Women With and Without Recognized Anal Sphincter Tears.  
Obstet Gynecol 2006;108:1394-1401.   
5. McLennan MT, Melick CF, Clancy SL, Artal R. Episiotomy and perineal repair: an 
evaluation of resident education and experience. J Reprod Med 2002;47:1025–30. 
6. Dancz CE, Sun V, Moon HB, Chen JH, Özel B. Comparison of 2 simulation models for 
teaching obstetric anal sphincter repair. Simul Healthc 2014;9:325–30. 
7. Uppal S, Harmanli O, Rowland J, Hernandez E, Dandolu V. Resident competency in 
obstetric anal sphincter laceration repair. Obstet Gynecol 2010;115:305–9. 
8. 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; 21:353–8. 
9. Siddiqui NY, Stepp KJ, Lasch SJ, et al. Objective structured assessment of technical 
skills for repair of fourth-degree perineal lacerations. Am J Obstet Gynecol 
2008;199:676.e1Y676.e6. 
10. Illston JD, Ballard AC, Ellington DR, Richter HE.  Modified beef tongue model for 
fourth-degree laceration repair simulation.  Obstet Gynecol 2017;129:491-96. 
11. Cunningham FG, Leveno KJ, Bloom SL, Hauth JC, Gilstrap LC III, Wenstrom KD 
(2005) Normal labor and delivery. In: Seils A, Edmonson KG, Davis K (eds) Williams 
obstetrics, 22nd edn. McGraw-Hill, New York, pp 435–438.