Randomized Controlled Trial Comparing Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair
Phase: NA
Conditions: Inguinal Hernia
Sponsor: The Cleveland Clinic

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Registry Based, Randomized Controlled Trial Comparing Telescopic dissection vs. Balloon 
Dissection for Laparoscopic Totally Extraperitoneal Inguinal Hernia Repair (TEP)  
P.I.: Michael J. Rosen, MD FACS 
Director, Cleveland Clinic Comprehensive Hernia Center 
 
NCT: 03276871 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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INTRODUCTION 
  
Minimally invasive approaches have been successfully incorporated into the surgical 
armamentarium of inguinal hernia repair, with proven benefits for decreased postoperative pain 
and earlier return to work [1]. Laparoscopic inguinal hernia repair is more commonly performed 
through the transabdominal preperitoneal (TAPP) approach or the totally extraperitoneal (TEP) 
approach. The TEP approach has been proven to have equivalent recurrence rates, decreased 
postoperative pain, earlier ambulation and return to work when compared to the open, tension-
free repairs. [1,2] Additionally, when compared to TAPP, the TEP approach has also been 
associated with decreased postoperative pain, shorter operative times and equivalent rates of 
postoperative complications and hernia recurrence [3].  
A key step in the TEP procedure is the creation of the extraperitoneal space, which can be 
performed using either telescopic dissection or with a balloon dissector.[1-4] Telescopic dissection 
is the creation of the extraperitoneal space with blunt dissection performed with the laparoscopic 
probe. Telescopic dissection was initially described in the original paper describing the TEP 
procedure, in 1992 by Ferzli et al. [5]. To date, telescopic dissection is still used in many centers 
around the globe [4]. In order to facilitate the creation of the initial working space, disposable 
dissection balloons have been developed and are commercially available. Balloon dissection is 
now the most commonly used method for creation of the extraperitoneal space for TEP procedure 
in the United States [4]. A randomized, prospective multicenter study conducted between 1994 
and 1997 and published in 2001 by Bringham and colleagues [6] has compared operative times, 
conversion rates, postoperative morbidity and time to return to work between patients in which 
the TEP procedure was performed with or without the balloon dissector. In this study, the use of 

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the balloon was associated with lower conversion rates and statistically, but perhaps not clinically, 
significantly shorter operative times (9 minutes difference). No difference was seen in 
postoperative morbidity, recurrence rates or time to return to work between the groups. Of note, 
the surgeons performing these procedures were still at an early point of their learning curve for 
the TEP procedure, which might have influenced the results, especially for the group without the 
balloon.  
Low-cost alternatives have been proposed to substitute the commercially available balloon 
dissector, especially in developing countries where the access to the balloon dissector is restricted.  
Despite the fact that the TEP procedure has become more popular in the last 15 years, with 
surgeons being each time more proficient in this operation, there is a paucity of data comparing 
cost and surgical outcomes among telescopic and balloon dissection.  
Furthermore, according to current consensus,  the use of a balloon dissector is especially 
recommended during the learning period when surgeons are still unfamiliar with the 
preperitoneal anatomy.[5] Especially for expert surgeons, delineation of the inguinal area  and 
dissection in the creation of extraperitoneal space can be performed as safe and efficient with 
telescopic dissection.[3,4] 
The TEP procedure for inguinal hernia repair is performed on a regular basis by numerous 
surgeons at our institution, both with and without the use of a balloon dissector, according to 
each surgeon’s expertise and preference. At our institution, the commercially available disposable 
balloon dissector (SpaceMaker™, Medtronic, Minneapolis, MN) costs around US$ 600, increasing 
the direct cost of the procedure. Therefore, the regular use of the balloon dissector is associated 
with a significant expenditure to the institution. Nevertheless, if the use of the balloon dissector 

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confers a significant decrease in operative times reflecting a decrease in the total costs of the 
procedure, its use would still be economically advantageous.  
One of the co-investigators (Dr. Kalman Bencsath) listed in this protocol, has been 
performing his TEP procedures consistently using telescopic dissection, with equivalent results and 
safety profiles when compared to balloon dissection.  Our institution has in its staff, three expert 
surgeons, with a robust experience in the TEP procedure, performed either with and without the 
balloon dissector. To help determine if the use of the balloon dissector is associated with a 
significant decrease in operative times when compared to telescopic dissection, we aim to 
conduct a randomized controlled trial using the Americas Hernia Society Quality Collaborative 
(AHSQC)  registry. The AHSQC is a nationwide registry designed to improve the value of hernia 
care using real-time continuous quality improvement principles[7].  Data pertaining to baseline 
and intraoperative variables, short and long term outcomes are collected prospectively for quality 
improvement purposes. The information collected in the AHSQC offers a natural repository of 
information that can be used for research, in addition to its quality improvement purpose.   
We hypothesize that at our institution, during TEP repairs, telescopic dissection will be 
associated with a 15-minute increase in total  operative times for a unilateral inguinal hernia, 
when compared to the balloon dissection using the SpaceMaker™ balloon. 
 
Specific Aim #1:  To determine if the use of a balloon dissector by an experienced 
surgeon is associated with a significant decrease in total operative time compared to 
telescopic dissection for the creation of the extraperitoneal space during 
laparoscopic TEP inguinal hernia repair 

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Specific Aim #2: To perform a cost analysis for direct and total hospital costs among 
patients who have undergone laparoscopic TEP inguinal hernia repair performed 
either with telescopic dissection or balloon dissection  
Specific Aim #3:  To determine if there is a difference in postoperative pain scores at 
1 day, 7 days and 30 days postoperatively between patients who have undergone 
laparoscopic TEP inguinal hernia repair performed either with telescopic dissection 
or balloon dissection.   
Specific Aim #4: To determine if there is a difference in the rate of intraoperative 
complications and 30-day wound events between patients who have undergone 
laparoscopic TEP inguinal hernia repair with and without use of a balloon dissector  
Specific Aim #5: To determine if 1-year hernia recurrence rates differ between 
patients who have undergone laparoscopic TEP inguinal hernia repair performed 
either with telescopic dissection or balloon dissection.   
 
 
STUDY DESIGN 
This trial will follow the same methodology of data collection employed in previous 
randomized controlled trials (RCTs) performed by the Cleveland Clinic Hernia Center, and the 
AHSQC registry will serve as the main platform for data collection. Registry-based trials use data 
available in a preexisting database to increase the efficiency of performing RCTs, decreasing the 
high cost and logistical challenges associated with operationalizing this type of research.  
This will be a single institution study, performed at the Cleveland Clinic Foundation in 
Cleveland, Ohio, with a total of 3 participating staff surgeons (Dr. Diya Aladeen, Dr. Kalman 

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Bencsath, and Dr. Steven Rosenblatt). Enrollment and surgeries are anticipated to occur at 
Cleveland Clinic Hernia Center located at Main Campus, Fairview Hospital, and Hillcrest Hospital. 
Additionally, enrollments and surgeries will occur in Strongsville and Beachwood Family Health 
and Surgery Centers.  
Specific patient inclusion criteria include all patients aged 18 years or older presenting for 
an elective unilateral inguinal hernia repair, who are able to tolerate general anesthesia and are 
considered eligible to have a hernia repair through a laparoscopic TEP approach. Patients 
presenting with  primary or recurrent inguinal hernias will be considered eligible to be enrolled in 
this study.  
Exclusion criteria include patients with bilateral inguinal hernias,  recurrent hernias that 
have a prior preperitoneal mesh (which can include plug and patch, PHS, and laparoscopic inguinal 
hernia repairs), patients who cannot tolerate general anesthesia, patients who are not willing to 
undergo a mesh-based repair, and patients who are not able to understand and sign an written 
consent form.  The intervention will be telescopic dissection alone for the creation of the 
extraperitoneal space. The control group will undergo preperitoneal dissection with the use of the 
SpaceMaker™ balloon dissector (Medtronic, Minneapolis, MN) for the creation of the 
extraperitoneal space. Patients will be randomized to balloon dissector group versus telescopic 
dissection alone at anesthesia induction. No other intraoperative or postoperative differences will 
occur between the two groups. 
To confirm that the procedure technique  will be standardized and performed consistently 
in the same manner among the three participating surgeons, one of the Co-Investigators (Dr. 
Kalman Bencsath) will record one of his procedures using telescopic dissection. This will be an 
educational video, to serve as a reference,and used to instruct and standardize the technique 

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among the other two participating surgeons (Dr. Diya Aladeen and Dr. Steven Rosenblatt). Dr. 
Bencsath will also be a source of reference and support for technical details regarding the 
performance of preperitoneal dissection using telescopic dissection. Dr. Bencsath has determined 
that three telescopic balloon dissection cases are required to overcome the learning curve in 
experienced surgeons hands, and thus all surgeons will document three cases prior to induction of 
the trial.  Baseline information, operative details including the exposure variable (type of 
extraperitoneal space creation method), and outcomes of interest (operative time, 30-day wound 
morbidity, complications, and hernia recurrence) are already captured within the AHSQC 
database, allowing for follow-up, and data capture with decreased effort outside that of routine 
care. The only variables not captured in the AHSQC will be the postoperative pain scores and the 
costs related to the operation. This information will be captured and stored in RedCAP®. 
Baseline patient demographics will be obtained at initial patient recruitment, and baseline 
AHSQC questionnaires will be completed following patient recruitment for baseline comparison. 
Exact total operative times will be abstracted from electronic medical records on EPIC and 
uploaded into REDCap. All operative details are already routinely collected and stored in the 
AHSQC database. Pain intensity at baseline, 1 day, 7 days and 30 days postoperatively will be 
assessed using the Numeric Pain Rating Scale (NRS-11). The NRS-11 is a simple, one-dimensional 
test, in which individuals are asked to score pain on a 0 (no pain) to 10 (worst pain imaginable) 
scale.[8].  Patient follow-up visits will occur in person at  4 weeks (+ 2 weeks) and 12 months (+ 3 
months) postoperatively. In case patients are unable to attend their regular follow-ups, a 
telephone interview will also be performed. At baseline and at 30 days postoperatively, these 
assessments will be performed in person. Since most of the laparoscopic TEP procedures are 
performed on an outpatient basis, and patients are discharged on the same day of operation, 

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assessments at 1 day and 7 days postoperatively will be performed via telephone contact and this 
information will be uploaded into REDCap. Patient-reported quality of life will also be assessed at 
baseline and at 30 days using the EuraHS Quality of life score (European Registry of Abdominal 
Wall Hernias)[9], which is collected for all patients entered into the AHSQC as part of the AHSQC 
Inguinal Hernia Postoperative Assessment.  Patients will be required to complete these forms at 
each clinic visit, or via telephone contact, as this is standard procedure for all patients entered into 
the AHSQC. Hernia recurrence will be assessed at 30-days and at one year postoperatively, using 
the Ventral Hernia Recurrence Inventory (VHRI) survey and by physical examination.The VHRI is a 
validated questionnaire that can be performed either in person or via email or phone 
correspondence and assesses patient perception of hernia recurrence symptoms.[10] At the time 
of the one-month and one-year follow-up clinic visits, a routine physical examination will be 
performed on all patients. At the completion of the study protocol, patients will be informed of 
their intervention arm.  
A cost analysis will be performed. The direct cost and total hospital cost will be provided by 
the administration of the Digestive Disease and Surgery Institute.  
 
OUTCOMES TO BE INVESTIGATED 
 
Each outcome to be investigated is based on the specific aims of the study and are listed 
below: 
 Specific Aim #1: To determine if the use of a balloon dissector, in experienced 
hands, is associated with decreased total operative times compared to the 

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telescopic dissection, for the creation of the extraperitoneal space during 
laparoscopic TEP inguinal hernia repair.  
This will be assessed comparing mean total operative times between groups.  
 Specific Aim #2:  Perform a cost comparison analysis accounting for direct 
costs and total hospital costs among patients who have undergone 
laparoscopic TEP inguinal hernia repair with the use of a balloon dissector or 
telescopic dissection for the creation of the extraperitoneal space.  
This analysis will ultimately determine if the hypothetical decrease in 
operative times  related to the use of SpaceMaker™ balloon dissector 
(Medtronic, Minneapolis, MN) might overcome the direct cost of this device, 
for the laparoscopic TEP inguinal hernia repair.  
 Specific Aim #3: To determine if there is a difference in postoperative pain 
scores at, 1 day, 7 days and 30 days postoperatively between patients who 
have undergone laparoscopic TEP inguinal hernia repair with the use of a 
balloon dissector or telescopic dissection for the creation of the 
extraperitoneal space.  
This will be accomplished by comparing mean postoperative pain scores 
between the groups at each defined time point.  
 Specific Aim #4: To determine if there is a difference in the rate of 30-day 
wound morbidity and intraoperative complications among patients who have 
undergone laparoscopic TEP inguinal hernia repair with the use of a balloon 
dissector or telescopic dissection for the creation of the extraperitoneal space 

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This will be accomplished comparing the rates of 30-day wound events. 
Wound events are defined as surgical site infections (SSI), surgical site 
occurrences (SSO) and surgical site occurrences requiring procedural 
intervention (SSOPI).  Intraoperative complications are defined as hemorrhage 
requiring transfusion, preperitoneal access injury, bowel injury, bladder injury, 
liver injury, gastric injury, major vascular injury requiring operative 
intervention, spermatic cord injury, and testicular injury. This information is 
already captured in the AHSQC and is also reported in electronic medical 
records.        
SSIs will be reported and classified according to the Centers for Disease Control and 
Prevention (CDC) classification [11], as superficial, deep incisional and organ-space.  
SSO include any SSI as well as wound cellulitis, non-healing incisional wound, fascial disruption, 
skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous or purulent drainage, stitch 
abscess, seroma, hematoma, infected or exposed mesh, or development of an enterocutaneous 
fistula.[12,13] SSOPI is defined as any SSO that requires wound opening, wound debridement, 
suture excision, percutaneous drainage, or partial or complete mesh removal.[12,13].   
 Specific Aim #5: : To determine if there is a difference in clinical hernia 
recurrence at one year postoperatively, among patients who have undergone 
laparoscopic TEP inguinal hernia repair with the use of a balloon dissector or 
telescopic dissection for the creation of the extraperitoneal space . 
This will be assessed through physical examination performed by a surgeon at the 1-year 
follow-up clinical encounter . Additionally, as it is customary for all patients in the AHSQC, subjects 
will answer the Ventral Hernia Recurrence Inventory Survey [10], which is part of AHSQC Inguinal 

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Hernia Postoperative Inguinal Hernia Assessment would make sure this can be performed by 
phone call too, so we limit lost to follow-up.  
SURGICAL PROCEDURE 
Patient preparation and initial operative steps, common for both groups  
Patients will be operated in supine position, in a slight Trendelenburg position (15º 
degrees), with arms tucked along the body. The procedure will be performed under general 
anesthesia. Antibiotic prophylaxis will be performed according to institutional protocol. Patients 
will receive a single dose of 2000mg of Cefazolin, within one hour of the incision. In case patients 
are allergic to this drug, a single dose of 600mg of Clindamycin will be administered. 
Pharmacological prophylaxis of venous thromboembolic events is usually not necessary for usual 
laparoscopic inguinal hernia repair. Although, if deemed necessary, this will be performed per SCIP 
protocol and will not be considered a protocol deviation. Foley catheterization will be performed 
preoperatively in all patients in order to the bladder be decompressed during the operation. Skin 
preparation and hair removal will be performed per SCIP protocol. All necessary materials, 
including the SpaceMakerTM balloon, will be available in the operative room before the start of the 
procedure. 
After induction of anesthesia, randomization will occur. Randomization will be performed 
according to a computer-generated block randomization scheme, which will take place in RedCAP. 
The operative room nurse will call a designated phone number where will be able to speak to the 
research coordinator who will perform the randomization in RedCAP and will inform in which 
group the patient has been assigned. 

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The procedure begins with a juxta-umbilical incision. Subcutaneous tissue is dissected to 
expose the rectus sheath. A small transverse incision in the fascia is made, where the rectus 
muscles fibers can be identified. Muscle fibers are retracted laterally exposing the posterior rectus 
sheath.  
 For the balloon dissector group 
A blunt tip 10mm disposable balloon trocar is placed in the preperitoneal space. The balloon 
dissector is inserted through this port, into the direction of the pubic bone. After the proper 
position is confirmed with direct visualization, the balloon is inflated under direct visualization. 
After dissection is completed, the balloon is deflated and removed from the preperitoneal space. 
Insufflation of CO2 is performed with a 15mmHg pressure through the trocar.  
 
 For the telescopic dissection group 
After the rectus muscle fibers are retracted laterally, a gentle finger dissection is performed in the 
retrorectus/preperitoneal space in order to create space for insertion of a 10mm, blunt tip, 
balloon trocar. Insufflation of CO2 is performed with a 15mmHg pressure through the trocar. A 30 
degrees laparoscopic scope is inserted, and blunt dissection of the preperitoneal space is 
performed with the probe, under direct visualization, in the direction of the pubic bone, creating 
space on the midline.  
Common operative steps for both groups  

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After the initial workspace is created, two 5mm disposable trocars are placed in the midline. One 
5mm trocar is placed 3 fingerbreadths above the pubic bone. The other is placed between the 
initial and the suprapubic trocar. Complete dissection of the preperitoneal space is performed.  
This includes medial dissection into the space of Retzius and lateral dissection into the lateral 
space of Bogros.  Proper identification of the inferior epigastric vessels, cord structures, vas 
deferens, iliac vessels, pubic bone and Cooper’s ligament, is mandatory. Anatomic landmarks 
known as the ”Triangle of Doom” and ”Triangle of Pain” have to be identified. Correct dissection 
and exposure of the entire myopectineal orifice are mandatory. For indirect inguinal hernias, the 
hernia sac is dissected free from the cord structures and reduced. Preperitoneal lipomas are 
reduced and resected. The ”pseudosac” of direct defects is also dissected and reduced. In case a 
femoral or obturator defect is identified, the contents are dissected and reduced with gentle 
traction. When complete dissection is achieved, the mesh repair can be performed. Any tears in 
the peritoneum should be repaired. This can be accomplished by suture, stapling or through 
endoloops, according to surgeon’s preference and expertise.  
Mesh selection will be at the discretion of the co-investigator surgeon. A standard piece of 
polypropylene mesh will be utilized, and the size and type will be recorded.  A minimum of 10x15 
cm mesh will be used.    Mesh is rolled and placed under direct visualization into the preperitoneal 
space through the 10mm trocar. Mesh in unrolled and placed in position, adequately covering the 
entire myopectineal orifice, with sufficient overlap. Mesh fixation is performed according to the 
surgeon's discretion and type and number of tack fixation devices will be recorded. Hemostasis is 
reviewed, and CO2 is desuflatted from the preperitoneal space under direct visualization, 
confirming proper mesh position. Ports are removed, and the anterior rectus sheath incision is 

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closed with absorbable sutures. Subcutaneous tissue and skin are closed according to surgeon’s 
preference.  
ANTICIPATED TIME FRAME 
 
Estimated patient accrual time is one year with data collection to occur over one 
year from the last enrolled patient. Data analysis and manuscript production will occur within six 
months of completion of data collection.  
PATIENT RISKS AND DISCOMFORTS 
 
As with any surgical procedure, there are some associated risks, and these risks will be 
discussed in a separate surgical consent form. The subjects may experience some pain, bleeding, 
and discomfort; however, this is with any surgical operation.  Common occurrences following 
hernia repair include seroma or hematoma around the hernia repair, inflammation, or infection. 
Patients will be made aware of the risk for conversion to a laparoscopic transabdominal 
preperitoneal (TAPP) approach or an open approach if considered necessary by the attending 
surgeon. Additionally, the risk of injuries to the bladder, iliac vessels, epigastric vessels, cord 
structures and vas deferens during preperitoneal space or hernia dissection  are always discussed 
prior to any inguinal hernia repair. The risk of postoperative chronic pain and hernia recurrence 
will be discussed in detail during the preoperative visit, as it is usual for every inguinal hernia 
repair. This will occur independently of patient participation in this study. 
PATIENT BENEFITS 
There are no direct benefits to subjects for participating in this study.  Subject 
participation will help to improve the general knowledge of minimally invasive hernia repair.  
COSTS TO THE SUBJECTS 

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There are no extra costs to the subjects associated with the research.  Procedures 
related to the preoperative evaluation and the hernia surgery are considered standard of care and 
will be the responsibility of the subject and the subject’s insurance company.   
ALTERNATIVES TO PARTICIPATION 
Patients are under no obligation to participate in this study.  A member of the 
research will discuss all available surgical options to the patients.  Declining to participate in this 
study will not impact any patient’s ability to receive care or to undergo ventral hernia repair at the 
Cleveland Clinic Foundation. 
PAYMENTS TO THE SUBJECTS 
Subjects will not receive payment for their participation or any activity related to this 
proposed study.  
PLAN FOR OBTAINING INFORMED CONSENT 
For each subject, written informed consent will be obtained prior to any protocol-
related activities. As part of this procedure, the principal investigator, surgeon co-investigator, or 
one of the approved study coordinators must explain orally and in writing the nature, duration, 
and purpose of the study in such a manner that the subject is aware of the potential risks, 
inconveniences, or adverse effects that may occur. The subjects will be informed that they may 
withdraw from the study at any time.  Subjects will receive all information that is required by 
federal regulations. 
After a potential study patient is identified, the investigator or the study coordinator 
listed in this protocol as a person who will obtain consent will be responsible for instituting the 

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informed consent process in a face-to-face manner. Before starting any study procedures, the 
investigator will discuss the proposed research study in detail with the potential subject during the 
office visit to discuss treatment options.  The subject will be allowed ample time to read and 
review the informed consent document, and ask questions.  The informed consent document will 
be reviewed with the subject in depth by the participating investigator or designated member of 
the research team to ensure that the potential participant has a good understanding of the study 
protocol, what is required of the study participants, the potential risks and benefits of study 
participation, and his or her rights as a study participant.  The investigators will be available by 
phone or office visit to answer any questions that the participant may have.  After consideration, 
the subject may return if necessary for another visit with the investigator to discuss the study, ask 
questions, and sign the informed consent document to participate in this study.  
After the subject has read and reviewed the informed consent document and has 
agreed to participate, he/she will be asked to sign and date the document. The study member 
obtaining consent will also sign and date the form, and documentation of the informed consent 
process will be included in the research file (i.e., the person who obtained consent, where and 
when consent was obtained, and who was present during the process). A copy of the consent form 
will be given to the subject for their records.  
 
PROVISIONS FOR SUBJECTS FROM VULNERABLE POPULATIONS 
                 The population to be studied includes adults 18 years of age or over, so children are 
therefore excluded.  Decisionally-impaired and cognitively-impaired persons will not be 
approached to participate in this study as we are seeking subjects who have the capacity to 

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understand and actively consent to the procedure independently.  Pregnant women will be 
excluded from participating in this study.  
 
                  Staff and employees at the participating institutions are considered a part of the 
vulnerable population.  Staff and employees may be eligible to participate in this study. Since 
subjects may or may not benefit from this study, we do not want to exclude this population.  If an 
employee is a potential candidate for this study, the subject will be informed during the consent 
process that his/her participation or refusal to participate will in no way influence grades, 
employment, or subsequent recommendations.  Every effort will be made to prevent coercion 
during this initial process and throughout study participation.  According to IRB policy, students 
and house staff cannot be asked to participate in research conducted while under the direct 
supervision of the investigator, so those subjects will not be enrolled.  
In those instances where potential participants cannot read the consent form 
because they do not speak English, we will work with the IRB to develop a language-appropriate 
consent form.  In addition, a qualified translator will be present to assist with obtaining the 
informed consent of the participant and throughout the duration of the patient’s participation in 
the study.   
In addition, in the unusual situation where a subject cannot read a consent form  due 
to illiteracy or blindness, a member of the research study staff will read and explain the consent 
form to the participant or to the participant’s legally authorized representative.  A witness, who 
will sign and date the consent form, must also be present during this oral presentation. 
 
 

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SUBJECT PRIVACY AND DATA CONFIDENTIALITY 
Anonymity and confidentiality of subjects participating in this study will be 
maintained. The only potential identifiers on any study documents submitted to the sponsor or 
designee will be subject study numbers, dates of birth, and dates of procedures.  Every effort will 
be made to maintain the confidentiality of documents that identify the subject by name (e.g., 
signed informed consent documents, clinic charts), except to the extent necessary to allow 
monitoring by the Office of Research Compliance at the Cleveland Clinic or other regulatory 
authorities.   
All information collected, such as name or medical record number, will be stored in 
the AHSQC database. Randomization will occur with the use of a customized Research Electronic 
Data Capture (REDCap®) database program. This is in a secure network/firewall protected 
electronic database to which only the investigator and the designated members of the study team 
will have access using an individual assigned login and password. Only approved study members 
listed on the IRB protocol will have access to the separately-stored master list. Only the Principal 
Investigator, Lead Research Coordinators, and Biostatisticians will be granted access to retrieve 
patient data for routine data quality assessments and data analyses. All electronic records 
pertaining to the clinical study will be password-protected and only approved study members 
listed on the IRB protocol will have password access. 
Any information about the subject will be stored in the AHSQC, a secure database 
that is used at our institution to track clinical outcomes in patients who undergo hernia repair. 
POWER CALCULATION 

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Sample size and power calculation were performed according to the primary 
outcome measure, which will be operative time.  All TEP laparoscopic inguinal hernia repairs 
performed in the last year (from June 2016 through June 2017) by the participating surgeons were 
identified. Operative times from 22 randomly chosen laparoscopic TEP repairs for  unilateral 
inguinal hernias using the balloon (control group), were abstracted. Mean operative time was 
56.31 minutes with a standard deviation of 14.47 minutes.  
Using a two-sample t-test allowing for an equal variance with equal sample sizes 
(1:1) group allocation of telescopic and balloon dissection, and assuming the hypothesis that the 
intervention group (telescopic dissection) will be associated with a 15-minute increase in total 
operative time when compared to the control group (balloon dissection), 15 patients per group 
will achieve a target power of 80% given an alpha of 0.05.  Assuming a 30% loss to follow-up at 1 
year, a total of 40 patients will be recruited for this study (20 patients in each group). 
STATISTICAL ANALYSIS 
 
Categorical variables will be examined using Pearson’s Chi-Square and all continuous 
variables will be examined using the nonparametric Wilcoxon signed rank test.  The categorical 
variables will be reported using proportions and continuous variables will be reported using the 
median and interquartile range. 
 
          Specific Aim 1: Total operative times between intervention arms will be compared 
using Kruskal-Wallis Test. 
Specific Aim 2: Univariate cost analysis will be performed through a Student's t-test 

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of logarithmically transformed mean values of direct and total hospital costs.  Net revenue earned 
will be determined by subtracting the cost of the balloon dissector (only in the balloon dissector 
arm) from the cost saved for less operative time.  
Specific Aim 3: Pain scores can be compared at each time-point using Kruskal-Wallis 
Test.  Differences in pain scores between intervention arms (baseline subtracted from pain at each 
time point) will also be compared using Wilcoxon rank-sum test. 
Specific Aim 4/5: 30-day wound events, intraoperative complications, and one-year 
hernia recurrence:  Outcomes will be compared using Pearson’s chi-square. 
A two-tailed test with p-value <0.05 will be considered statistically significant.  All 
statistical calculations will be performed with SAS, version 9.1. 
DATA SAFETY MONITORING BOARD 
 
A data safety monitoring board will oversee the progress of this trial. This board will 
be comprised of surgeons and statisticians from the Cleveland Clinic Foundation. This group of 
individuals will meet at regular intervals to monitor the safety and progression of this trial.  
 
CLINICAL SIGNIFICANCE/INNOVATION 
Both the use of a balloon dissector and the telescopic dissection are well accepted and 
largely performed manners to create the extraperitoneal space for laparoscopic TEP repairs. The 
use of the balloon dissector depends on institutional availability, surgeon preference, and 
expertise. Both arms evaluated in this study represent a well-accepted technique for laparoscopic 

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TEP repair.  Nevertheless, to date, a cost effectiveness, time savings, or pain reduction analysis 
using the balloon dissector in experienced surgeons hands has not been performed.  Besides 
conferring shorter operative time and lower conversion rates for surgeons at an early point of the 
learning curve, the use of the balloon dissector might be deferred in experienced hands, 
decreasing direct costs without impairing quality, patient safety and value of hernia repair.  
As previously mentioned, this trial will be another registry-based randomized prospective 
study performed in the hernia disease space by our institution. Registry-based clinical trials have 
recently been proposed as a way to achieve the scientific power of an RCT while minimizing the 
cumbersome nature often associated with running such a trial. In effect, the registry-based trial 
allows for faster accrual of patients and secure data storage with a reduced financial burden.  
REFERENCES 
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