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Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair

Randomized Controlled Trial Comparing Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03276871
Enrollment
40
Registered
2017-09-08
Start date
2017-08-28
Completion date
2019-07-06
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Balloon dissection, Telescopic dissection, Inguinal hernia, TEP

Brief summary

The purpose of this study is to determine if the surgical technique for creation of extraperitoneal space during laparoscopic TEP inguinal hernia repair (telescopic dissection or balloon dissection) has an impact on operative times, early postoperative pain scores, surgical complications and rate of hernia recurrence following laparoscopic TEP inguinal hernia repair.

Detailed description

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. 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. 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. A key step in the TEP procedure is the creation of the extraperitoneal space, which can be performed by two different techniques: telescopic dissection or balloon dissection.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. To date, telescopic dissection is still used in many centers around the globe. 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. A randomized, prospective multicenter study conducted between 1994 and 1997 and published in 2001 by Bringmam and colleagues 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 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. 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. The investigator's institution has in its staff, three expert surgeons, with a robust experience in the TEP procedure, performed either telescopic or balloon dissection. To help determine if the use of the balloon dissector is associated with a significant decrease in operative times when compared to telescopic dissection, the investigators 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. 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. The investigators hypothesize that at their 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. 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 Specific Aim #2: 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 #3: 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 performed either with telescopic dissection or balloon dissection. Specific Aim #4: 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.

Interventions

PROCEDURETelescopic Dissection

Creation of extraperitoneal space with blunt dissection using the laparoscopic probe

DEVICEBalloon Dissection

Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years of age or older * Able to give informed consent * Unilateral inguinal hernia * Scheduled for elective inguinal hernia repair * Eligible to tolerate general anesthesia * Eligible to undergo minimally invasive inguinal hernia repair * Willing to undergo mesh-based repair

Exclusion criteria

* Younger than 18 years old * Unable to give informed consent * Bilateral Inguinal hernias * Emergent inguinal hernia repairs ( acute incarceration or strangulation) * Recurrent inguinal hernia with prior preperitoneal mesh * Unable to tolerate general anesthesia * Not eligible for minimally invasive inguinal hernia repair * Not willing to undergo mesh-based repair

Design outcomes

Primary

MeasureTime frameDescription
Operative TimeMeasured from start to end of procedureTotal Operative time measured in minutes, from incision to end of procedure; operative times will be reported as median and interquartile range.

Secondary

MeasureTime frameDescription
NRS-11 Pain ScoresPostoperative day 1, Postoperative day 7 and Postoperative day 30Early postoperative pain scores; Pain scores measured with the Numeric Pain Rating Scale (NRS-11) pain score at postoperative days 1, 7 and 30. Pain ratings will be reported as median and inter-quartile range. Scores can range from 0 to 10, higher numbers represent more pain.
Number of Participants With Intra-operative ComplicationsIntraoperative complications recorded during the procedure, up to closure of the incisionsRate of any Intra-operative complications; rate will be reported in number and percent as appropriate
30-day SSO (Surgical Site Occurrences) Rate30 days after surgery30-day rate of Surgical Site Occurrences which includes any surgical site infection as well as wound cellulitis, non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous drainage, seroma, hematoma, or development of an enterocutaneous fistula. The rate will be reported in number and percent as appropriate

Countries

United States

Participant flow

Participants by arm

ArmCount
Balloon Dissection
Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a balloon dissection technique using the Spacemaker Balloon Dissector. Balloon Dissection: Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector
21
Telescopic Dissection
Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique. Telescopic Dissection: Creation of extraperitoneal space with blunt dissection using the laparoscopic probe
19
Total40

Baseline characteristics

CharacteristicBalloon DissectionTelescopic DissectionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants9 Participants14 Participants
Age, Categorical
Between 18 and 65 years
16 Participants10 Participants26 Participants
BMI26 kg/m^225.7 kg/m^225.9 kg/m^2
COPD2 Participants0 Participants2 Participants
Diabetes0 Participants2 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants3 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
20 Participants16 Participants36 Participants
Sex: Female, Male
Female
20 Participants19 Participants39 Participants
Sex: Female, Male
Male
1 Participants0 Participants1 Participants
Smoking5 Participants2 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 19
other
Total, other adverse events
0 / 211 / 19
serious
Total, serious adverse events
0 / 211 / 19

Outcome results

Primary

Operative Time

Total Operative time measured in minutes, from incision to end of procedure; operative times will be reported as median and interquartile range.

Time frame: Measured from start to end of procedure

ArmMeasureValue (MEDIAN)
Balloon DissectionOperative Time46 minutes
Telescopic DissectionOperative Time43 minutes
Secondary

30-day SSO (Surgical Site Occurrences) Rate

30-day rate of Surgical Site Occurrences which includes any surgical site infection as well as wound cellulitis, non-healing incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, wound serous drainage, seroma, hematoma, or development of an enterocutaneous fistula. The rate will be reported in number and percent as appropriate

Time frame: 30 days after surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Balloon Dissection30-day SSO (Surgical Site Occurrences) Rate4 Participants
Telescopic Dissection30-day SSO (Surgical Site Occurrences) Rate0 Participants
Secondary

NRS-11 Pain Scores

Early postoperative pain scores; Pain scores measured with the Numeric Pain Rating Scale (NRS-11) pain score at postoperative days 1, 7 and 30. Pain ratings will be reported as median and inter-quartile range. Scores can range from 0 to 10, higher numbers represent more pain.

Time frame: Postoperative day 1, Postoperative day 7 and Postoperative day 30

ArmMeasureGroupValue (MEDIAN)
Balloon DissectionNRS-11 Pain ScoresNRS-11, Postop day 13 units on a scale
Balloon DissectionNRS-11 Pain ScoresNRS-11, Postop day 72 units on a scale
Balloon DissectionNRS-11 Pain ScoresNRS-11, 30-day0.5 units on a scale
Telescopic DissectionNRS-11 Pain ScoresNRS-11, Postop day 14 units on a scale
Telescopic DissectionNRS-11 Pain ScoresNRS-11, Postop day 71.5 units on a scale
Telescopic DissectionNRS-11 Pain ScoresNRS-11, 30-day0 units on a scale
Secondary

Number of Participants With Intra-operative Complications

Rate of any Intra-operative complications; rate will be reported in number and percent as appropriate

Time frame: Intraoperative complications recorded during the procedure, up to closure of the incisions

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Balloon DissectionNumber of Participants With Intra-operative Complications1 Participants
Telescopic DissectionNumber of Participants With Intra-operative Complications0 Participants

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026