Inguinal HerniaNCT03276871
Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair
A study testing Telescopic Dissection and Balloon Dissection in people with Inguinal Hernia, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Telescopic Dissection and Balloon Dissection
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2017to 6 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Comprehensive Hernia Center
Cleveland, Ohio, 44195
About this study
Official title: Randomized Controlled Trial Comparing Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair
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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Telescopic Dissection, Balloon Dissection
- Keywords
- Balloon dissection, Telescopic dissection, Inguinal hernia, TEP
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telescopic DissectionProcedure or surgery
Creation of extraperitoneal space with blunt dissection using the laparoscopic probe
Balloon DissectionDevice
Also called SpaceMaker Balloon Dissector
Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector
| Study group | Role | What they receive |
|---|---|---|
| Balloon Dissection | Active comparator | 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. Receives: Device: Balloon Dissection |
| Telescopic Dissection | Experimental | Patients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique. Receives: Procedure: Telescopic Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
Total Operative time measured in minutes, from incision to end of procedure; operative times will be reported as median and interquartile range.
Measured: Measured from start to end of procedure
Secondary outcomes (3)
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.
Measured: Postoperative day 1, Postoperative day 7 and Postoperative day 30
Number of Participants With Intra-operative Complications
Rate of any Intra-operative complications; rate will be reported in number and percent as appropriate
Measured: Intraoperative complications recorded during the procedure, up to closure of the incisions
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
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start28 Aug 2017
- Primary completion6 Jul 2019
- Study completion6 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Rosen, The Cleveland Clinic
- Investigators
- Michael J Rosen, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276871
- Sponsor's protocol ID
- 17-1045
- Status last verified
- Jul 2020
- First submitted
- 4 Sep 2017
- Last updated
- 22 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared, rather the results of the aggregate groups of patients will be shared
Publications
Berney CR. Guidelines for laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia. Surg Endosc. 2012 Nov;26(11):3350-1. doi: 10.1007/s00464-012-2293-5. Epub 2012 Apr 27. No abstract available.
PubMed 22538696Ferzli GS, Massad A, Albert P. Extraperitoneal endoscopic inguinal hernia repair. J Laparoendosc Surg. 1992 Dec;2(6):281-6. doi: 10.1089/lps.1992.2.281.
PubMed 1489992Bringman S, Ek A, Haglind E, Heikkinen T, Kald A, Kylberg F, Ramel S, Wallon C, Anderberg B. Is a dissection balloon beneficial in totally extraperitoneal endoscopic hernioplasty (TEP)? A randomized prospective multicenter study. Surg Endosc. 2001 Mar;15(3):266-70. doi: 10.1007/s004640000367. Epub 2001 Feb 27.
PubMed 11344426Poulose BK, Roll S, Murphy JW, Matthews BD, Todd Heniford B, Voeller G, Hope WW, Goldblatt MI, Adrales GL, Rosen MJ. Design and implementation of the Americas Hernia Society Quality Collaborative (AHSQC): improving value in hernia care. Hernia. 2016 Apr;20(2):177-89. doi: 10.1007/s10029-016-1477-7. Epub 2016 Mar 2.
PubMed 26936373Tastaldi L, Bencsath K, Alaedeen D, Rosenblatt S, Alkhatib H, Tu C, Fafaj A, Krpata DM, Prabhu AS, Petro CC, Rosen MJ. Telescopic dissection versus balloon dissection for laparoscopic totally extraperitoneal inguinal hernia repair (TEP): a registry-based randomized controlled trial. Hernia. 2019 Dec;23(6):1105-1113. doi: 10.1007/s10029-019-02001-y. Epub 2019 Aug 6.
PubMed 31388790
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Telescopic Dissection vs. Balloon Dissection During Laparoscopic TEP Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT03276871
- Acronym / sponsor ID
- 17-1045
- Conditions
- Inguinal Hernia
- Keywords
- Balloon dissection, Telescopic dissection, Inguinal hernia, TEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 6 Jul 2019 (actual)
- Study completion
- 6 Jul 2019 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Posted 22 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon Dissection | Active comparator | Device: Balloon DissectionPatients 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. |
| Telescopic Dissection | Experimental | Procedure: Telescopic DissectionPatients will undergo laparoscopic TEP inguinal hernia repair and creation of the extraperitoneal space will be performed with a telescopic dissection technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Telescopic DissectionCreation of extraperitoneal space with blunt dissection using the laparoscopic probe | Procedure or surgery | Telescopic Dissection |
| Balloon DissectionAlso: SpaceMaker Balloon DissectorCreation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector | Device | Balloon Dissection |
Primary outcome
Operative Time
Time frame: Measured from start to end of procedure
Total Operative time measured in minutes, from incision to end of procedure; operative times will be reported as median and interquartile range.
3 secondary outcomes
NRS-11 Pain Scores
Time frame: Postoperative day 1, Postoperative day 7 and Postoperative day 30
Number of Participants With Intra-operative Complications
Time frame: Intraoperative complications recorded during the procedure, up to closure of the incisions
30-day SSO (Surgical Site Occurrences) Rate
Time frame: 30 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22538696Berney CR. Guidelines for laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia. Surg Endosc. 2012 Nov;26(11):3350-1. doi: 10.1007/s00464-012-2293-5. Epub 2012 Apr 27. No abstract available.
- Background: PubMed 1489992Ferzli GS, Massad A, Albert P. Extraperitoneal endoscopic inguinal hernia repair. J Laparoendosc Surg. 1992 Dec;2(6):281-6. doi: 10.1089/lps.1992.2.281.
- Background: PubMed 11344426Bringman S, Ek A, Haglind E, Heikkinen T, Kald A, Kylberg F, Ramel S, Wallon C, Anderberg B. Is a dissection balloon beneficial in totally extraperitoneal endoscopic hernioplasty (TEP)? A randomized prospective multicenter study. Surg Endosc. 2001 Mar;15(3):266-70. doi: 10.1007/s004640000367. Epub 2001 Feb 27.
- Background: PubMed 26936373Poulose BK, Roll S, Murphy JW, Matthews BD, Todd Heniford B, Voeller G, Hope WW, Goldblatt MI, Adrales GL, Rosen MJ. Design and implementation of the Americas Hernia Society Quality Collaborative (AHSQC): improving value in hernia care. Hernia. 2016 Apr;20(2):177-89. doi: 10.1007/s10029-016-1477-7. Epub 2016 Mar 2.
- Derived from this study: PubMed 31388790Tastaldi L, Bencsath K, Alaedeen D, Rosenblatt S, Alkhatib H, Tu C, Fafaj A, Krpata DM, Prabhu AS, Petro CC, Rosen MJ. Telescopic dissection versus balloon dissection for laparoscopic totally extraperitoneal inguinal hernia repair (TEP): a registry-based randomized controlled trial. Hernia. 2019 Dec;23(6):1105-1113. doi: 10.1007/s10029-019-02001-y. Epub 2019 Aug 6.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, rather the results of the aggregate groups of patients will be shared
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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.
Michael J Rosen, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telescopic Dissection and Balloon Dissection in people with Inguinal Hernia, run by The Cleveland Clinic 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 7 inclusion and 8 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 22 Jul 2020. 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?
Yes. Results are posted in the registry (first posted 22 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Operative Time (time frame: Measured from start to end of procedure). 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 NCT03276871, which also lists 5 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 22 Jul 2020.