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

NCT03276871 | Completed Results FDA Device

• 1 other identifier: 17-1045
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia

Keywords

Balloon dissection; Telescopic dissection; Inguinal hernia; TEP

Outcome Measures

Primary Outcomes (1)

• 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 from start to end of procedure

Secondary Outcomes (3)

• NRS-11 Pain Scores

  Postoperative day 1, Postoperative day 7 and Postoperative day 30

• Number of Participants With Intra-operative Complications

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

• 30-day SSO (Surgical Site Occurrences) Rate

  30 days after surgery

Study Arms (2)

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.

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.

Procedure: Telescopic Dissection

Interventions

Telescopic Dissection PROCEDURE

Creation of extraperitoneal space with blunt dissection using the laparoscopic probe

Telescopic Dissection

Balloon Dissection DEVICE

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

Also known as: SpaceMaker Balloon Dissector

Balloon Dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Comprehensive Hernia Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (5)

• 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.

  PMID: 22538696 BACKGROUND

• Ferzli 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.

  PMID: 1489992 BACKGROUND

• Bringman 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.

  PMID: 11344426 BACKGROUND

• Poulose 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.

  PMID: 26936373 BACKGROUND

• Tastaldi 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.

  PMID: 31388790 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Aldo Fafaj
• Organization: Cleveland Clinic

fafaja@ccf.org

2162195943

Study Officials

• Michael J Rosen, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 8, 2017
• Study Start: August 28, 2017
• Primary Completion: July 6, 2019
• Study Completion: July 6, 2019
• Last Updated: July 22, 2020
• Results First Posted: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)