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Use of Human Fibrin Glue Versus Staples for Mesh Fixation in Laparoscopic Transabdominal Preperitoneal Hernioplasty (TISTA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01641718
First Posted: July 17, 2012
Last Update Posted: April 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sascha Müller, Cantonal Hospital of St. Gallen
  Purpose

Inguinal hernia repairs belong to the most common surgical procedures worldwide. Increasingly they are performed using endoscopical techniques (laparoscopy). Many surgeons prefer to cover the hernia gap with a mesh to prevent recurrence. For it, the mesh must be fixed tightly, but tension free. During laparoscopic surgery the mesh is fixed commonly with staples or tissue glue. However, it is not uncommon that staples cause pain at the staple sites while moving. In addition, staples can cause scarring of the abdominal wall leading to chronic pain.

Aim of the study is to provide evidence that mesh fixation with tissue glue causes less postoperative pain compared to fixation with staples.

Patients with unilateral inguinal hernia will be randomized to receive either mesh fixation with tissue glue or staples (ratio 1:1).

Patients with bilateral inguinal hernia will receive mesh fixation with tissue glue on one side and staple fixation on the other side. The side treated with tissue glue will be randomized (ratio 1:1).


Condition Intervention
Hernia, Inguinal Drug: Tissue glue Device: Staples

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Use of Human Fibrin Glue (Tisseel) Versus Staples for Mesh Fixation in Laparoscopic Transabdominal Preperitoneal Hernioplasty (TISTA)

Resource links provided by NLM:


Further study details as provided by Sascha Müller, Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Pain after physical stress [ Time Frame: 24 h after surgery ]

    Patient rates his pain on a scale from 0 to 10 (10 equals worst pain imaginable). (NRS numeric rating scale).

    Patient will be asked to bend the hip joint for 90° on the operated side (both sides for patients with bilateral hernia). Then they are asked for the pain rating (physical stress measurement).



Secondary Outcome Measures:
  • Pain at rest [ Time Frame: 4, 8, 16, 24, 32, 48 h & 1 month after surgery ]

    Patient rates his pain on a scale from 0 to 10 (10 equals worst pain imaginable). (NRS numeric rating scale).

    Patient is interviewed for pain at rest before pain measurement after physical stress.


  • Pain after physical stress [ Time Frame: 4, 8, 16, 32, 48 h & 1 month after surgery ]

    Patient rates his pain on a scale from 0 to 10 (10 equals worst pain imaginable). (NRS numeric rating scale).

    Patient will be asked to bend the hip joint for 90° on the operated side (both sides for patients with bilateral hernia). Then they are asked for the pain rating (physical stress measurement).


  • Operating time [ Time Frame: 4 h ]
    Time in minutes from the first skin incision to the application of dressing.

  • Length of hospital stay [ Time Frame: 2 weeks ]
    Time in days (with one decimal) from start of surgery to hospital release.

  • Postoperative analgetic requirements [ Time Frame: 1 month ]
    Amount (g/day) and type (paracetamol, metamizol, morphin) of analgesic required after surgery until hospital discharge.

  • Incidence of persisting pain (neuralgia) [ Time Frame: 1 month ]

    Persisting pain (neuralgia) is defined by the presence of intermittent hyperesthesia, burning sensation or jabbing pain in the ipsilateral inguinal area nerves (genitofemoral nerve, lateral cutaneous femoral nerve, ilioinguinal and iliohypogastric nerve).

    Evaluation for chronic pain (neuralgia) will be performed during the 1 month follow-up visit. The degree of pain will measured as described above.


  • Postoperative morbidity [ Time Frame: 1 month ]
    • Wound infection (defined as those treated without further surgery and identified by clinical examination without microbiological confirmation)
    • haematoma or seroma formation (identified by clinical examination alone before discharge from hospital, without the requirement for radiological confirmation)
    • Re-operation (Need for re-operation during patients' initial hospital stay)
    • Bleeding
    • Urinary retention, urinary tract infection
    • Pulmonary infection
    • Any serious deviation from the normal postoperative course

  • Medical leave of absence [ Time Frame: 2 months ]
    Time in days from hospital discharge to first working day. All patients will be encouraged to return to work as soon as possible, irrespective of their profession. Time to return to work will be obtained during 1 month follow-up visit. If still on medical leave of absence at this time, patients will be later contacted by phone to obtain the day of return to work. Depending on the expected course of recovery these calls will be performed in a weekly or biweekly fashion.

  • Economic impact [ Time Frame: 2 months ]

    Will be calculated using the following factors:

    • Cost for glue, staples and instruments to apply glue or staples
    • If relevant: cost for increased operating time for the "slower" mesh fixation technique
    • length of hospital stay (cost/day)
    • medical leave of absence (converted into a monetary amount using an average salary)


Enrollment: 82
Study Start Date: January 2013
Study Completion Date: December 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single sided glue
Mesh is fixed with Tisseel for single sided inguinal hernias.
Drug: Tissue glue
The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with 2 mL of tissue glue.
Other Name: Tisseel (Baxter)
Active Comparator: Single sided stapled
Mesh is fixed with staples for single sided inguinal hernias.
Device: Staples
The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with ProTack (Covidien) and Securestrap (Ethicon) staples.
Other Names:
  • ProTack (Covidien)
  • Securestrap (Ethicon)
Bilateral glue right

For bilateral inguinal hernias mesh on the right side is fixed with Tisseel, on the left with staples.

Experimental treatment and active comparator in the same patient.

Drug: Tissue glue
The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with 2 mL of tissue glue.
Other Name: Tisseel (Baxter)
Device: Staples
The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with ProTack (Covidien) and Securestrap (Ethicon) staples.
Other Names:
  • ProTack (Covidien)
  • Securestrap (Ethicon)
Bilateral glue left

For bilateral inguinal hernias mesh on the left side is fixed with Tisseel, on the right with staples.

Experimental treatment and active comparator in the same patient.

Drug: Tissue glue
The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with 2 mL of tissue glue.
Other Name: Tisseel (Baxter)
Device: Staples
The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with ProTack (Covidien) and Securestrap (Ethicon) staples.
Other Names:
  • ProTack (Covidien)
  • Securestrap (Ethicon)

Detailed Description:

______________________________________________

The inguinal hernia is the most common hernia, including 90% of all spontaneous hernias, and the inguinal hernia repair is the most frequently performed procedure in general surgery. In the United States more than 700,000 inguinal hernias are repaired annually and in Germany more than 200,000. The standard method for inguinal hernia repair, originally described by Bassini in 1889, is the closure of the inguinal canal using sutures. Due to the high recurrence rate of this technique, methods using the tension-free implantation of synthetic meshes were established. Furthermore, endoscopic/laparoscopy methods were established, in which the hernia canal is usually approached from the posterior side opposite to the anterior site in the open approach. It is still hotly debated which of these approaches and methods is the best. Among the various posterior techniques using preperitoneal mesh implantation, the transabdominal preperitoneal patch plastic repair (TAPP) and the total extraperitoneal (TEP) repair achieved the highest acceptance. There are many indications for the use of both techniques, but the TAPP is recommended especially for recurrent hernias (after open preperitoneal patch plastic) and difficult hernias (sliding or incarcerated hernias). The advantages of the TAPP are that it is easier to perform, has a better possibility of standardization, and offers the option to perform a diagnostic laparoscopy. Thus, the type of hernia can be assessed immediately on both sides and a bilateral repair can be performed without additional incisions. In general, learning TAPP is easier than TEP. Most randomized studies comparing laparoscopic with open repair found the following results for laparoscopy: reduced postoperative pain, earlier return to work, increased costs, increased operating time, longer learning period, and during the early learning phase an increased recurrence and complication rate. In summary open, mesh-based, tension-free repair remains the standard, but laparoscopic herniorrhaphy, in the hands of adequately trained surgeons, produces excellent results comparable to those of open repair.

Whether patients suffer from postoperative pain depends on many factors like the type of intervention, complications, age, and individual tolerance. In particular the type of mesh fixation employed during hernioplasty has a strong influence on postoperative pain. In a recent review mesh fixation by glue was compared to mesh fixation with staplers during endoscopic inguinal hernia repair (Surg Laparosc Endosc Percutan Tech (2010) 20:205). For the transabdominal preperitoneal patch plastic repair two randomized controlled trials, one non randomized trial and two case series were identified in this review. Although the authors found reduced postoperative pain and faster recovery after glue fixation without any significant difference in the recurrence rate, the authors still concluded: "As the overall quality of published data remains poor, further well-designed studies are needed until fibrin sealing can replace mechanical stapling as a new standard for mesh fixation." Thus well designed randomized studies comparing glue vs. staples fixation during TAPP are still warranted. Most of the previous studies applied only one mesh fixation method for patients with bilateral hernias. Only one study compared glue and stapler fixation in single patients with bilateral hernias. In this study a 2x2 design will be used, to compare the two fixation methods in patients with unilateral hernia as well as to compare the two methods in the same patient with bilateral hernias, eliminating the interindividual bias of the single hernia group. Furthermore this study focuses on the early postoperative pain, with a rather thorough coverage in the first 2 days. In many other studies the first time pain is measured is one month after surgery, which is the last time point in this study.

The main aim of this trial is to investigate the early postoperative pain after laparoscopic hernia repair in TAPP technique using either fibrin glue or staples for mesh fixation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary hernia repair (no re-operation for recurrent hernia)
  • good compliance can be expected
  • informed consent

Exclusion Criteria:

  • chronic pain
  • acute pain requiring analgesic others than paracetamol or more than a single dose non-steroidal anti-inflammatory drugs treatment within 48 h before surgery
  • current treatment with psychopharmaceutical drugs
  • mental incapacity
  • known incompatibility (allergies) with the Tisseel compounds
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641718


Locations
Switzerland
Cantonal Hospital St.Gallen
St.Gallen, Switzerland, 9007
Sponsors and Collaborators
Sascha Müller
Investigators
Principal Investigator: Sascha A Müller, MD Cantonal Hospital St.Gallen
  More Information

Additional Information:
Publications:
Responsible Party: Sascha Müller, Oberarzt (attending physician), Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT01641718     History of Changes
Other Study ID Numbers: TISTA
First Submitted: June 29, 2012
First Posted: July 17, 2012
Last Update Posted: April 15, 2016
Last Verified: April 2016

Keywords provided by Sascha Müller, Cantonal Hospital of St. Gallen:
Hernia, Inguinal

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Fibrin Tissue Adhesive
Hemostatics
Coagulants