Clinical trial NCT03434301: Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™
Official title: Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia - ReliaTack™ v ProTack™ (TACKoMesh Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Hernia
Abdominal Hernia
Keywords: Surgery
Laparotomy
Tack
Non-absorbable Tack
Absorbable Tack
Pain
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Medtronic
First posted: 2018-02-15
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to examine the effects on post operative pain after the use of a fixation device to secure a mesh in the abdomen to repair a hernia of the abdominal wall. The fixation devices to be used differ with one being made from titanium and is permanent and the other being made from an absorbable material. Both fixation devices are commonly used but two questions remain unanswered, does one cause more chronic pain and also what if any will be the effect on recurrence rates of the hernia. No trial has been undertaken to date which will not only examine the fixation device but in the setting where the hernia is closed first. The closure of the hernial defect by the keyhole technique is a relatively new and growing concept in the hernia world.

Detailed description: TACKoMESH study (Comparison of using absorbable tacks (ReliaTack™) against a non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia) is a prospective, single-centre, double blinded randomised trial which aims to establish whether the use of absorbable (ABS) compared to non-absorbable (Non-ABS) tacks in adult patients undergoing elective incisional hernia repair produces a lower rate of pain both immediately and long-term. Secondary outcomes to be explored include seroma formation, hernia recurrence, length of postoperative hospital stay, wound infection, reoperation rate, operation time, health related quality of life and time to return to normal daily activity.

Patients entering TACKoMesh will be randomised immediately prior to their operation with a 1:1 ratio of ABS versus Non-ABS tack arm allocation. The same composite mesh will be used for all operations. Follow-up is according to a predetermined schedule, using specifically designed Case Report Forms to collect the blinded data.

Eligibility criteria: Inclusion Criteria:

• All adults undergoing elective incisional hernia repair for midline abdominal incisional hernia, with a defect of 3-10cm in diameter.

Exclusion Criteria:

* Patients less than 18 years of age, or unable to give informed consent.
* Patients over 80 years of age.
* Females of reproductive age.
* Prisoners.
* Clinically small incisional hernia \<3cm maximum diameter.
* Emergency procedures (for irreducible, strangulated or obstructed hernia).
* Procedure involving dirty (purulent inflammation (e.g. abscess); preoperative perforation of respiratory, gastrointestinal, biliary or genitourinary tract; penetrating trauma \>4 hours old) or contaminated (Non-purulent inflammation; gross spillage from gastrointestinal tract; entry into biliary or genitourinary tract in the presence of infected bile or urine; major break in technique; penetrating trauma \<4 hours old; chronic open wounds to be grafted or covered) surgery.
* Patients with a Body Mass Index (BMI) \>40 kg/m².
* Patients participating in any other study, whose concurrent participation in the TACK study might place them at undue risk or might confound the study data in the opinion of the chief investigators.
* Failure to close the anterior rectus sheath intraoperatively.

Primary outcomes:
measure: Pain score
timeFrame: 30 days
Secondary outcomes:
measure: Visual analogue pain score (VAS).
timeFrame: Day 1, days 5-7, 3 months, 1 year.
measure: Seroma formation.
timeFrame: Days 1, 6, 30, 3 months and 1 year post-operation.
measure: Postoperative hospital stay.
timeFrame: Time from end of Surgery to patient discharge (up to end of study; 104 weeks).
measure: Time to return to normal daily activity.
timeFrame: From day of surgery to end of study (104 weeks).
measure: Wound infection.
timeFrame: Days 1, 6, 30, 3 months and 1 year post-operation.
measure: Operating time.
timeFrame: Length of Operation.
measure: Mesh fixation time.
timeFrame: Time during Operation.
measure: Hernia recurrence.
timeFrame: Days 1, 6, 30, 3 months and 1 year post-operation.
measure: Health-related quality of life.
timeFrame: 30 days and 1 year post-operation.
measure: Adverse Events.
timeFrame: Days 1, 6, 30, 3 months and 1 year post-operation.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Aali J Sheen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheen AJ, Pilkington JJ, Baltatzis M, Tyurkylmaz A, Stathakis P, Jamdar S, Siriwardena AK. Comparison of Mesh Fixation Techniques in Elective Laparoscopic Repair of Incisional Hernia-ReliaTack v ProTack (TACKoMesh) - A double-blind randomised controlled trial. BMC Surg. 2018 Jul 11;18(1):46. doi: 10.1186/s12893-018-0378-3.