Dataset Information

Use of human fibrin glue (Tisseel) versus staples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty (TISTA): a randomized controlled trial (NCT01641718).

ABSTRACT: Inguinal hernia repair is one of the most common surgical procedures worldwide. This procedure is increasingly performed with endoscopic techniques (laparoscopy). Many surgeons prefer to cover the hernia gap with a mesh to prevent recurrence. The mesh must be fixed tightly, but without tension. During laparoscopic surgery, the mesh is generally fixed with staples or tissue glue. However, staples often cause pain at the staple sites, and they can cause scarring of the abdominal wall, which can lead to chronic pain. We designed a trial that aims to determine whether mesh fixation with glue might cause less postoperative pain than fixation with staples during a transabdominal preperitoneal patch plastic repair.The TISTA trial is a prospective, randomized, controlled, single-center trial with a two-by-two parallel design. All patients and outcome-assessors will be blinded to treatment allocations. For eligibility, patients must be male, ?18 years old, and scheduled for laparoscopic repair of a primary inguinal hernia. One group comprises patients with a unilateral inguinal hernia that will be randomized to receive mesh fixation with either tissue glue or staples. The second group comprises patients with bilateral inguinal hernias. They will be randomized to receive mesh fixation with tissue glue either on the right or the left side and with staples on the other side. The primary endpoint will be pain under physical stress, measured at 24 h after surgery. Pain will be rated by the patient based on a numeric rating scale from 0 to 10, where 10 equals the worst pain imaginable. A total of 82 patients will be recruited (58 patients with unilateral inguinal hernias and 24 patients with bilateral hernias). This number is estimated to provide 90% power for detecting a pain reduction of one point on a numeric rating scale, with a standard deviation of one.Patients with bilateral hernias will receive two meshes, one fixed with glue, and the other fixed with staples. This design will eliminate the inter-individual bias inherent in comparing pain measurements between two groups of patients.ClinicalTrials.gov: NCT01641718.

SUBMITTER: Muller SA

PROVIDER: S-EPMC3994239 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Use of human fibrin glue (Tisseel) versus staples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty (TISTA): a randomized controlled trial (NCT01641718).

Müller Sascha A SA Warschkow Rene R Beutner Ulrich U Lüthi Cornelia C Ukegjini Kristjan K Schmied Bruno M BM Tarantino Ignazio I

BMC surgery 20140401

<h4>Background</h4>Inguinal hernia repair is one of the most common surgical procedures worldwide. This procedure is increasingly performed with endoscopic techniques (laparoscopy). Many surgeons prefer to cover the hernia gap with a mesh to prevent recurrence. The mesh must be fixed tightly, but without tension. During laparoscopic surgery, the mesh is generally fixed with staples or tissue glue. However, staples often cause pain at the staple sites, and they can cause scarring of the abdominal ...[more]

PMID: 24690207

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Project description:BACKGROUND:Technical factors leading to hernia recurrence after transabdominal preperitoneal repair include insufficient dissection, inadequate prosthetic overlap and prosthetic size, improper fixation and folding, or crinkling of the prosthesis. However, determining intraoperatively if a case will develop recurrent hernias due to these factors remains unclear. METHODS:Five surgeons blind-reviewed operation videos of primary laparoscopic hernioplasty in 13 lesions that went on to develop recurrent hernias (i.e., future recurrence), as well as 28 control lesions, to assess twelve items of surgical techniques. Since we changed a surgical policy of covering myopectineal orifice (MPO) in April 2003, we analyzed the data for the earlier and later periods. The data was analyzed with hierarchical clustering to obtain a gross grouping. The differences of the ratings between the future recurrent and control lesions were then analyzed and the association of the techniques with the hernia recurrence rate, the size of the prosthesis, and the hernia type across hernia recurrence were explored. RESULTS:The lesions were grouped based on the time series, and its boundary was approximated when we changed our surgical policy. This policy change caused ratings to progress from 34% satisfactory, to 79% satisfactory. The recurrence rate decreased to 0.7% (5/678), compared with 6.2% (10/161) before the policy was implemented (p?<?0.001). With univariate analysis, the ratings of posterior prosthesis overlap to the MPO in the recurrent lesions were significantly lower than controls in the later period (p?=?0.019). Although various types of recurrences were noted in the earlier period, only primary indirect and recurrent indirect hernias were observed in the later period (p?=?0.006). CONCLUSIONS:Fully covering the MPO with mesh is essential for preventing direct recurrence hernias. Additional hernia recurrence prevention can be obtained by giving appropriate attention to prosthesis overlap posterior to the MPO in a large indirect hernia.

Dataset Information

Use of human fibrin glue (Tisseel) versus staples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty (TISTA): a randomized controlled trial (NCT01641718).

Publications

Use of human fibrin glue (Tisseel) versus staples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty (TISTA): a randomized controlled trial (NCT01641718).

Similar Datasets

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