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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
| Pr Giampiero CAMPANELLI | UNKNOWN |
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The purpose of the study is to evaluate mid and long term postoperative pain and further disabling complications in open inguinal hernia repair by Lichtenstein technique after mesh fixation with fibrin sealant (FS), compared to mesh fixation with sutures.
Subjects in the FS group will be operated by Lichtenstein technique, with mesh fixation by fibrin sealant. Subjects in control group will be operated with conventional Lichtenstein technique (mesh fixation by sutures).
Hernia repair will be performed according to standardized Lichtenstein technique, a technique for tension free hernioplasty. A Polypropylene, heavyweight, macroporous mesh will be used (8x15 cm) tailored to individual patients requirement. The different ways of mesh fixation will be randomly assigned within 24 hours before the operation. In the FS group, the two tails of the mesh will be fixed together in overlapping their edges and by surrounding the cord. The edges will be joined up to by 1 suture. No other sutures will be used. First the mesh will be put correctly in place. A small spot (0.5ml) of FS will be applied on the pubis under the mesh without spray then the remaining part (3,5ml) over the mesh on the entire surface in a thin uniform layer by spray. 2 ml Tissucol-Tisseel (4 ml of fibrin sealant) will be used per mesh. In the control group, the mesh will be fixed in a conventional manner. Nerve resection (if occurred) will be recorded; it should be avoided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Tissel group |
|
| 2 | Other | Suture group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standardized Lichtenstein technique | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Combined endpoint evaluating incidence of disabling complications:chronic pain and/or numbness and/or groin discomfort assessed 1 year after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence | ||
| Overall wound-healing complication rate (bleeding complications, bruising, seroma, wound infection, mesh infection) | ||
| Early postoperative pain at W1 and M1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CAMPANELLI Giampiero, Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gasthuisberg University Hospitals KUL | Leuven | 3000 | Belgium | |||
| Copenhagen university hospital, Gentofte |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22395092 | Derived | Campanelli G, Pascual MH, Hoeferlin A, Rosenberg J, Champault G, Kingsnorth A, Miserez M. Randomized, controlled, blinded trial of Tisseel/Tissucol for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: results of the TIMELI trial. Ann Surg. 2012 Apr;255(4):650-7. doi: 10.1097/SLA.0b013e31824b32bf. |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Mid-term postoperative pain at M6 |
| Incidence of patients without pain at M1, M6 and M12 |
| Use of analgesic drugs |
| Patient's satisfaction |
| Safety (incidence of adverse events) |
| Quality of Life assessed by SF12 pre-operatively or at D-1, M1, M6 and M12 |
| Hospital stay (hour or Days) and time to return to normal activities |
| A subgroup analysis will be done for patients receiving pre-operatively aspirin or LMW sub-cutaneous heparin. |
| The study will be blinded for the patient and for the physician evaluating the pain. |
| Hellerup |
| 2900 |
| Denmark |
| Hôpital Jean Verdier | Bondy | 93143 | France |
| St. Hildegardis-Krankenhaus | Mainz | 55131 | Germany |
| Clinica Nuestra Senora del Rosario | Madrid | 28006 | Spain |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |