Abdominal surgery Surgery Primary median laparotomy
Conditions
Interventions
A standardised surgical approach for opening of the abdomen is performed in all patients with a midline incision of at least 15 cm length.
The randomisation will proceed when the operation has been f
Sponsors
BBD Aesculap GmbH (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged equal or greater than 18 years 2. Expected survival time more than 12 months 3. Patients undergoing primary and elective median laparotomy (patients with prior laparoscopy or abdominal operation via paramedian incision (e.g. appendectomy) may be included in the trial) 4. Body mass index (BMI) less than 35 5. Expected length of incision greater than 15 cm 6. Patient must be able to give informed consent 7. Patient has given informed consent
Exclusion criteria
Exclusion criteria: 1. Peritonitis 2. Emergency surgery 3. Participation in another intervention-trial with interference of intervention and outcome of this study 4. Coagulopathy: a group of disorders of the blood clotting (coagulation) system in which bleeding is prolonged and excessive with abnormal values in the blood laboratory 5. Severe psychiatric or neurologic diseases 6. Lack of compliance 7. Drug- and/or alcohol-abuse according to local standards 8. Current immunosuppressive therapy (more than 40 mg of a corticoid per day or azathioprin) 9. Chemotherapy within 2 weeks before operation 10. Radiotherapy of the abdomen completed longer than 8 weeks before operation 11. Inability to follow the instructions given by the investigator or the telephone interviewer (insufficient command of language, dementia, lack of time) 12. Lack of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of incisional hernias between three different abdominal fascia closure methods after one year postoperatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequencies of early and late onset complications such as burst abdomen, postoperative pulmonary complications, wound infections and incisional hernias after three years postoperatively. | — |
Countries
Germany
Outcome results
None listed