Abdominal surgery Digestive System Intra-abdominal pathologic diseases
Conditions
Interventions
After randomisation either in the transverse or in the vertical (= midline) group a standardised surgical abdominal approach is performed. Further surgical procedure in the vertical as well in the tra
Sponsors
University of Heidelberg Medical School (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Hospitalised patients of the Department of General-, Visceral-, Traumasurgery and Outpatient Clinic of the University of Heidelberg, Medical School, who are planned for an elective abdominal operation and are suitable for both transverse and vertical incision. 1. Age equal or greater than 18 years 2. Expected survival time more than 12 months 3. Patients scheduled for the following procedures: a) Whipple procedure (classic or pylorus-preserving) b) Duodenum-preserving resection of the pancreatic head c) Gastrectomy (partial or total gastrectomy) d) Colon resection (left or right or transverse / classic or extended) e) Ileocecal resection 4. Primary and elective laparotomy 5. Patient must be able to give informed consent 6. Patient has given informed consent
Exclusion criteria
Exclusion criteria: 1. Permanent therapy with a opioid equivalent drug for any reason within 12 months before operation (duration longer than 2 weeks) 2. Incompatibility of metamizole 3. Recurrent opening of the abdominal cavity (not laparoscopic appendectomy, laparoscopic cholecystectomy, laparoscopic adrenalectomy, diagnostic laparoscopy or appendectomy), including prior cesarean section and Pfannenstiel incision (e.g., hysterectomy) 4. Participation in another intervention trial that would interfere with the intervention and outcome of this study 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 azathioprine) 9. Chemotherapy within 2 weeks before operation 10. Radiotherapy of the abdomen completed longer than 8 weeks before operation (except for neoadjuvant therapy, e.g. for pancreatic cancer) 11. Liver, gallbladder, spleen, and rectum surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the abdominal pain intensity experienced by a patient, quantified with the Visual Analogue Scale (VAS), and the amount of analgesic required (piritramide [mg/h]) on the second postoperative day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are the frequencies of early- and late-onset complications such as burst abdomen, postoperative pulmonary complications, wound infections and incisional hernias. In addition, pain is quantified according to the Pain-Sensation-Scale by Geissner, a modified McGill Pain Questionnaire, designed for studies conducted in Germany. | — |
Countries
Germany
Outcome results
None listed