Postsurgical pain Outcome of Vertical And Transverse abdominal Incision: a randomised controlled equivalent Trial

Completed

Conditions: Abdominal surgery
Digestive System
Intra-abdominal pathologic diseases

Registration Number: ISRCTN60734227

Lead Sponsor: niversity of Heidelberg Medical School (Germany)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 172

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

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