Inguinal Hernia
Conditions
Brief summary
Collagen synthesis is depressed systemically in the immediate postoperative period. Arginine, zinc and vitamin C impact collagen synthesis. The aim of this study is to investigate the effect of a pre and postoperative oral supplement consisting of arginine, zinc and vitamin C on collagen synthesis in patients undergoing inguinal hernia repair.
Detailed description
The trial investigates the effect of a pre and postoperative oral supplement consisting of arginine, zinc and vitamin C on collagen type I synthesis in patients undergoing inguinal hernia repair. The patients in the intervention group are given 55 mg zinc, 1251 mg vitamin C, and 15 g arginine once daily 14 days pre-operatively and post-operatively. Both groups receive high quality protein (1.5 g protein/kg body weight) daily during the same period. Hernia repair is done using the Lichtenstein technique. Drainage tubes are placed in the wound during the surgery. Epidermal wounds (10 mm) are made via the suction blister method on the ventral forearm of the patients on the day of surgery. Blood samples are drawn at day -14, day 0, day 1 and day 2. The surgical drain is emptied and fluid collected at day 1 and day 2.The healing of the suction blisters is assessed by clinical criteria until healing.
Interventions
DIETARY_SUPPLEMENTIntervention
The patients in the intervention group are given 55 mg zinc, 1251 mg vitamin C, and 15 g arginine once daily 14 days pre-operatively and post-operatively together with a high quality protein supplement.
DIETARY_SUPPLEMENTControl
High quality protein supplement 14 days pre-operatively and post-operatively.
Sponsors
Lars Nannestad Jorgensen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age above 18 years * Patients undergoing hernia repair using the Lichtenstein technique * Written informed consent
Exclusion criteria
* Former surgery in the same area within 5 years * Dementia * Dysregulated diabetes * Systemic corticosteroid treatment * Liver disease * Kidney disease * Cancer within 5 years * Need of interpreter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in CICP levels in serum. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen) | Day 2 | CICP is measured by enzyme-linked immunosorbent assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in CICP levels in wound fluid collected from suction blisters. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen). | Day 0 | CICP is measured by enzyme-linked immunosorbent assay |
| Changes in Zinc levels in serum | Day -14, day 0, day 1 and day 2 | Zinc is measured by direct spectrophotometry |
| Changes in Zinc levels in wound fluid collected from surgical drain | Day 1 and day 2 | Zinc is measured by direct spectrophotometry |
| Changes in CICP levels in wound fluid collected from surgical drain. CICP is the biomarker of type I collagen synthesis (carboxy-terminal propeptide of type I procollagen). | Day 1 and day 2 | CICP is measured by enzyme-linked immunosorbent assay |
| Changes in Arginine levels in serum | Day -14, day 0, day 1 and day 2 | Arginine is measure by ultra-performance liquid chromatography and mass spectrometry |
| Healing of suction blisters | Day 3 to Suction Blister healing | Clinical assessment |
| Compliance | Day -14 to Suction Blister healing | Count of remaining supplement |
| Changes in Zinc levels in wound fluid collected from suction blisters | Day 0 | Zinc is measured by direct spectrophotometry |
Countries
Denmark
Outcome results
None listed