cholecystolithiasis gallstones
Conditions
Interventions
One group of patients will undergo surgery under normal (fully sterile) 
conditions, while the other group of patients will undergo surgery under 
maximally hygienic conditions.
Sponsors
Deventer Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients older than 18 years - Patients that will undergo a planned laparoscopic cholecystectomy due to non-complicated gallstone disease
Exclusion criteria
Exclusion criteria: - Patients undergoing an emergency surgery (48h). - Patients with complicaties gallstone disease, such as cholecystitis, pancreatitis or cholangitis. - Patients that have undergone an ERCP with papilotomy or stenting of the common bile duct. - Patients that have had an invasive intervention or surgery within one week before the laparoscopic cholecystectomy. - Patients that use medication that are immunosuppressive (e.g. methotrexate or monoclonal antibodies). - Patients that have an active form of disease that need treatment with chemotherapy, immunotherapy or radiotherapy. - Patients that chronically use antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the development of postoperative (wound) infection(s). This will be assessed using the following measurement points: - Each patient will undergo a regular physical checkup two weeks after the operation at the wound clinic, where a wound score will be determined using the validated 'Southampton Wound Assessment Scale.' - If a patient undergoes wound assessment earlier, the above method will be used for scoring. - If a patient develops a wound infection later than the scheduled wound assessment but within 30 days, the above score will also be used. - Other procedure-related infections, such as peritoneal infection, will be scored using the Clavien-Dindo classification. - The surgeon will note whether there has been spillage of bile or gallstones for each patient. The severity of the recorded wound infections will be assessed using the Southampton Wound Assessment Scale, a categorical method of recording the severity of infection. This severity will also be related to patient factors, such as underlying comorbidities, with patient information collected from the electronic medical record. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Saved costs: The saved costs of the maximal hygiene method compared to the sterile method, including the treatment of any complications, will be documented and analyzed. This will include saved material costs during surgery, costs of readmissions, costs of bacterial culturing and costs of treatment of surgical site infections. This will be from a hospital perspective. - Sustainability: The reduction in waste material (in kg) in the maximal hygiene method compared to the sterile method will be documented and analyzed. The reduction in impact on the climate will be calculated in grams CO2 | — |
Countries
Netherlands
Outcome results
None listed