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| Name | Class |
|---|---|
| Bispebjerg Hospital | OTHER |
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The objective of this trial is to evaluate if intraoperative intraperitoneal administration of fosfomycin, metronidazole and recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) followed by oral antibiotic for three days is as effective as the current intravenous antibiotic treatment given during and three days after appendectomy for perforated appendicitis. The primary outcome is the total length of hospital stay, defined as the number of hours in hospital after end of operation and until 30-day follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of fosfomycin, metronidazole and rhGM-CSF (administered together intraperitoneally) and three days of antibiotics p.o. | Drug | All drugs will be administered together intraperitoneally at the end of the surgery after the appendix has been removed. Hereafter, the intervention group will receive three days of orally administered antibiotics: 500 mg amoxicillin combined with 125 mg clavulanic acid and 500 mg metronidazole. These doses will be administered three times daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Total length of hospital stay | in hours | From end of surgery until 30-days follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Quality of Life Index (GIQLI) | A disease-specific questionnaire validated in Danish is collected at 10 days postoperatively (±2 days) and at 30 days postoperatively (±3 days) | 10 days (±2 days) and 30 days (±3 days) postoperatively |
| Side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Bispebjerg Hospital | Copenhagen | 2400 | Denmark | |||
| Department of Surgery, Herlev Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32432123 | Derived | Fonnes S, Roepstorff S, Holzknecht BJ, Olesen CS, Olsen JHH, Schmidt L, Alder R, Gamborg S, Rasmussen T, Arpi M, Jorgensen LN, Rosenberg J. Shorter Total Length of Stay After Intraperitoneal Fosfomycin, Metronidazole, and Molgramostim for Complicated Appendicitis: A Pivotal Quasi-Randomized Controlled Trial. Front Surg. 2020 May 5;7:25. doi: 10.3389/fsurg.2020.00025. eCollection 2020. |
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Quasi-randomised controlled trial
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| Standard antibiotics intravenously | Drug | 4 g piperacillin/500 mg tazobactam and 1 g metronidazole administered intravenously during surgery followed by 4 g piperacillin/500 mg tazobactam and 500 mg metronidazole administered intravenously three times daily for three days. |
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Number and description. A questionnaire regarding side effects is collected within the first 24 hours after surgery and at 10 days postoperatively (±2 days) |
| Within 24 hours after surgery and 10 days (±2 days) postoperatively |
| Postoperative complications | Number. According to the Clavien-Dindo grading | From end of surgery until 30-days follow-up |
| Surgical site infections requiring surgical drainage | It is defined as deep incisional surgical site infection according to Centre for Disease Control and Prevention (CDC) | From end of surgery until 30-days follow-up |
| Intraabdominal abscesses requiring drainage | Number. It is defined as an organ/space surgical site infection according to CDC | From end of surgery until 30-days follow-up |
| Readmissions | Number. Only readmissions related to the surgery will be registered; e.g. admission and treatment of a non-related condition will not be registered. | From end of surgery until 30-days follow-up |
| Reoperations | Number. Only reoperations related to the appendectomy will be registered. | From end of surgery until 30-days follow-up |
| Time to return to normal activities | Time period in days. The date is defined at the time point at which the participant could return to normal daily activities. | From end of surgery until 30-days follow-up |
| Period of sick leave "absence from work" | Time periode in days. The parameter is defined as the number of days from the operation to the time point at where the participant returned to work or school. | From end of surgery until 30-days follow-up |
| Costs | The estimated total costs of admission, surgery, possible complications, reoperations etc. in the two treatment groups. | From end of surgery until 30-days follow-up |
| Adverse events | From end of surgery until 30-days follow-up |
| Microbiological flora and susceptibility | Number and type of positive specimens. If participants have a postoperative infectious complication. | From end of surgery until 30-days follow-up |
| Herlev |
| 2730 |
| Denmark |
| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| C082856 | regramostim |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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