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This is a feasibility study that will be performed at the Astrid Lindgren Children´s Hospital, Karolinska University Hospital, Stockholm, Sweden. It will involve 50 patients, randomized to either conservative, non-operative, treatment with antibiotics OR surgery. The study will test an computerized randomization system, the availability of patients willing to participate in the trial and the trial protocol. The investigators will assess the characteristics of the patients who agree to participate in the study and those who do not. The investigators will explore short term outcome and design suitable long term outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Appendectomy | Active Comparator | Standard surgical treatment, appendectomy |
|
| Conservative, non-surgical treatment | Experimental | Non-operative treatment with intravenous and oral antibiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Appendectomy | Procedure | Standard surgical treatment, normally laparoscopic appendectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of symptoms without significant complications | This outcome measure is designed to be similar between the two groups. It is measured in number of participants that fails its designated treatment. Failure of treatment include abscess formation requiring treatment (prolonged antibiotic course or drainage), wound infection requiring intravenous antibiotics, wound dehiscence requiring treatment, prolonged ileus >5 days, length of stay >7 days, recurrent appendicitis, persistance of symptoms leading to surgery and negative appendectomy. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time in hospital | Number of days as inpatients after initiation of allocated treatment, ea. after randomization. | 7 days |
| Time to resolution of symptoms | In hours, to the time where there is no significant pain (VAS not more than 3), no temprature nor any anorexia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan F Svensson, MD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Astrid Lindgren Children´s Hospital | Stockholm | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31800496 | Derived | Patkova B, Svenningsson A, Almstrom M, Eaton S, Wester T, Svensson JF. Nonoperative Treatment Versus Appendectomy for Acute Nonperforated Appendicitis in Children: Five-year Follow Up of a Randomized Controlled Pilot Trial. Ann Surg. 2020 Jun;271(6):1030-1035. doi: 10.1097/SLA.0000000000003646. | |
| 25072441 | Derived |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D001062 | Appendectomy |
| D000077731 | Meropenem |
| D008795 | Metronidazole |
| D019985 | Benchmarking |
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
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| Conservative, non-surgical treatment | Drug | Non-surgical treatment, intravenous and oral antibiotics. Meropenem and Metronidazol will be used as intravenous antibiotics, Ciprofloxacin and Metronidazol will be used as oral antibiotics. |
|
|
| 7 days |
| Abscess formation | As noted either in hospital or during follow up. | 7 days |
| Early complications | Wound infections, wound dehiscence, diarrhea etc. | 7 days |
| Pain | Measured after 12, 24 and 48 hours with the 0-10 Visual Analoge Scale. | 48 hours |
| Svensson JF, Patkova B, Almstrom M, Naji H, Hall NJ, Eaton S, Pierro A, Wester T. Nonoperative treatment with antibiotics versus surgery for acute nonperforated appendicitis in children: a pilot randomized controlled trial. Ann Surg. 2015 Jan;261(1):67-71. doi: 10.1097/SLA.0000000000000835. |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D008330 | Management Audit |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D015397 | Program Evaluation |
| D011787 | Quality of Health Care |
| D011785 | Quality Assurance, Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |