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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002348-26 | EudraCT Number |
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This study evaluates the effects of preoperative delay and antibiotics on perforation rate of appendix while waiting surgery for acute appendicitis. Patients with diagnosed acute appendicitis are randomized into two urgency groups: surgery within 8 hours or surgery within 24 hours. In addition, patients are randomized to either receive antibiotics while waiting or waiting without antibiotics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery within 8 hours, no antibiotics | Active Comparator | Patients are planned for urgent operation, that should be done within 8 hours. Operation can be done during the night time. Patients do not receive antibiotics while waiting surgery. Prophylactic antibiotics are given 0-30 minutes before incision. |
|
| Surgery within 24 hours, no antibiotics | Experimental | Patients are planned for urgent operation, that should be done within 24 hours. Operations are not done during the night time (00:00 - 08:00), unless necessary to avoid delay over 24 hours. Patients do not receive antibiotics while waiting surgery. Prophylactic antibiotics are given 0-30 minutes before incision. |
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| Surgery within 8 hours, antibiotics | Experimental | Patients are planned for urgent operation, that should be done within 8 hours. Antibiotics (cefuroxime 1.5g and metronidazole 500mg every 8 hours) are given while waiting surgery. |
|
| Surgery within 24 hours, antibiotics | Experimental | Patients are planned for urgent operation, that should be done within 24 hours. Operations are not done during the night time (00:00 - 08:00), unless necessary to avoid delay over 24 hours. Antibiotics (cefuroxime 1.5g and metronidazole 500mg every 8 hours) are given while waiting surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotics, cefuroxime and metronidazole | Drug | Patient receives antibiotics while waiting appendectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complicated appendicitis | Surgical finding is complicated appendicitis (AAST Grade III-V) | during surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time of hospital stay | Time in hours from randomization to discharge from hospital | 30 days from surgery |
| Postoperative complications | complications are defined according to Clavien-Dindo classification |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panu J Mentula, MD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HUS, Jorvi Hospital | Espoo | Finland | ||||
| HUS, Meilahti Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24970111 | Background | Sammalkorpi HE, Mentula P, Leppaniemi A. A new adult appendicitis score improves diagnostic accuracy of acute appendicitis--a prospective study. BMC Gastroenterol. 2014 Jun 26;14:114. doi: 10.1186/1471-230X-14-114. | |
| 24553565 | Background | Shafi S, Aboutanos M, Brown CV, Ciesla D, Cohen MJ, Crandall ML, Inaba K, Miller PR, Mowery NT; American Association for the Surgery of Trauma Committee on Patient Assessment and Outcomes. Measuring anatomic severity of disease in emergency general surgery. J Trauma Acute Care Surg. 2014 Mar;76(3):884-7. doi: 10.1097/TA.0b013e3182aafdba. |
| Label | URL |
|---|---|
| Link for calculation of Adult Appendicitis Score | View source |
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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 |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D002444 | Cefuroxime |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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Patients are randomized into two arms according to urgency and simultaneously each patient is randomized into two arms according to antibiotic treatment
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| No antibiotics | Drug | No antibiotics are given while waiting surgery. |
|
| urgent schedule | Other | Patients can wait up to 8 hours for surgery. |
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| less urgent schedule | Other | Patients can wait up to 24 hours for surgery. |
|
| 30 days from surgery |
| Pain measured by numeric rating scale while waiting surgery | Pain is measured by numeric rating scale (NRS) every hour by patient, and area under NRS represents overall pain. | up to 36 hours |
| Surgical site infections (SSI) and positive blood cultures | SSIs classified according to CDC classification: superficial incisional, deep incisional and organ/space infection. Blood cultures are obtained if patient has fever over 38.5 degrees Celcius. | within 30 days from randomization |
| Conversions of laparoscopic surgeries to open surgery | All surgeries are started as laparoscopic surgery. Conversion means that operation is converted to open surgery during the same operation. | during the the first operation for acute appendicitis |
| Gangrenous or perforated appendicitis according to pathological examination. | All specimens are sent to pathological examination and all pathological reports are reviewed | 3 week after surgery |
| Sunshine Appendicitis Grading System Score classification | Sunshine Appendicitis Grading System Score (range 0-4) for appendicitis. Higher score represents worse outcome | during surgery |
| Helsinki |
| 00029 |
| Finland |
| 26333132 | Background | Reid F, Choi J, Williams M, Chan S. Prospective evaluation of the Sunshine Appendicitis Grading System score. ANZ J Surg. 2017 May;87(5):368-371. doi: 10.1111/ans.13271. Epub 2015 Sep 1. |
| 37717589 | Derived | Jalava K, Sallinen V, Lampela H, Malmi H, Steinholt I, Augestad KM, Leppaniemi A, Mentula P. Role of preoperative in-hospital delay on appendiceal perforation while awaiting appendicectomy (PERFECT): a Nordic, pragmatic, open-label, multicentre, non-inferiority, randomised controlled trial. Lancet. 2023 Oct 28;402(10412):1552-1561. doi: 10.1016/S0140-6736(23)01311-9. Epub 2023 Sep 14. |
| 34580704 | Derived | Jalava K, Sallinen V, Lampela H, Malmi H, Leppaniemi A, Mentula P. Role of delay and antibiotics on PERForation rate while waiting appendicECTomy (PERFECT): a protocol for a randomized non-inferiority trial. BJS Open. 2021 Sep 6;5(5):zrab089. doi: 10.1093/bjsopen/zrab089. |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D002511 |
| Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| 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 |