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The AirSeal System Valve-less Trocar is known to decrease postoperative pain, consumption of analgesics, operating time, and length of stay in adults during robotic and laparoscopic procedures. The investigators would like to know if these allegations also apply to children.
From January the 1st 2022 to December the 31st 2022, 100 children aged under 18 years old had an appendicular peritonitis treated by laparoscopic appendectomy. The pediatric surgeons either used the AirSeal System Valve-less Trocar or the standard insufflation. On one hand, only the surgeon, the anesthetist and the nurses of the operating room knew which type of insufflation was used. On the other hand, the patient, his parents and the nurses in the pediatric department did not know which type of insufflation was used. The participants were divided in two groups: the Airseal group (A) and the standard group (S). In each group, the investigators studied and compared the postoperative pain, the consumption of analgesics, the operating time, and the length of stay for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Airseal group (A) | Patients who underwent a laparoscopic appendectomy using Airseal |
| |
| Standard group (S) | Patients who underwent a laparoscopic appendectomy using standard insufflation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic appendectomy Laparoscopic appendectomy with Airseal or with standard insufflation | Device | Airseal is a constant and low-pressure insufflation device. Standard insufflation is a variable pressure insufflation device. |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of analgesics | Number of medications taken during hospitalization | From the end of surgery to the discharge home, up to 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Length of stay | From the admission to the discharge home, up to 20 days |
| Operating Time | Time to operate the patients |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged between 4 and 17 years old who underwent laparoscopic appendectomy for appendicular peritonitis using the Airseal® or a Standard Insufflation, from 2022/01/1st to 2022/12/31st.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Clermont-Ferrand | Clermont-Ferrand | Auvergne | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24503370 | Background | Hua J, Gong J, Yao L, Zhou B, Song Z. Low-pressure versus standard-pressure pneumoperitoneum for laparoscopic cholecystectomy: a systematic review and meta-analysis. Am J Surg. 2014 Jul;208(1):143-50. doi: 10.1016/j.amjsurg.2013.09.027. Epub 2014 Jan 16. | |
| 21457071 | Background | Rebuck DA, Zhao LC, Helfand BT, Casey JT, Navai N, Perry KT, Nadler RB. Simple modifications in operating room processes to reduce the times and costs associated with robot-assisted laparoscopic radical prostatectomy. J Endourol. 2011 Jun;25(6):955-60. doi: 10.1089/end.2010.0534. Epub 2011 Apr 2. |
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In the name of anonymization we won't share individual participant data
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| From beginning to end of surgery |
| Mean Digital Pain Scale | Digital Pain Scale: minimum is 0 out of 10 (which means no pain) and maximum is 10 out of 10 (which means very painful). Higher scores mean worse outcomes. | Immediately after surgery until discharge home, up to 20 days |
| 30159821 | Background | de'Angelis N, Petrucciani N, Giannandrea G, Brunetti F. The protocol of low-impact laparoscopic cholecystectomy: the combination of mini-laparoscopy and low-pressure pneumoperitoneum. Updates Surg. 2018 Dec;70(4):553-556. doi: 10.1007/s13304-018-0591-8. Epub 2018 Aug 29. |
| ID | Term |
|---|---|
| D010538 | Peritonitis |
| D001064 | Appendicitis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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