Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Shorter Total Length of Stay After Intraperitoneal Fosfomycin, Metronidazole, and Molgramostim for Complicated Appendicitis: A Pivotal Quasi-Randomized Controlled Trial

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

APA

CBE

MLA

Vancouver

Author

Bibtex

@article{d419e62715cc4e3b9de32452f9fed87e,
title = "Shorter Total Length of Stay After Intraperitoneal Fosfomycin, Metronidazole, and Molgramostim for Complicated Appendicitis: A Pivotal Quasi-Randomized Controlled Trial",
abstract = "Background: We aimed to investigate the difference in the total length of hospital stay (LOS) after intraperitoneal vs. intravenous antibiotic treatment in patients with complicated appendicitis. Methods: We conducted a quasi-randomized prospective clinical trial. The intervention group received 4 g fosfomycin, 1 g metronidazole, and 50 μg recombinant human granulocyte-macrophage colony-stimulating factor intraperitoneally, which was left in the abdominal cavity, immediately after laparoscopic appendectomy. Postoperatively, this group received antibiotics orally. The control group received intravenous antibiotics both during surgery and postoperatively. We primarily evaluated total LOS within 30 days. Furthermore, we evaluated harms and adverse events, Gastrointestinal Quality of Life Index, postoperative complications, and convalescence. Participants were followed for 30 days postoperatively. Results: A total of 12 participants concluded the trial. The total LOS was significantly shorter in the intervention group (six participants, median 13 h; range 2-21 h) than in the control group (six participants, median 84 h; range 67-169 h), p = 0.017. Comparable harms and Gastrointestinal Quality of Life Index scores were found in the two groups. The time to return to normal activities was median 6 and 10 days for the intervention and the control group, respectively. There were no serious adverse events related to the trial nor any complications in the intervention group. In the control group, two patients developed intraabdominal abscesses. Conclusions: The intervention group had a significantly shorter total LOS. The study was not powered to assess differences in complications, but the results indicate that the intervention seems to be a safe regimen, which can be investigated further to treat patients with complicated appendicitis. Identifiers: EudraCT no. 2017-004753-16. ClinicalTrials: https://clinicaltrials.gov/ct2/show/NCT03435900?term=NCT03435900&draw=2&rank=1{"}>draw=2&rank=1.",
keywords = "appendicitis, clinical trial, intraabdominal infection, perforation, prophylactic antibiotics",
author = "Siv Fonnes and S{\o}ren Roepstorff and Holzknecht, {Barbara Juliane} and Olesen, {Christoffer Skov} and Olsen, {Joachim Hjalde Halmsted} and Line Schmidt and Rasmus Alder and Sara Gamborg and Tilde Rasmussen and Magnus Arpi and J{\o}rgensen, {Lars Nannestad} and Jacob Rosenberg",
note = "Copyright {\textcopyright} 2020 Fonnes, Roepstorff, Holzknecht, Olesen, Olsen, Schmidt, Alder, Gamborg, Rasmussen, Arpi, J{\o}rgensen and Rosenberg.",
year = "2020",
month = may,
day = "5",
doi = "10.3389/fsurg.2020.00025",
language = "English",
volume = "7",
pages = "25",
journal = "Frontiers in Surgery",
issn = "2296-875X",
publisher = "Frontiers Media S.A.",

}

RIS

TY - JOUR

T1 - Shorter Total Length of Stay After Intraperitoneal Fosfomycin, Metronidazole, and Molgramostim for Complicated Appendicitis

T2 - A Pivotal Quasi-Randomized Controlled Trial

AU - Fonnes, Siv

AU - Roepstorff, Søren

AU - Holzknecht, Barbara Juliane

AU - Olesen, Christoffer Skov

AU - Olsen, Joachim Hjalde Halmsted

AU - Schmidt, Line

AU - Alder, Rasmus

AU - Gamborg, Sara

AU - Rasmussen, Tilde

AU - Arpi, Magnus

AU - Jørgensen, Lars Nannestad

AU - Rosenberg, Jacob

N1 - Copyright © 2020 Fonnes, Roepstorff, Holzknecht, Olesen, Olsen, Schmidt, Alder, Gamborg, Rasmussen, Arpi, Jørgensen and Rosenberg.

PY - 2020/5/5

Y1 - 2020/5/5

N2 - Background: We aimed to investigate the difference in the total length of hospital stay (LOS) after intraperitoneal vs. intravenous antibiotic treatment in patients with complicated appendicitis. Methods: We conducted a quasi-randomized prospective clinical trial. The intervention group received 4 g fosfomycin, 1 g metronidazole, and 50 μg recombinant human granulocyte-macrophage colony-stimulating factor intraperitoneally, which was left in the abdominal cavity, immediately after laparoscopic appendectomy. Postoperatively, this group received antibiotics orally. The control group received intravenous antibiotics both during surgery and postoperatively. We primarily evaluated total LOS within 30 days. Furthermore, we evaluated harms and adverse events, Gastrointestinal Quality of Life Index, postoperative complications, and convalescence. Participants were followed for 30 days postoperatively. Results: A total of 12 participants concluded the trial. The total LOS was significantly shorter in the intervention group (six participants, median 13 h; range 2-21 h) than in the control group (six participants, median 84 h; range 67-169 h), p = 0.017. Comparable harms and Gastrointestinal Quality of Life Index scores were found in the two groups. The time to return to normal activities was median 6 and 10 days for the intervention and the control group, respectively. There were no serious adverse events related to the trial nor any complications in the intervention group. In the control group, two patients developed intraabdominal abscesses. Conclusions: The intervention group had a significantly shorter total LOS. The study was not powered to assess differences in complications, but the results indicate that the intervention seems to be a safe regimen, which can be investigated further to treat patients with complicated appendicitis. Identifiers: EudraCT no. 2017-004753-16. ClinicalTrials: https://clinicaltrials.gov/ct2/show/NCT03435900?term=NCT03435900&draw=2&rank=1">draw=2&rank=1.

AB - Background: We aimed to investigate the difference in the total length of hospital stay (LOS) after intraperitoneal vs. intravenous antibiotic treatment in patients with complicated appendicitis. Methods: We conducted a quasi-randomized prospective clinical trial. The intervention group received 4 g fosfomycin, 1 g metronidazole, and 50 μg recombinant human granulocyte-macrophage colony-stimulating factor intraperitoneally, which was left in the abdominal cavity, immediately after laparoscopic appendectomy. Postoperatively, this group received antibiotics orally. The control group received intravenous antibiotics both during surgery and postoperatively. We primarily evaluated total LOS within 30 days. Furthermore, we evaluated harms and adverse events, Gastrointestinal Quality of Life Index, postoperative complications, and convalescence. Participants were followed for 30 days postoperatively. Results: A total of 12 participants concluded the trial. The total LOS was significantly shorter in the intervention group (six participants, median 13 h; range 2-21 h) than in the control group (six participants, median 84 h; range 67-169 h), p = 0.017. Comparable harms and Gastrointestinal Quality of Life Index scores were found in the two groups. The time to return to normal activities was median 6 and 10 days for the intervention and the control group, respectively. There were no serious adverse events related to the trial nor any complications in the intervention group. In the control group, two patients developed intraabdominal abscesses. Conclusions: The intervention group had a significantly shorter total LOS. The study was not powered to assess differences in complications, but the results indicate that the intervention seems to be a safe regimen, which can be investigated further to treat patients with complicated appendicitis. Identifiers: EudraCT no. 2017-004753-16. ClinicalTrials: https://clinicaltrials.gov/ct2/show/NCT03435900?term=NCT03435900&draw=2&rank=1">draw=2&rank=1.

KW - appendicitis

KW - clinical trial

KW - intraabdominal infection

KW - perforation

KW - prophylactic antibiotics

UR - http://www.scopus.com/inward/record.url?scp=85085136073&partnerID=8YFLogxK

U2 - 10.3389/fsurg.2020.00025

DO - 10.3389/fsurg.2020.00025

M3 - Journal article

C2 - 32432123

VL - 7

SP - 25

JO - Frontiers in Surgery

JF - Frontiers in Surgery

SN - 2296-875X

M1 - 25

ER -

ID: 60987907