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Completed

NCT Number: NCT03435900

Intraperitoneal Administration of Fosfomycin, Metronidazole and Molgramostim Versus Intravenous Antibiotics for Perforated Appendicitis

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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Key information

Conditions

Appendicitis Perforated Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Surgery, Bispebjerg Hospital, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Suspicion of acute appendicitis and planned for diagnostic laparoscopy and eventual laparoscopic appendectomy
  • Perforated appendicitis (diagnosed during surgery by the surgeon)
  • Negative p-HCG (women)
  • Written informed consent after written and verbal information (preoperatively for the intervention group and postoperatively for the control group)

Exclusion criteria

  • Cannot understand, read or speak Danish
  • Previous allergic reaction to fosfomycin, metronidazole, rhGM-CSF, or penicillins e.g. piperacillin or amoxicillin
  • Diagnostic laparoscopy revealing normal appendix not requiring an appendectomy or appendicitis without perforation
  • Other intra-abdominal pathology requiring surgical intervention at the same operation
  • Known renal or hepatic disease or biochemical evidence at the time of admission
  • Known hematologic disease in current medical treatment
  • American Society of Anesthesiologists (ASA) physical status ≥4 (a patient with severe systemic disease that is a constant threat to life)
  • Body weight >110 kg
  • Surgery converted to open appendectomy
  • Anticipated compliance problems

Treatment and study plan

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.

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.

Primary outcomes

  1. Total length of hospital stay

    Time frame: From end of surgery until 30-days follow-up

    in hours

Secondary outcomes

  1. Gastrointestinal Quality of Life Index (GIQLI)

    Time frame: 10 days (±2 days) and 30 days (±3 days) postoperatively

    A disease-specific questionnaire validated in Danish is collected at 10 days postoperatively (±2 days) and at 30 days postoperatively (±3 days)

  2. Side effects

    Time frame: Within 24 hours after surgery and 10 days (±2 days) postoperatively

    Number and description. A questionnaire regarding side effects is collected within the first 24 hours after surgery and at 10 days postoperatively (±2 days)

  3. Postoperative complications

    Time frame: From end of surgery until 30-days follow-up

    Number. According to the Clavien-Dindo grading

  4. Surgical site infections requiring surgical drainage

    Time frame: From end of surgery until 30-days follow-up

    It is defined as deep incisional surgical site infection according to Centre for Disease Control and Prevention (CDC)

  5. Intraabdominal abscesses requiring drainage

    Time frame: From end of surgery until 30-days follow-up

    Number. It is defined as an organ/space surgical site infection according to CDC

  6. Readmissions

    Time frame: From end of surgery until 30-days follow-up

    Number. Only readmissions related to the surgery will be registered; e.g. admission and treatment of a non-related condition will not be registered.

  7. Reoperations

    Time frame: From end of surgery until 30-days follow-up

    Number. Only reoperations related to the appendectomy will be registered.

  8. Time to return to normal activities

    Time frame: From end of surgery until 30-days follow-up

    Time period in days. The date is defined at the time point at which the participant could return to normal daily activities.

  9. Period of sick leave "absence from work"

    Time frame: From end of surgery until 30-days follow-up

    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.

  10. Costs

    Time frame: From end of surgery until 30-days follow-up

    The estimated total costs of admission, surgery, possible complications, reoperations etc. in the two treatment groups.

  11. Adverse events

    Time frame: From end of surgery until 30-days follow-up

  12. Microbiological flora and susceptibility

    Time frame: From end of surgery until 30-days follow-up

    Number and type of positive specimens. If participants have a postoperative infectious complication.

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Bispebjerg Hospital

Registry information

Official study title

Intraperitoneal Administration of Fosfomycin, Metronidazole and Molgramostim Versus Intravenous Conventional Antibiotics for Perforated Appendicitis - a Pivotal Quasi-randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 19, 2018
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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