Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01697059 · ClinicalTrials.gov registry record · NA

Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis

A NA study of Acute Appendicitis, sponsored by Rhode Island Hospital.

Completed
Registry status
NA
Development phase
73
Enrollment target
1
Study location

NCT01697059: Completed NA study of Acute Appendicitis, sponsored by Rhode Island Hospital.

NCT01697059 is a NA study of Acute Appendicitis that has completed, run by Rhode Island Hospital. The registered enrollment target is 73 participants, below the 875-participant average among 4 other Acute Appendicitis trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01697059, a NA study of Acute Appendicitis, has completed, sponsored by Rhode Island Hospital.

COMPLETED
Registry status
NA
Development phase
73 participants
Enrollment target
1
Study location

Study Summary

Several recent studies have examined the feasibility and benefits of nonoperative treatment of perforated appendicitis in children. One such study showed a trend toward longer operative times for patients randomized to immediate appendectomy, but no overall advantage. In another larger study, the costs of delayed appendectomy for perforated appendicitis were higher - in part related to readmissions in the interval (6-8 weeks). Nevertheless, these and other studies have demonstrated the safety of delaying appendectomy for perforated appendicitis. Emergency appendectomy is a well-established approach, and postoperative recovery in children is fast. Nevertheless, from the onset of symptoms through the hospital stay and the postoperative recovery, appendicitis causes a disruption of a family's normal routine (absence from school and work) of up to 1-2 weeks. Because this is an unplanned operation, patients have to wait until an operating room becomes available, or elective operations have to be placed on hold to accommodate the emergency operation. Each year, more than 250 children undergo an appendectomy at HCH. This represents 250 episodes of emergency surgery, or about one emergency add-on operation per working day. If an initial trial of antibiotics is safe for the treatment of appendicitis, converting an emergency operation into an elective, scheduled outpatient procedure may reduce stress and disruption of routine for patients and their families - and may allow better operating room planning for health care professionals and hospitals. The investigators hypothesize that initial antibiotic treatment of acute (non-perforated) appendicitis, followed by scheduled outpatient appendectomy, reduces the overall cost of treating the disease and results in greater patient and family satisfaction. This pilot study aims to establish the safety and feasibility of treating acute appendicitis with intravenous antibiotics, followed by outpatient oral antibiotics. Patients and

Primary Outcome

If after a period of at least 8 hours (and 2 doses of intravenous antibiotics), the patient's symptoms worsen, or fail to subside within 18 hours, the patient will undergo an emergent/urgent appendectomy, and treatment will proceed as per standard-of-care (1 intraoperative dose of antibiotics, with or without postoperative antibiotics, progressive postoperative diet and discharge home once tolerating a regular diet). The patient will then be considered having failed nonoperative treatment.

Conditions Studied

Interventions

  • DRUG Piperacillin + Amoxicillin

Study Locations (1)

Rhode Island

  • Hasbro Children's Hospital (Rhode Island Hospital) - Providence

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2012-09
Est. Completion 2015-05
Phase NA
Rhode Island Hospital

130 total trials

What the finished NCT01697059 record still lists

NCT01697059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 875-participant average among 4 other Acute Appendicitis trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Acute Appendicitis appearing as the primary indexed condition, and to 1 intervention - of which Piperacillin + Amoxicillin is the first listed.

NCT01697059 reports a single indexed study location in Rhode Island.

Frequently Asked Questions

What is clinical trial NCT01697059 about?

NCT01697059 is a clinical study titled "Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis". Several recent studies have examined the feasibility and benefits of nonoperative treatment of perforated appendicitis in children. One such study showed a trend toward longer operative times for patients randomized to immediate appendectomy, but no overall advantage. In another larger study, the co...

What is the current status of trial NCT01697059?

This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2012-09. Estimated completion is 2015-05.

What conditions does trial NCT01697059 study?

This clinical trial studies the following conditions: Acute Appendicitis.

What interventions are being tested in trial NCT01697059?

The interventions under investigation include: Piperacillin + Amoxicillin (DRUG).

Who is sponsoring clinical trial NCT01697059?

This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01697059 being conducted?

This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Acute Appendicitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT03661307 · 73 participants · Phase 1

    Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

  • NCT05386108 · 73 participants · Phase 1

    Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer

  • NCT05961592 · 73 participants · Phase 1

    R-2487 in Patients With Rheumatoid Arthritis

  • NCT06150664 · 73 participants · Phase 1

    A Phase 1 of CTX-8371 in Patients With Advanced Malignancies

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01697059, the US trial registry maintained by the National Library of Medicine. NCT01697059 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.