Trial · NCT03159754
Optimal Care of Complicated Appendicitis
NCT03159754, Phase 4, Completed, University of Michigan; results first posted 2023-11-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Optimal Care of Complicated Appendicitis. Trials, record NCT03159754. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03159754
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimal Care of Complicated Appendicitis
- NCT number
- NCT03159754
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 40 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Appendicitis, Perforated Appendicitis, Ruptured Appendicitis, Complicated Appendicitis
- Interventions
- Early Appendectomy, Interval Appendectomy, Antibiotics
- First posted
- 2017-05-19
- Last updated
- 2023-11-28
- Results first posted
- 2023-11-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Cost of Care | The original intention was to gather cost data for 2 years per person following admission. As no cost data was able to be procured, there is no time frame to which it applies. | Total health care cost starting from time of admission was the intention of this outcome measure. However, the institutions potentially involved were unwilling to provide access to any cost data so this could not be analyzed for any length of time. |
| Secondary | Complications | During index/initial hospitalization (generally not more than 5-6 weeks) | Number of persons who experience any of a number of specified complications, including new/recurrent abscess, wound infection, small bowel obstruction, or need for a larger operation |
| Secondary | Parents Away From Work | During index/initial hospitalization (generally not more than 5-6 weeks) | Parents away from work measured in days is presented here. The intention was to collect "missed activity days" for children as well as missed parent work days. However, the question to capture this information referred to school and was determined to be too inconsistent with the way the question may have been interpreted when the survey was given to code reliably. |
| Secondary | Duration of Antibiotic Therapy | During index/initial hospitalization (generally not more than 5-6 weeks) | Duration of antibiotic therapy measured in days |
| Secondary | Length of Stay | During index/initial hospitalization (generally not more than 5-6 weeks) | Length of all hospital stays measured in days |
| Secondary | Number of Percutaneous Drainage Procedures | During index/initial hospitalization (generally not more than 5-6 weeks) | Number of persons with differing numbers of percutaneous drainage procedures |
| Secondary | Number of Radiographic Imaging Studies | During index/initial hospitalization (generally not more than 5-6 weeks) | Number of radiographic imaging studies including ultrasound, CT, and MRI |
| Secondary | Quality of Life (PedsQL) | 1 month; for GI QOL; 2 years for Peds QL | Original QOL outcome measure listed was: Quality of life measured by PedsQL 2 years following discharge. Two year data collected was insufficient to allow for any analysis. One month GI QOL data collected, also listed in the protocol, is shown below. GI QoL is a validated measure with scores ranging from 0 to 100, where lower scores mean worse quality of life and higher scores mean better quality of life. Peds QL is a validated measure with scores ranging from 0 to 100, where lower scores mean worse quality of life and higher scores mean better quality of life. |
| Secondary | Recurrent Appendicitis | 2 years; (Although this appears longer than trial duration, study completion date is based on last 2 year survey turned in, and medical record analysis looked a full two years per participant which extended a bit longer.) | Number of persons who experience recurrent appendicitis requiring hospitalization. Because the early appendectomy arm participant by definition have no appendix to infect after surgery, they are not shown below. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Cost of Care | The original intention was to gather cost data for 2 years per person following admission. As no cost data was able to be procured, there is no time frame to which it applies. | No cost data for any participants was able to be procured. Thus this outcome could not be achieved or analyzed in any fashion. | ||
| SECONDARY | Complications | During index/initial hospitalization (generally not more than 5-6 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Parents Away From Work | During index/initial hospitalization (generally not more than 5-6 weeks) | Data shown is all that is available - multiple individuals' data is not available. | days | MEAN |
| SECONDARY | Duration of Antibiotic Therapy | During index/initial hospitalization (generally not more than 5-6 weeks) | One person's data from the early appendectomy and four persons from the interval appendectomy for this outcome measure is unavailable. | days | MEAN |
| SECONDARY | Length of Stay | During index/initial hospitalization (generally not more than 5-6 weeks) | days | MEAN | |
| SECONDARY | Number of Percutaneous Drainage Procedures | During index/initial hospitalization (generally not more than 5-6 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Radiographic Imaging Studies | During index/initial hospitalization (generally not more than 5-6 weeks) | number of imaging procedures/participant | MEAN | |
| SECONDARY | Quality of Life (PedsQL) | 1 month; for GI QOL; 2 years for Peds QL | population sizes listed represent the full number of surveys collected for 1 month GI QOL; For 2 year Peds QL, only one participant provided data for the Interval and No Appendectomy arms, so it is not shown to preserve confidentiality; similarly for early appendectomy, there was only 1 child (as opposed to teens) who completed the survey, so it is not included either. | score on a scale | MEAN |
| SECONDARY | Recurrent Appendicitis | 2 years; (Although this appears longer than trial duration, study completion date is based on last 2 year survey turned in, and medical record analysis looked a full two years per participant which extended a bit longer.) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complications | Early Appendectomy | 9 | Participants | ||
| Complications | Interval Appendectomy | 6 | Participants | ||
| Complications | No Appendectomy | 1 | Participants | ||
| Parents Away From Work | Early Appendectomy | 7.6 | Full Range 1 to 21 | days | |
| Parents Away From Work | Interval Appendectomy | 9.3 | Full Range 1 to 16 | days | |
| Parents Away From Work | No Appendectomy | 3.5 | Full Range 3 to 4 | days | |
| Duration of Antibiotic Therapy | Early Appendectomy | 6.3 | Full Range 5 to 17 | days | |
| Duration of Antibiotic Therapy | Interval Appendectomy | 5.1 | Full Range 2 to 6 | days | |
| Duration of Antibiotic Therapy | No Appendectomy | 5.4 | Full Range 5 to 10 | days | |
| Length of Stay | Early Appendectomy | 7.8 | Full Range 0 to 26 | days |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Early Appendectomy | 24 | |
| Overall Study | STARTED | Interval Appendectomy | 12 | |
| Overall Study | STARTED | No Appendectomy | 4 | |
| Overall Study | COMPLETED | Early Appendectomy | 23 | |
| Overall Study | COMPLETED | Interval Appendectomy | 12 | |
| Overall Study | COMPLETED | No Appendectomy | 4 | |
| Overall Study | NOT COMPLETED | Early Appendectomy | 1 | |
| Overall Study | NOT COMPLETED | Interval Appendectomy | 0 | |
| Overall Study | NOT COMPLETED | No Appendectomy | 0 |
Source ClinicalTrials.gov
Adverse events42
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abscess and Drain Placement | Surgical and medical procedures | Early Appendectomy | 4 | 24 | |
| other | Abscess and Drain Placement | Surgical and medical procedures | Interval Appendectomy | 4 | 12 | |
| other | Abscess and Drain Placement | Surgical and medical procedures | No Appendectomy | 1 | 4 | |
| other | Abscess | Infections and infestations | Early Appendectomy | 0 | 24 | |
| other | Abscess | Infections and infestations | Interval Appendectomy | 1 | 12 | |
| other | Abscess | Infections and infestations | No Appendectomy | 0 | 4 | |
| other | Drain Placement | Surgical and medical procedures | Early Appendectomy | 3 | 24 | |
| other | Drain Placement | Surgical and medical procedures | Interval Appendectomy | 0 | 12 | |
| other | Drain Placement | Surgical and medical procedures | No Appendectomy | 0 | 4 | |
| other | Nausea and vomiting | Gastrointestinal disorders | Early Appendectomy | 2 | 24 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Early Appendectomy | 0 | 24 |
| Total, all-cause mortality | Interval Appendectomy | 0 | 12 |
| Total, all-cause mortality | No Appendectomy | 0 | 4 |
| Total, other adverse events | Early Appendectomy | 10 | 24 |
| Total, other adverse events | Interval Appendectomy | 5 | 12 |
| Total, other adverse events | No Appendectomy | 2 | 4 |
| Total, serious adverse events | Early Appendectomy | 3 | 24 |
| Total, serious adverse events | Interval Appendectomy | 2 | 12 |
| Total, serious adverse events | No Appendectomy | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Interval Appendectomy vs No Appendectomy: Recurrent Appendicitis |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03159754
GET https://conductscience.org/api/trials/v1/NCT03159754/results?page=2