Trial · NCT03688295
The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis)
NCT03688295, Phase 3, Unknown, Centre Hospitalier Universitaire, Amiens
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis). Trials, record NCT03688295. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03688295
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Value of Post-operative Antibiotic Therapy After Laparoscopic Appendectomy for Complicated Acute Appendicitis (Other Than for Generalized Peritonitis)
- NCT number
- NCT03688295
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 1,476 participants, estimated
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Conditions
- Complicated Acute Appendicitis
- Interventions
- No antibiotics, Antibiotics
- First posted
- 2018-09-28
- Last updated
- 2023-05-17
- Other registries' IDs
- eudract:2017-000334-59
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | proportion of patients having developed organ space surgical site infections (SSIs) by postoperative day (POD)30 | postoperative day 30 | primary outcome is the proportion of patients with deep SSIs by POD30. Deep SSIs are officially defined by the CDCcentre of disease control and prevention (CDC) as infections that occur within 30 days of surgery AND appear to be related to the surgery AND affect the organ or the cavity around the surgical site (i.e. any anatomical structure - other than the incision - that is opened or handled during surgery) AND for which at least one of the following signs is observed: pus coming from a drain placed in the organ or cavity; germs isolated from a liquid or tissue sample collected aseptically from the organ or cavity; an abscess or another obvious sign of infection of the organ or cavity found by macroscopic examination during subsequent surgery or in a radiological or histopathological examination. |
| Secondary | Quality of life post surgery using the 36-Item Short Form Health Survey | day 0 and day 30 | Quality of life on day 0 and day 30 post surgery, with the 36-Item Short Form Health Survey questionnaires (0 = very bad, 100 = very good) |
| Secondary | proportion of patients with superficial SSIs | postoperative day 30 | The proportion of patients with superficial SSIs, defined as infections that occur within 30 days of the intervention AND affect the skin and subcutaneous tissue AND or which at least one of the following signs is observed: pus coming from the superficial part of the incision, germs isolated from a liquid or tissue sample collected aseptically from the superficial part of the incision, a sign of infection (pain, tenderness, redness, burning, etc.) associated with deliberate opening of the superficial part of the incision by the surgeon (except if the culture is negative). Infection of the superficial part of the incision is diagnosed by the surgeon (or the physician attending to the patient). |
| Secondary | post-operative infection rates | postoperative day 30 | post-operative infection rates by POD30, including SSIs and remote infections. |
| Secondary | number of antibiotic-free days | postoperative day 30 | number of antibiotic-free days between randomization and POD30 |
| Secondary | Description of the microbial flora | Day 0 | Description of the microbial flora found in the antibiogram of the per-operative sample collected in all cases |
| Secondary | balance between antibiotic therapy and microbial resistance | postoperative day 30 | balance between antibiotic therapy and microbial resistance |
| Secondary | Evaluation of morbidity and mortality | postoperative day 30 | Evaluation of morbidity and mortality (according to the Dindo-Clavien classification and the Comprehensive Complication Index (CCI)). |
| Secondary | Length of hospital stay | postoperative day 30 | Length of hospital stay, defined as the number of days of hospitalization between surgery and discharge |
| Secondary | rehospitalization rate | postoperative day 30 | rehospitalization rate, defined as the proportion of patients rehospitalized during the study |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32487213 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03688295
GET https://conductscience.org/api/trials/v1/NCT03688295/registered