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Study terminated early
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| Name | Class |
|---|---|
| Mount Sinai Hospital, New York | OTHER |
| NYU Langone Health | OTHER |
| Weill Medical College of Cornell University | OTHER |
| Columbia University |
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The objective of this study is to determine whether the use of postoperative antibiotics following endoscopic sinus surgery (ESS) decreases postoperative infection rates. This is a multi-institutional prospective study involving Albert Einstein College of Medicine/Montefiore Medical Center, Columbia University Medical Center, Weill Cornell Medical College, Mount Sinai Health System, and New York University Langone Medical Center. The study design will be a multi-institutional prospective randomized controlled trial with parallel random groups assigned to receive postoperative antibiotics or no postoperative antibiotics. The investigators hypothesize that patients who receive postoperative antibiotics will have lower postoperative infection rates and improved postoperative sinonasal symptoms and nasal endoscopy scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotics | Experimental | To receive postoperative antibiotics |
|
| No antibiotics | No Intervention | Will not receive any postoperative antibiotics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxi Clavulanate | Drug | Postoperative antibiotics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Infection | The number/percentage of participants with postoperative infection rate, as assessed by rigid nasal endoscopy in the office and culture of suspected infectious material noted within the paranasal sinuses will be reported. A postoperative infection as defined by having an infection at ANY of the postoperative visits AND detected initially by evidence of purulence on nasal endoscopy will be considered an infection if the culture swab from the site of purulence during that office visit confirms that there is an actual bacterial source of the infection. | During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Sino-nasal Outcome Test (SNOT-22) Scores | Postoperative SNOT-22 scores will be summarized for each visit based on patient-reported symptoms. The SNOT-22 is a 22-item questionnaire used to assess the impact of chronic rhinosinusitis (CRS) on a patient's health-related quality of life. Participants are presented with a list of symptoms and social/emotional consequences of rhinosinusitis and asked to rate each problem over the prior 2-week period on a 6-point Likert scale ranging from 0 ("No Problem") to 5 ("Problem as bad as it can be)" yielding an overall possible scoring range of 0-110. Higher scores are indicative of a greater burden CRS-related symptoms. Scores are summarized by study arm using basic descriptive statistics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadeem Akbar, MD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Antibiotics | To receive postoperative antibiotics Amoxi Clavulanate: Postoperative antibiotics |
| FG001 | No Antibiotics | Will not receive any postoperative antibiotics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Antibiotics | To receive postoperative antibiotics Amoxi Clavulanate: Postoperative antibiotics |
| BG001 | No Antibiotics | Will not receive any postoperative antibiotics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postoperative Infection | The number/percentage of participants with postoperative infection rate, as assessed by rigid nasal endoscopy in the office and culture of suspected infectious material noted within the paranasal sinuses will be reported. A postoperative infection as defined by having an infection at ANY of the postoperative visits AND detected initially by evidence of purulence on nasal endoscopy will be considered an infection if the culture swab from the site of purulence during that office visit confirms that there is an actual bacterial source of the infection. | Posted | Count of Participants | Participants | During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively |
|
Up to 8 weeks following endoscopic sinus surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Antibiotics | To receive postoperative antibiotics Amoxi Clavulanate: Postoperative antibiotics |
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We had a very low enrollment and therefore were unable to reach any statistical significance with any of our endpoints.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadeem Akbar MD | Montefiore Medical Center | 7189204646 | nakbar@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2018 | May 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
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| OTHER |
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| During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively |
| Perioperative Sinus Endoscopy (POSE) Scores | Sinonasal crusting and inflammation was determined using the perioperative sinus endoscopy (POSE) scoring system based on patient-reported symptoms obtained during all three study visits. POSE assigns points to various areas within the nasal passages, based on the presence of certain conditions like crusting, edema, polyps, secretions, etc. For purposes of this study each parameter was scored from 0-2 yielding an overall possible score of 0-10, with higher scores being indicative of more extensive disease severity or surgical extent in the sinuses. Scores are summarized by study arm using basic descriptive statistics. | During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Active Infection at time of surgery | The number of participants with an active infection at the time of surgery is summarized by study arm. | Count of Participants | Participants |
|
| OG001 |
| No Antibiotics |
Will not receive any postoperative antibiotics |
|
|
| Secondary | Postoperative Sino-nasal Outcome Test (SNOT-22) Scores | Postoperative SNOT-22 scores will be summarized for each visit based on patient-reported symptoms. The SNOT-22 is a 22-item questionnaire used to assess the impact of chronic rhinosinusitis (CRS) on a patient's health-related quality of life. Participants are presented with a list of symptoms and social/emotional consequences of rhinosinusitis and asked to rate each problem over the prior 2-week period on a 6-point Likert scale ranging from 0 ("No Problem") to 5 ("Problem as bad as it can be)" yielding an overall possible scoring range of 0-110. Higher scores are indicative of a greater burden CRS-related symptoms. Scores are summarized by study arm using basic descriptive statistics. | The numbers reflect loss of follow up of patients during successive visits. | Posted | Mean | Standard Deviation | score on a scale | During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively |
|
|
|
| Secondary | Perioperative Sinus Endoscopy (POSE) Scores | Sinonasal crusting and inflammation was determined using the perioperative sinus endoscopy (POSE) scoring system based on patient-reported symptoms obtained during all three study visits. POSE assigns points to various areas within the nasal passages, based on the presence of certain conditions like crusting, edema, polyps, secretions, etc. For purposes of this study each parameter was scored from 0-2 yielding an overall possible score of 0-10, with higher scores being indicative of more extensive disease severity or surgical extent in the sinuses. Scores are summarized by study arm using basic descriptive statistics. | The numbers reflect loss of follow up of patients during successive visits. | Posted | Mean | Standard Deviation | score on a scale | During all three scheduled postoperative visits: 7-10 days postoperatively; 2-4 weeks postoperatively; 6-8 weeks postoperatively |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | No Antibiotics | Will not receive any postoperative antibiotics | 0 | 12 | 0 | 12 | 0 | 12 |
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| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| 2 to 4 weeks post op |
|
|
| 6 to 8 weeks post op |
|
|
| 2 to 4 weeks post op |
|
|
| 6 to 8 weeks post op |
|
|