An observational study in Perioperative/Postoperative Complications and Drug-Induced Anaphylaxis, sponsored by Assiut University. Completed at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by Assiut University · Observational
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Among 10 studies in Postoperative Complications by Assiut University — 5 open to participants now, 5 under way, none of them phase 3. Postoperative Complications · Assiut University.
Among the 10 studies in Postoperative Complications by Assiut University, this one is the only one that started in 2018, is one of 4 observational ones, and was the 2nd registered.
1,335 studies on the registry are indexed under Postoperative Complications; 310 are open to participants now.
Browse Postoperative Complications studies →5 of the 10 studies in Postoperative Complications by Assiut University are open now, in 1 country. Recruiting first, the newest first:
Assiut University · Sites in Egypt
Ages 40+
Assiut University
Ages 18–40
Assiut University
Ages 18+
Assiut University
Ages 18+
Assiut University · Sites in Egypt
Ages 1 days–18 yrs
By country, each count listing its studies:
Of the 201 Postoperative Complications studies recruiting now, 125 (62%) set no upper age limit and 32 (16%) stop at 75 or younger; 25 take children under 18; 25 take healthy volunteers.
This study: all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 480 is above the median of 251 across 538 observational studies indexed under Postoperative Complications.
Median enrollment 90 across the 6 interventional studies, 42 across the 4 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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Assiut University is the lead sponsor of 5,081 studies on the registry; 2,179 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
5 of the studies in Postoperative Complications by Assiut University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07884006Assiut UniversityImpact of Nutritional Status Before Joint Replacement on Infection Risk | 2026-12-01 |
| NCT07547826Assiut UniversityEfficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies | 2027-05 |
| NCT07797868Assiut UniversityVacuum-Assisted Closure Versus Graduated Primary Skin Closure for Postoperative Burst Abdomen | 2027-10 |
| NCT07892586Assiut UniversityLow-Dose Norepinephrine With Conservative Fluid Therapy in Hepatobiliary Surgery | 2027-10-20 |
| NCT07918495Assiut UniversityEffect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy | 2027-11 |
Add all 5 to your calendar (.ics) → With an account.
Among the 10 studies in Postoperative Complications by Assiut University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Perioperative anaphylaxis is associated with significant morbidity and mortality. Most textbooks describe it as a rare event of the order of 1 in 10 to 1 in 20,000 general anaesthetic cases. However, a recent study in the United Kingdom suggested that 1 in 350 cases have features suspicious of perioperative anaphylaxis. This study suggests that perioperative anaphylaxis may be under recognised and under reported.
When perioperative anaphylaxis is recognised, it would be ideal to carry out investigations firstly to confirm the diagnosis of anaphylaxis and secondly to identify the causative agent. The latter can be difficult in the context of anaesthesia where the patient is exposed to several drugs and other reagents in a short space of time.
One of the interesting aspects of perioperative anaphylaxis is that there is variability in its epidemiology between different countries, for example between the United Kingdom, France, Scandinavia and Australia and New Zealand. There are currently no data from Egypt to include in such comparisons and to inform clinical practice.
As well as being at risk if a drug allergen is not identified, patients can also be at risk from an incorrect allergy label. The most common example of this is penicillin allergy where fewer than 10% of patients with a history of penicillin allergy are found to be allergic. Incorrect penicillin allergy labels are potentially harmful for patients attending for surgery because the label independently increases the risk of developing infection to resistant organisms, longer hospital stays and mortality.
Perioperative anaphylaxis is associated with significant morbidity and mortality. Most textbooks describe it as a rare event of the order of 1 in 10 to 1 in 20,000 general anaesthetic cases. However, a recent study in the United Kingdom suggested that 1 in 350 cases have features suspicious of perioperative anaphylaxis. This study suggests that perioperative anaphylaxis may be under recognised and under reported.
When perioperative anaphylaxis is recognised, it would be ideal to carry out investigations firstly to confirm the diagnosis of anaphylaxis and secondly to identify the causative agent. The latter can be difficult in the context of anaesthesia where the patient is exposed to several drugs and other reagents in a short space of time.
One of the interesting aspects of perioperative anaphylaxis is that there is variability in its epidemiology between different countries, for example between the United Kingdom, France, Scandinavia and Australia and New Zealand. There are currently no data from Egypt to include in such comparisons and to inform clinical practice.
As well as being at risk if a drug allergen is not identified, patients can also be at risk from an incorrect allergy label. The most common example of this is penicillin allergy where fewer than 10% of patients with a history of penicillin allergy are found to be allergic. Incorrect penicillin allergy labels are potentially harmful for patients attending for surgery because the label independently increases the risk of developing infection to resistant organisms, longer hospital stays and mortality.
Aim of the work:
This project proposes the following studies:
Patient and Methods:
This study will be conducted in Assiut University Hospitals. A blood cell sample for mast cell tryptase will be taken immediately prior to surgery and 1 hour following induction of anaesthesia in the following groups of patients (n = 30 in each case):
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A blood cell sample for mast cell tryptase will be taken immediately prior to surgery and 1 hour following induction of anaesthesia in the following groups of patients (n = 30 in each case):
(a) Children undergoing elective surgery between the ages of 3 and 10 years (b) Adults between the ages of 16 and 30 years undergoing orthopaedic trauma surgery (c) Adults more than 60 years of age undergoing orthopaedic surgery (d) Women of any age undergoing gynaecological surgery (e) Adults of any age undergoing emergency general surgery (g) Women undergoing caesarean section under general or regional anaesthesia
Exclusion criteria:
patient refusal, history of previous allergic reaction.
Data will be collected on 1000 consecutive general anaesthetic procedures in Assiut University Hospitals. After each elective operating list the anaesthetist will be asked to complete a form in which they will document the number of patients receiving general anaesthesia on the list and the number of those patients who developed any of the following features: unexpected, unexplained hypotension; unexpected bronchospasm resistant to treatment; angioedema; urticaria; severe itching; widespread erythema
Incidence of suspected perioperative anaphylaxis in an Egyptian population.
Snap shot on epidemiology of perioperative hypersensitivity reactions in an Egyptian population
Time frame: one year
Effect of anaesthesia and surgery on mast cell tryptase
Study effect of age, sex, anaesthesia, fluid and surgery on mast cell tryptase in control and reaction groups
Time frame: two years
Ran from Jan 2018 to primary completion in Dec 2022, 59 months.
Of 276 non-industry observational studies under Postoperative Complications, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's 59 months is above that.
Counting every sponsor, half of 281 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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