Acute AbdomenNCT05591495
The Role of Laparoscopy in Upper Abdominal Surgical Emergencies in Adults: A Retrospective Observational Study.
An observational study of Acute Abdomen, run by Zagazig University.
Trial summary
Introduction Laparoscopy can be used to diagnose and treat the etiologies of acute abdominal pain. This study aimed to assess laparoscopy's effectiveness in upper gastrointestinal (G.I.T) emergencies regarding intra-and postoperative outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Abdomen
- What is being tested?
- laparoscopy in upper abdominal surgical emergencies in adults
- Type of treatment
- Surgery or procedure
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jun 2022
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Between June 2017 and June 2020, 215 patients were admitted to Zagazig University Hospital's emergency surgical unit with clinical diagnoses of upper G.I.T. emergencies, namely acute cholecystitis, perforated P.U., acute necrotizing pancreatitis, and splenic trauma. The work has been reported following STROBE guidelines. To be included in the study, patients must meet the following criteria: >18 years of both sexes complaining of acute upper G.I.T. emergencies and undergoing laparoscopic surgeries, namely acute cholecystitis, perforated peptic ulcer, pancreatic necrosis, and splenic injuries. < 18 years of age and open surgeries for upper G.I.T. emergency surgeries were excluded.
Who may be able to join
- clinical diagnoses of upper G.I.T. emergencies, namely acute cholecystitis, perforated P.U., acute necrotizing pancreatitis, and splenic trauma.
Who cannot join
- < 18 years of age and
- open surgeries for upper G.I.T.
About this study
Introduction Laparoscopy can be used to diagnose and treat the etiologies of acute abdominal pain. This study aimed to assess laparoscopy's effectiveness in upper gastrointestinal (G.I.T) emergencies regarding intra-and postoperative outcomes.
Method: A retrospective observational study was conducted in the emergency departments of Zagazig University on 215 patients who had upper abdominal emergency surgeries between June 2017 and June 2020.
Read the detailed description
When surgical procedures are standardized, laparoscopy's benefits in a range of emergency scenarios are without question acknowledged. When only a basic strategy is set for the surgery, and the surgical approach entirely depends on intra-abdominal findings, the benefits are diminished or unknown. The evidence unequivocally supports the superiority of a laparoscopic approach in numerous emergency cases, such as acute cholecystitis, gastroduodenal perforated ulcers, infected pancreatic necrosis, and splenic injuries Laparoscopy gives the primary advantages of a shorter hospital stay, a quicker procedure, and faster recovery without complications. Rapid recovery is connected with early enteral feeding. Adequate nutritional support aids in maintaining homeostasis and, as a result, enhances immunity, thereby decreasing the incidence of wound infection. Laparoscopy should be considered with caution whenever abdominal access is considered difficult, as in cases of organ enlargement, adhesion, and bowel distension. In actuality, creating the pneumoperitoneum is an essential step in the procedure. Increased intraperitoneal pressure produces cardio-respiratory and neurological effects.
In this study, the investigators designed a retrospective observational study to present our experience in assessing the outcomes of a laparoscopic approach in emergent upper abdominal surgery in terms of intraoperative and postoperative complications.
- Conditions
- Acute Abdomen
- Being tested
- laparoscopy in upper abdominal surgical emergencies in adults
- Keywords
- Emergency surgery; Laparoscopy; Upper abdominal surgery
- Medical subject headings
- Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopy in upper abdominal surgical emergencies in adultsProcedure or surgery
evaluation the role of laparoscopy in upper GIT emergencies in adults
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative complications requiring conversion
the number of patients converted to open approach
Measured: 2 years
Secondary outcomes (1)
postoperative complications requiring reintervention
reintervention
Measured: within 2 years of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start1 Jan 2017
- Primary completion1 Jun 2020
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AbdomenStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tamer.A.A.M.Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591495
- Sponsor's protocol ID
- zagazig university 12
- Status last verified
- Oct 2022
- First submitted
- 7 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Laparoscopy in Upper Abdominal Surgical Emergencies in Adults: A Retrospective Observational Study.
- ClinicalTrials.gov ID
- NCT05591495
- Acronym / sponsor ID
- zagazig university 12
- Conditions
- Acute Abdomen
- Keywords
- Emergency surgery; Laparoscopy; Upper abdominal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction Laparoscopy can be used to diagnose and treat the etiologies of acute abdominal pain. This study aimed to assess laparoscopy's effectiveness in upper gastrointestinal (G.I.T) emergencies regarding intra-and postoperative outcomes.
Method: A retrospective observational study was conducted in the emergency departments of Zagazig University on 215 patients who had upper abdominal emergency surgeries between June 2017 and June 2020.
Detailed description
When surgical procedures are standardized, laparoscopy's benefits in a range of emergency scenarios are without question acknowledged. When only a basic strategy is set for the surgery, and the surgical approach entirely depends on intra-abdominal findings, the benefits are diminished or unknown. The evidence unequivocally supports the superiority of a laparoscopic approach in numerous emergency cases, such as acute cholecystitis, gastroduodenal perforated ulcers, infected pancreatic necrosis, and splenic injuries Laparoscopy gives the primary advantages of a shorter hospital stay, a quicker procedure, and faster recovery without complications. Rapid recovery is connected with early enteral feeding. Adequate nutritional support aids in maintaining homeostasis and, as a result, enhances immunity, thereby decreasing the incidence of wound infection. Laparoscopy should be considered with caution whenever abdominal access is considered difficult, as in cases of organ enlargement, adhesion, and bowel distension. In actuality, creating the pneumoperitoneum is an essential step in the procedure. Increased intraperitoneal pressure produces cardio-respiratory and neurological effects.
In this study, the investigators designed a retrospective observational study to present our experience in assessing the outcomes of a laparoscopic approach in emergent upper abdominal surgery in terms of intraoperative and postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Between June 2017 and June 2020, 215 patients were admitted to Zagazig University Hospital's emergency surgical unit with clinical diagnoses of upper G.I.T. emergencies, namely acute cholecystitis, perforated P.U., acute necrotizing pancreatitis, and splenic trauma. The work has been reported following STROBE guidelines. To be included in the study, patients must meet the following criteria: >18 years of both sexes complaining of acute upper G.I.T. emergencies and undergoing laparoscopic surgeries, namely acute cholecystitis, perforated peptic ulcer, pancreatic necrosis, and splenic injuries. < 18 years of age and open surgeries for upper G.I.T. emergency surgeries were excluded.
Key inclusion criteria (1 listed)
- clinical diagnoses of upper G.I.T. emergencies, namely acute cholecystitis, perforated P.U., acute necrotizing pancreatitis, and splenic trauma.
Key exclusion criteria (2 listed)
- < 18 years of age and
- open surgeries for upper G.I.T.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopy in upper abdominal surgical emergencies in adultsevaluation the role of laparoscopy in upper GIT emergencies in adults | Procedure or surgery | – |
Primary outcome
intraoperative complications requiring conversion
Time frame: 2 years
the number of patients converted to open approach
1 secondary outcome
postoperative complications requiring reintervention
Time frame: within 2 years of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Abdomen, run by Zagazig University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative complications requiring conversion (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.