EmergenciesNCT05584579
the Role of Laparoscopy in Lower Gastrointestinal Surgical Emergencies in Adults.
An observational study of Emergencies, run by Zagazig University at 1 site in Egypt.
Trial summary
Introduction: causes of lower abdominal pain caused by various GIT emergencies, including acute appendicitis, intestinal obstruction, acute perforated diverticulitis, obstructed hernia, and iatrogenic colon perforation. The role of Laparoscopy may be of diagnostic and therapeutic value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies
- What is being tested?
- laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 793 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 1 Apr 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Between April 2017 and April 2020, 793 patients were admitted to Zagazig University Hospital's emergency surgery unit with lower GIT emergencies, including acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations. To be eligible for the study, patients must meet all of the following criteria: be >18 years old, both sexes, and have undergone laparoscopic surgery for acute lower GIT emergencies such as acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations. The exclusion criteria were less than 18 years of age and open surgery. STROBE criteria were followed when reporting the work and registered in clinical trial.
Who may be able to join
- >18 years old, both sexes, and have undergone laparoscopic surgery for acute lower GIT emergencies such as acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations
Who cannot join
- less than 18 years of age and open surgery
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: causes of lower abdominal pain caused by various GIT emergencies, including acute appendicitis, intestinal obstruction, acute perforated diverticulitis, obstructed hernia, and iatrogenic colon perforation. The role of Laparoscopy may be of diagnostic and therapeutic value.
Methods: Between April 2017 and April 2020, 793 patients were admitted to Zagazig University Hospital's emergency surgery unit with lower GIT emergencies, including acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations.
Read the detailed description
An acute lower abdomen is typically caused by peritoneal irritation caused by an abdominal organ's inflammation, rupture, or a hollow organ obstruction. Patients with severe acute lower abdominal pain either proceed to the operative room or additional investigations or diagnostic Laparoscopy (DL). Laparoscopy should not be used routinely for every acute lower abdomen case due to anesthetic risks and morbidity .
Most hospitals do emergency abdominal surgeries, and laparotomy in these procedures is associated with high death rates (14 to 20%) . Laparoscopic surgery has become a standard method for abdominal emergencies as a diagnostic and therapeutic tool. It has even been employed in some situations of lower abdominal crises in recent years .
The general surgeon frequently faces diagnostic challenges in emergency abdominal conditions. The diagnosis is crucial for planning the appropriate abdominal incision and avoiding unnecessary surgery. Noninvasive diagnostic approaches such as radiological examinations are not always conclusive. Furthermore, they are costly and cannot be performed 24 hours a day in all hospital circumstances . A retrospective observational study was designed to analyze the outcomes of a laparoscopic technique in emergent lower GIT surgeries regarding intraoperative and postoperative outcomes.
- Conditions
- Emergencies
- Being tested
- laparoscopic surgery
- Keywords
- Emergency surgery, laparoscopy, lower abdominal surgery
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgeryProcedure or surgery
laparoscopic surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative complications
Measured: up to 2 years
Secondary outcomes (1)
postoperative complications
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 posted18 Oct 2022
- Study start1 Apr 2017
- Primary completion1 Apr 2020
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 793 participants (actual)
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
- NCT05584579
- Sponsor's protocol ID
- zagazig 13
- Status last verified
- Oct 2022
- First submitted
- 8 Oct 2022
- Last updated
- 18 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 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Role of Laparoscopy in Lower Gastrointestinal Surgical Emergencies in Adults.
- ClinicalTrials.gov ID
- NCT05584579
- Acronym / sponsor ID
- zagazig 13
- Conditions
- Emergencies
- Keywords
- Emergency surgery, laparoscopy, lower abdominal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 793 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 18 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: causes of lower abdominal pain caused by various GIT emergencies, including acute appendicitis, intestinal obstruction, acute perforated diverticulitis, obstructed hernia, and iatrogenic colon perforation. The role of Laparoscopy may be of diagnostic and therapeutic value.
Methods: Between April 2017 and April 2020, 793 patients were admitted to Zagazig University Hospital's emergency surgery unit with lower GIT emergencies, including acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations.
Detailed description
An acute lower abdomen is typically caused by peritoneal irritation caused by an abdominal organ's inflammation, rupture, or a hollow organ obstruction. Patients with severe acute lower abdominal pain either proceed to the operative room or additional investigations or diagnostic Laparoscopy (DL). Laparoscopy should not be used routinely for every acute lower abdomen case due to anesthetic risks and morbidity .
Most hospitals do emergency abdominal surgeries, and laparotomy in these procedures is associated with high death rates (14 to 20%) . Laparoscopic surgery has become a standard method for abdominal emergencies as a diagnostic and therapeutic tool. It has even been employed in some situations of lower abdominal crises in recent years .
The general surgeon frequently faces diagnostic challenges in emergency abdominal conditions. The diagnosis is crucial for planning the appropriate abdominal incision and avoiding unnecessary surgery. Noninvasive diagnostic approaches such as radiological examinations are not always conclusive. Furthermore, they are costly and cannot be performed 24 hours a day in all hospital circumstances . A retrospective observational study was designed to analyze the outcomes of a laparoscopic technique in emergent lower GIT surgeries regarding intraoperative and postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between April 2017 and April 2020, 793 patients were admitted to Zagazig University Hospital's emergency surgery unit with lower GIT emergencies, including acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations. To be eligible for the study, patients must meet all of the following criteria: be >18 years old, both sexes, and have undergone laparoscopic surgery for acute lower GIT emergencies such as acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations. The exclusion criteria were less than 18 years of age and open surgery. STROBE criteria were followed when reporting the work and registered in clinical trial.
Key inclusion criteria (1 listed)
- >18 years old, both sexes, and have undergone laparoscopic surgery for acute lower GIT emergencies such as acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations
Key exclusion criteria (1 listed)
- less than 18 years of age and open surgery
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 |
|---|---|---|
| laparoscopic surgerylaparoscopic surgery | Procedure or surgery | – |
Primary outcome
intraoperative complications
Time frame: up to 2 years
1 secondary outcome
postoperative complications
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 18 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergencies, run by Zagazig University at 1 site in Egypt.
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 1 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 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (time frame: up to 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 18 Oct 2022.