General SurgeryNCT06158308
Outcome of Laparoscopic Appendicectomy Versus Open Appendicectomy in Sudanese Patients
An observational study of General Surgery, run by National Center for Gastroentestinal and Liver Disease at 1 site in Sudan.
Trial summary
Background: Laparoscopic appendectomy as a minimal invasive procedure had low morbidity and mortality. It affords a direct diagnosis of the problem, allows determination of the appropriate treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Surgery
- What is being tested?
- Laproscopic Appendicectomy and Open Appendicectomy
- Type of treatment
- Surgery or procedure
- How many people
- 340 participants
- Where
- 1 siteSudan
- Study dates
- 13 Jan 2019to 10 Jan 2021
- 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: The study includes all patients those underwent appendectomy during the study period.
Who may be able to join
- All patients in the study period who underwent appendectomy were included.
Who cannot join
- Patientspresented with complicated appendicitis
- Acute appendicitis with comorbiditites
- Pregnant ladies
- Patients of stump appendicitis .
- Patient with inadequate data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Laparoscopic Appendicectomy Versus Open Appendicectomy in Sudanese Patients: Cross-sectional Study
Background: Laparoscopic appendectomy as a minimal invasive procedure had low morbidity and mortality. It affords a direct diagnosis of the problem, allows determination of the appropriate treatment. Open appendectomy is global treatment of acute appendicitis can be done by many incisions, and associated with considerable complications.
Materials and Methods: This is a cross sectional descriptive hospital-based study to study the outcome of laparoscopic appendectomy versus open appendectomy at Elmak Nimer University Hospital over the study period. All patients in the study period who underwent appendectomy was included, data is collected through standard structured data collection sheet and analyzed by using SPSS v24.0.
- Conditions
- General Surgery
- Being tested
- Laproscopic Appendicectomy, Open Appendicectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laproscopic AppendicectomyProcedure or surgery
Also called Regular surgical site dressing
A type of surgery done without a large incision. Instead, from 1 to 3 tiny cuts are made. A long, thin tube called a laparoscope is put into one of the incisions. It has a tiny video camera and surgical tools.
Open AppendicectomyProcedure or surgery
Also called Regular surgical site dressing
A cut or incision about 2 to 4 inches long is made in the lower right-hand side of your belly or abdomen. The appendix is taken out through the incision.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Appendicectomy | Not described Receives: Procedure: Laproscopic Appendicectomy | |
| Open Appendicectomy | Not described Receives: Procedure: Open Appendicectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of post-operative complications
the rate of postoperative complications, such as surgical site infections, intra-abdominal abscess formation, and other adverse events. The comparison would help assess the efficacy and safety of each surgical approach in the context of appendectomies.
Measured: Jan 2019 - Jan 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start13 Jan 2019
- Primary completion1 Jan 2021
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Gastroentestinal and Liver Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158308
- Sponsor's protocol ID
- GastroentestinalLiver
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Laparoscopic Appendicectomy Versus Open Appendicectomy in Sudanese Patients: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06158308
- Acronym / sponsor ID
- GastroentestinalLiver
- Conditions
- General Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- National Center for Gastroentestinal and Liver DiseaseUniversity, hospital or other
- Study start
- 13 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 6 Dec 2023 (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.
Background: Laparoscopic appendectomy as a minimal invasive procedure had low morbidity and mortality. It affords a direct diagnosis of the problem, allows determination of the appropriate treatment. Open appendectomy is global treatment of acute appendicitis can be done by many incisions, and associated with considerable complications.
Materials and Methods: This is a cross sectional descriptive hospital-based study to study the outcome of laparoscopic appendectomy versus open appendectomy at Elmak Nimer University Hospital over the study period. All patients in the study period who underwent appendectomy was included, data is collected through standard structured data collection sheet and analyzed by using SPSS v24.0.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Appendicectomy | – | Procedure: Laproscopic Appendicectomy |
| Open Appendicectomy | – | Procedure: Open Appendicectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study includes all patients those underwent appendectomy during the study period.
Key inclusion criteria (1 listed)
- All patients in the study period who underwent appendectomy were included.
Key exclusion criteria (5 listed)
- Patientspresented with complicated appendicitis
- Acute appendicitis with comorbiditites
- Pregnant ladies
- Patients of stump appendicitis .
- Patient with inadequate data
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 |
|---|---|---|
| Laproscopic AppendicectomyAlso: Regular surgical site dressingA type of surgery done without a large incision. Instead, from 1 to 3 tiny cuts are made. A long, thin tube called a laparoscope is put into one of the incisions. It has a tiny video camera and surgical tools. | Procedure or surgery | Laparoscopic Appendicectomy |
| Open AppendicectomyAlso: Regular surgical site dressingA cut or incision about 2 to 4 inches long is made in the lower right-hand side of your belly or abdomen. The appendix is taken out through the incision. | Procedure or surgery | Open Appendicectomy |
Primary outcome
The rate of post-operative complications
Time frame: Jan 2019 - Jan 2021
the rate of postoperative complications, such as surgical site infections, intra-abdominal abscess formation, and other adverse events. The comparison would help assess the efficacy and safety of each surgical approach in the context of appendectomies.
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 6 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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 General Surgery, run by National Center for Gastroentestinal and Liver Disease at 1 site in Sudan.
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 5 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 6 Dec 2023. 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 Sudan. 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?
The rate of post-operative complications (time frame: Jan 2019 - Jan 2021). 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 6 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.