Perforated AppendicitisNCT03267082
Evaluation the Role of Laparoscopic Management of Perforated Appendicitis
A study testing Laparoscopic management of perforated appendicitis in people with Perforated Appendicitis, run by Assiut University.
Trial summary
A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its advantages, such as the aesthetic appearance of the wound, less postoperative pain, and faster recovery which facilitates early discharge, have been highlighted, and the number of procedures performed has been continuously increasing. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Perforated Appendicitis
- What is being tested?
- Laparoscopic management of perforated appendicitis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2017to 15 Mar 2019
- Phase
- Interventional
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of acute perforated appendicitis
- fit for laparoscopy and general anesthesia.
- written informed consent.
- short term outcome data and agree to provide contact information.
Who cannot join
- high risk for general anesthesia.
- Appendicular abscess and appendicular mass .
- ongoing infections including chest infections .
- Children and pregnant females .
About this study
A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its advantages, such as the aesthetic appearance of the wound, less postoperative pain, and faster recovery which facilitates early discharge, have been highlighted, and the number of procedures performed has been continuously increasing.
Read the detailed description
The LA was performed mostly on uncomplicated appendicitis due to negative opinions about its safety when it was first introduced. However, the application of the procedure has been extended to complicated appendicitis (CA), and it is now considered as an alternative procedure to an open appendectomy (OA) as its safety record has improved . Nevertheless, it is still controversial because there are still concerns about surgical difficulties in managing CA with laparoscopy, overall surgery time, possible post-op complications and conversion to an OA during the surgery.
this study aimed to evaluate the safety and the efficacy of LA for managing perforated appendicitis.
- Conditions
- Perforated Appendicitis
- Being tested
- Laparoscopic management of perforated appendicitis
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic management of perforated appendicitisOther
- Insertion of Ports
- Exposure of the Appendix
- peritoneal toilet and aspiration of pus after abdominal exposure
- Isolation of Mesoappendicular Artery
- Clipping and Dividing of the Artery
- Application of 3 x Endoloops
- Division of the Appendix
- Retrieval of the Appendix in an Endobag
| Study group | Role | What they receive |
|---|---|---|
| Evaluation the role of Laparoscopic management of perforated a | Experimental | Not described Receives: Other: Laparoscopic management of perforated appendicitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
early recovery
recovery within 2 days
Measured: 2 day
Secondary outcomes (1)
wound cosmetic appearance
no scare of incision post laporscopic mangement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start15 Sep 2017 (estimated)
- Primary completion15 Mar 2019 (estimated)
- Study completion15 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perforated AppendicitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samir hosny mahmoud mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267082
- Sponsor's protocol ID
- ERLMPA
- Status last verified
- Aug 2017
- First submitted
- 20 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. doi: 10.1055/s-2007-1021466.
PubMed 6221925Frazee RC, Bohannon WT. Laparoscopic appendectomy for complicated appendicitis. Arch Surg. 1996 May;131(5):509-11; discussion 511-3. doi: 10.1001/archsurg.1996.01430170055010.
PubMed 8624197
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Role of Laparoscopic Management of Perforated Appendicitis
- ClinicalTrials.gov ID
- NCT03267082
- Acronym / sponsor ID
- ERLMPA
- Conditions
- Perforated Appendicitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2017 (estimated)
- Primary completion
- 15 Mar 2019 (estimated)
- Study completion
- 15 Mar 2019 (estimated)
- First posted
- 30 Aug 2017 (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.
A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its advantages, such as the aesthetic appearance of the wound, less postoperative pain, and faster recovery which facilitates early discharge, have been highlighted, and the number of procedures performed has been continuously increasing.
Detailed description
The LA was performed mostly on uncomplicated appendicitis due to negative opinions about its safety when it was first introduced. However, the application of the procedure has been extended to complicated appendicitis (CA), and it is now considered as an alternative procedure to an open appendectomy (OA) as its safety record has improved . Nevertheless, it is still controversial because there are still concerns about surgical difficulties in managing CA with laparoscopy, overall surgery time, possible post-op complications and conversion to an OA during the surgery.
this study aimed to evaluate the safety and the efficacy of LA for managing perforated appendicitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation the role of Laparoscopic management of perforated a | Experimental | Other: Laparoscopic management of perforated appendicitis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of acute perforated appendicitis
- fit for laparoscopy and general anesthesia.
- written informed consent.
- short term outcome data and agree to provide contact information.
Key exclusion criteria (4 listed)
- high risk for general anesthesia.
- Appendicular abscess and appendicular mass .
- ongoing infections including chest infections .
- Children and pregnant females .
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 management of perforated appendicitis1. Insertion of Ports 2. Exposure of the Appendix 3. peritoneal toilet and aspiration of pus after abdominal exposure 4. Isolation of Mesoappendicular Artery 5. Clipping and Dividing of the Artery 6. Application of 3 x Endoloops 7. Division of the Appendix 8. Retrieval of the Appendix in an Endobag | Other | Evaluation the role of Laparoscopic management of perforated a |
Primary outcome
early recovery
Time frame: 2 day
recovery within 2 days
1 secondary outcome
wound cosmetic appearance
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Results publication: PubMed 6221925Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64. doi: 10.1055/s-2007-1021466.
- Results publication: PubMed 8624197Frazee RC, Bohannon WT. Laparoscopic appendectomy for complicated appendicitis. Arch Surg. 1996 May;131(5):509-11; discussion 511-3. doi: 10.1001/archsurg.1996.01430170055010.
- Individual participant dataSharing planned: Undecided
Related trials for Perforated Appendicitis
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Effect of Probiotic's Consumption on Several Markers in Perforated Appendix Patients With Diffuse Peritonitis
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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?
A study testing Laparoscopic management of perforated appendicitis in people with Perforated Appendicitis, run by Assiut 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Aug 2017. 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?
Results are not available in the source record.
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?
early recovery (time frame: 2 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03267082, which also lists 2 linked publications.
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 30 Aug 2017.