AppendicitisNCT05637554
Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview
A study testing Laparoscopic appendectomy using clipping. and Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix. in people with Appendicitis, run by Assiut University.
Trial summary
The investigators aim to compare between laparoscopic clipping and extracorporeal ligation in complicated appendicitis regarding safety, efficacy, operative time, postoperative outcome, hospital stay and complications. Read more about this study
- Who is it for?
- Ages 7 to 60 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Laparoscopic appendectomy using clipping. and Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Jan 2024
- 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 7 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Acute complicated appendicitis.
- Perforated appendicitis (diagnosed intraoperatively)
- Patients who will undergo laparoscopic appendectomy.
Who cannot join
- Patients with straight forward appendectomy.
- Patients who are not fit for laparoscopic appendectomy.
Trial locations and contacts
No sites are listed yet.
Mohamed Ahmed Hamed Mohamed Elfoly, Resident Doctor contact
About this study
Official title: Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview, Prospective Randomized Comparative Study
The investigators aim to compare between laparoscopic clipping and extracorporeal ligation in complicated appendicitis regarding safety, efficacy, operative time, postoperative outcome, hospital stay and complications.
Read the detailed description
Appendectomy has become one of the most commonly performed emergency abdominal operations since it's description by McBurney in the 1890s. Since laparoscopic appendectomy was first described in 1983, there is an increase in the general trend towards performing this surgery using laparoscopy instead of open technique as this approach shows better pain score, lesser use of analgesics, less operative complications, better post operative recovery, less hospital stay and rapid return to normal work.
There are many methods for securing the base of the appendix, some of which are expensive others are not available or technically demanding. In this study the investigators aim to compare between extracorporeal ligation and clipping techniques regarding feasibility, safety, efficacy, operative time, postoperative outcome and complications especially in complicated appendicitis.
AS management of complicated appendicitis laparoscopically is possible, secure and can lead to a little occurrence of infectious complications, fewer post-operative pain, quick revival and improve cosmesis so the investigators will do a prospective clinical trial comparative study between two common techniques to determine the best one in management of complicated cases.
- Conditions
- Appendicitis
- Being tested
- Laparoscopic appendectomy using clipping., Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic appendectomy using clipping.Procedure or surgery
Laparoscopic appendectomy using clipping to secure the base of the appendix.
Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.Procedure or surgery
Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic clipping appendectomy | Active comparator | This group will undergo laparoscopic clipping of the base of the appendix during laparoscopic appendectomy. Receives: Procedure: Laparoscopic appendectomy using clipping. |
| Laparoscopic extracorporeal ligation appendectomy | Active comparator | This group will undergo laparoscopic extracorporeal ligation of the base of the appendix during laparoscopic appendectomy. Receives: Procedure: Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Time of the total procedure.
Measured: After procedure completion, an average of 1 hour.
Postoperative complications
All patients will be observed postoperatively for occurrence of complications as leakage, pelvic abscess, wound infection
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Hospital stay
Duration of hospital stay
Measured: Through the patient's hospital stay, an average of 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study startFeb 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be divided randomly into two groups, in the first group the investigators will use clipping in securing the base of the appendix but in other groups investigators will use extracorporeal ligation.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed Mohamed Elfoly, Assiut University
- Investigators
- Hisham Ali Riad Shaban, Professor, Principal investigator, Assiut UniversityMoustafa Mahmoud Ebrahem, Principal investigator, Assiut UniversityMoustafa Ali Sayed Mahmoud, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637554
- Sponsor's protocol ID
- Laparoscopic appendectomy.
- Status last verified
- Jan 2023
- First submitted
- 9 Nov 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bessoff KE, Choi J, Wolff CJ, Kashikar A, Carlos GM, Caddell L, Khan RI, Stave CD, Spain DA, Forrester JD. Evidence-based surgery for laparoscopic appendectomy: A stepwise systematic review. Surg Open Sci. 2021 Aug 26;6:29-39. doi: 10.1016/j.sopen.2021.08.001. eCollection 2021 Oct.
PubMed 34604728Casas MA, Dreifuss NH, Schlottmann F. High-volume center analysis and systematic review of stump appendicitis: solving the pending issue. Eur J Trauma Emerg Surg. 2022 Jun;48(3):1663-1672. doi: 10.1007/s00068-021-01707-y. Epub 2021 Jun 3.
PubMed 34085112Mannu GS, Sudul MK, Bettencourt-Silva JH, Cumber E, Li F, Clark AB, Loke YK. Closure methods of the appendix stump for complications during laparoscopic appendectomy. Cochrane Database Syst Rev. 2017 Nov 13;11(11):CD006437. doi: 10.1002/14651858.CD006437.pub3.
PubMed 29190038Delibegovic S, Mehmedovic Z. The influence of the different forms of appendix base closure on patient outcome in laparoscopic appendectomy: a randomized trial. Surg Endosc. 2018 May;32(5):2295-2299. doi: 10.1007/s00464-017-5924-z. Epub 2017 Nov 2.
PubMed 29098432
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Clipping Versus Extracorporeal Ligation in Complicated Appendicitis Upper Egypt Overview, Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05637554
- Acronym / sponsor ID
- Laparoscopic appendectomy.
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 5 Dec 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.
The investigators aim to compare between laparoscopic clipping and extracorporeal ligation in complicated appendicitis regarding safety, efficacy, operative time, postoperative outcome, hospital stay and complications.
Detailed description
Appendectomy has become one of the most commonly performed emergency abdominal operations since it's description by McBurney in the 1890s. Since laparoscopic appendectomy was first described in 1983, there is an increase in the general trend towards performing this surgery using laparoscopy instead of open technique as this approach shows better pain score, lesser use of analgesics, less operative complications, better post operative recovery, less hospital stay and rapid return to normal work.
There are many methods for securing the base of the appendix, some of which are expensive others are not available or technically demanding. In this study the investigators aim to compare between extracorporeal ligation and clipping techniques regarding feasibility, safety, efficacy, operative time, postoperative outcome and complications especially in complicated appendicitis.
AS management of complicated appendicitis laparoscopically is possible, secure and can lead to a little occurrence of infectious complications, fewer post-operative pain, quick revival and improve cosmesis so the investigators will do a prospective clinical trial comparative study between two common techniques to determine the best one in management of complicated cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be divided randomly into two groups, in the first group the investigators will use clipping in securing the base of the appendix but in other groups investigators will use extracorporeal ligation.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic clipping appendectomy | Active comparator | Procedure: Laparoscopic appendectomy using clipping.This group will undergo laparoscopic clipping of the base of the appendix during laparoscopic appendectomy. |
| Laparoscopic extracorporeal ligation appendectomy | Active comparator | Procedure: Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.This group will undergo laparoscopic extracorporeal ligation of the base of the appendix during laparoscopic appendectomy. |
Who may qualify
- Ages
- 7 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Acute complicated appendicitis.
- Perforated appendicitis (diagnosed intraoperatively)
- Patients who will undergo laparoscopic appendectomy.
Key exclusion criteria (2 listed)
- Patients with straight forward appendectomy.
- Patients who are not fit for laparoscopic appendectomy.
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 appendectomy using clipping.Laparoscopic appendectomy using clipping to secure the base of the appendix. | Procedure or surgery | Laparoscopic clipping appendectomy |
| Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix.Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix. | Procedure or surgery | Laparoscopic extracorporeal ligation appendectomy |
Primary outcome
Operative time
Time frame: After procedure completion, an average of 1 hour.
Time of the total procedure.
Postoperative complications
Time frame: Through study completion, an average of 1 year.
All patients will be observed postoperatively for occurrence of complications as leakage, pelvic abscess, wound infection
1 secondary outcome
Hospital stay
Time frame: Through the patient's hospital stay, an average of 1 week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Background: PubMed 34604728Bessoff KE, Choi J, Wolff CJ, Kashikar A, Carlos GM, Caddell L, Khan RI, Stave CD, Spain DA, Forrester JD. Evidence-based surgery for laparoscopic appendectomy: A stepwise systematic review. Surg Open Sci. 2021 Aug 26;6:29-39. doi: 10.1016/j.sopen.2021.08.001. eCollection 2021 Oct.
- Background: PubMed 34085112Casas MA, Dreifuss NH, Schlottmann F. High-volume center analysis and systematic review of stump appendicitis: solving the pending issue. Eur J Trauma Emerg Surg. 2022 Jun;48(3):1663-1672. doi: 10.1007/s00068-021-01707-y. Epub 2021 Jun 3.
- Background: PubMed 29190038Mannu GS, Sudul MK, Bettencourt-Silva JH, Cumber E, Li F, Clark AB, Loke YK. Closure methods of the appendix stump for complications during laparoscopic appendectomy. Cochrane Database Syst Rev. 2017 Nov 13;11(11):CD006437. doi: 10.1002/14651858.CD006437.pub3.
- Background: PubMed 29098432Delibegovic S, Mehmedovic Z. The influence of the different forms of appendix base closure on patient outcome in laparoscopic appendectomy: a randomized trial. Surg Endosc. 2018 May;32(5):2295-2299. doi: 10.1007/s00464-017-5924-z. Epub 2017 Nov 2.
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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.
Mohamed Ahmed Hamed Mohamed Elfoly, Resident Doctor contact
Hisham Ali Riad Shaban, Professor principal investigator
Assiut University
Moustafa Mahmoud Ebrahem principal investigator
Assiut University
Moustafa Ali Sayed Mahmoud principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic appendectomy using clipping. and Laparoscopic appendectomy using extracorporeal ligation to secure the base of the appendix. in people with 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 3 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: status not confirmed, as of the sponsor's last update on 1 Feb 2023. 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?
Contact Mohamed Ahmed Hamed Mohamed Elfoly, Resident Doctor (+201005126585, Mohamed.14223992@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: After procedure completion, an average of 1 hour.). The study lists 2 primary outcomes in all. 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 NCT05637554, which also lists 4 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 1 Feb 2023.