Laparoscopic SurgeryreverseNCT05283733
Open to Laparoscopic Reverse Conversion of Perforated Appendicitis
A study testing reverse conversion technique in people with Laparoscopic Surgery and Acute Appendicitis With Rupture, run by Zagazig University at 1 site in Egypt.
Trial summary
A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in management of Acute Perforated Appendicitis Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Laparoscopic Surgery, Acute Appendicitis With Rupture, Sepsis
- What is being tested?
- reverse conversion technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2018to 25 Dec 2021
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- symptoms consistent with acute perforated appendicitis,
- had ultrasound or computed tomography (CT) evidence of acute perforated appendicitis,
- ages ranging from 16 to 65 years.
Who cannot join
- radiological evidence of appendicular mass,
- septic shock or multi-organ failure (MOF) at presentation,
- Diabetes Mellitus (DM), renal failure, morbid obesity
- recent (6-month) history of thromboembolic disease
- immunomodulators,
- a history of inflammatory bowel disease (IBD),
- postoperative pathological report of the removed appendix revealed carcinoid or Crohn's disease,
- American Society of Anesthesiology (ASA) classification more than II.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in Management of Acute Perforated Appendicitis
A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in management of Acute Perforated Appendicitis
Read the detailed description
Introduction: Acute appendicitis (AA), a frequent intra-abdominal surgical pathology, necessitates a thorough awareness of its symptoms, examination, diagnosis, and total surgical management. The surgical approach to AA is appendectomy; nevertheless, the medical literature continues to argue the merits of open vs laparoscopic surgery. As with other laparoscopic surgical techniques, the literature reports lower discomfort, earlier resumption of oral feeding and shorter hospital stay following laparoscopic appendectomy (LA) as compared to open appendectomy (OA). Additionally, laparoscopy has some drawbacks such as greater cost and lengthier operating durations as compared to open surgery. The goal of this clinical study: was to compare open appendectomy versus laparoscopic conversion from open (reverse conversion) for the treatment of acute perforated appendicitis in our setting. Patients and procedures: 426 patients had perforated appendectomy and divided between two groups: group A (interventional) 213 patients who were subjected to the reverse conversion technique and group B (control)213 patients who were operated by the open technique. The key end goals for comparing both groups were the rates of intraabdominal abscess, rates of wound infection, rates of ileus and rates of reoperation. The hospital length of stay and the operative time were used as secondary end goals for comparison.
- Being tested
- reverse conversion technique
- Keywords
- laparoscopic, appendectomy, reverse conversion, reoperation, intraabdominal abscesses
- Medical subject headings
- Sepsis, Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reverse conversion techniqueProcedure or surgery
Also called laparoscopic lavage
converting open appendectomy to laparoscopic technique for proper control of intraabdominal sepsis
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | the group who was subjected to the reverse conversion technique Receives: Procedure: reverse conversion technique |
| group B | No intervention | the control group who was completed by open technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rates of intraabdominal abscess
rates of complications
Measured: 3 months post operative
rates of wound infection
rates of complications
Measured: 3 months post operative
rates of ileus
Measured: Baseline (Hospital admission)
rates of reoperation
Measured: 3 months post operative
Secondary outcomes (2)
The hospital length of stay
the length of hospital stay
Measured: up to 3 months
the operative time
Time of performing the procedures
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start18 Jan 2018
- Primary completion15 Dec 2021
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed lotfy, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283733
- Sponsor's protocol ID
- ZUH 235
- Acronym
- reverse
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in Management of Acute Perforated Appendicitis
- ClinicalTrials.gov ID
- NCT05283733
- Acronym / sponsor ID
- reverse / ZUH 235
- Keywords
- laparoscopic, appendectomy, reverse conversion, reoperation, intraabdominal abscesses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 17 Mar 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.
A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in management of Acute Perforated Appendicitis
Detailed description
Introduction: Acute appendicitis (AA), a frequent intra-abdominal surgical pathology, necessitates a thorough awareness of its symptoms, examination, diagnosis, and total surgical management. The surgical approach to AA is appendectomy; nevertheless, the medical literature continues to argue the merits of open vs laparoscopic surgery. As with other laparoscopic surgical techniques, the literature reports lower discomfort, earlier resumption of oral feeding and shorter hospital stay following laparoscopic appendectomy (LA) as compared to open appendectomy (OA). Additionally, laparoscopy has some drawbacks such as greater cost and lengthier operating durations as compared to open surgery. The goal of this clinical study: was to compare open appendectomy versus laparoscopic conversion from open (reverse conversion) for the treatment of acute perforated appendicitis in our setting. Patients and procedures: 426 patients had perforated appendectomy and divided between two groups: group A (interventional) 213 patients who were subjected to the reverse conversion technique and group B (control)213 patients who were operated by the open technique. The key end goals for comparing both groups were the rates of intraabdominal abscess, rates of wound infection, rates of ileus and rates of reoperation. The hospital length of stay and the operative time were used as secondary end goals for comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: reverse conversion techniquethe group who was subjected to the reverse conversion technique |
| group B | No intervention | –the control group who was completed by open technique |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- symptoms consistent with acute perforated appendicitis,
- had ultrasound or computed tomography (CT) evidence of acute perforated appendicitis,
- ages ranging from 16 to 65 years.
Key exclusion criteria (8 listed)
- radiological evidence of appendicular mass,
- septic shock or multi-organ failure (MOF) at presentation,
- Diabetes Mellitus (DM), renal failure, morbid obesity
- recent (6-month) history of thromboembolic disease
- immunomodulators,
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 |
|---|---|---|
| reverse conversion techniqueAlso: laparoscopic lavageconverting open appendectomy to laparoscopic technique for proper control of intraabdominal sepsis | Procedure or surgery | group A |
Primary outcome
the rates of intraabdominal abscess
Time frame: 3 months post operative
rates of complications
rates of wound infection
Time frame: 3 months post operative
rates of complications
rates of ileus
Time frame: Baseline (Hospital admission)
rates of reoperation
Time frame: 3 months post operative
2 secondary outcomes
The hospital length of stay
Time frame: up to 3 months
the operative time
Time frame: Intraoperative
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 17 Mar 2022.
- 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?
A study testing reverse conversion technique in people with Laparoscopic Surgery and Acute Appendicitis With Rupture, 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 3 inclusion and 8 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 17 Mar 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?
the rates of intraabdominal abscess (time frame: 3 months post operative). The study lists 4 primary outcomes in all. 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 17 Mar 2022; AzTrials last refreshed its copy on 26 Oct 2026.