Appendicular MassNCT07837531
Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass
A study testing Immediate Laparoscopic Appendectomy and Interval Laparoscopic Appendectomy in people with Appendicular Mass and Acute Appendicitis, run by Assiut University.
Trial summary
This study compares two standard treatment approaches for patients presenting with an appendicular mass, an inflammatory lump that forms when the appendix becomes severely inflamed and walled off by surrounding abdominal tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicular Mass, Acute Appendicitis, Appendiceal Phlegmon
- What is being tested?
- Immediate Laparoscopic Appendectomy and Interval Laparoscopic Appendectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adults aged 18 years or older
- Clinical diagnosis of appendicular mass confirmed by abdominal ultrasonography and/or abdominal CT scan
- Presentation within 72 hours of symptom onset
- Provision of written informed consent
Who cannot join
- Generalized peritonitis or perforation with free intraperitoneal air
- Appendicular abscess > 5 cm not amenable to percutaneous drainage
- History of previous abdominal surgeries (contraindication to laparoscopy)
- American Society of Anesthesiologists (ASA) physical status classification ≥ IV
- Severe shock or sepsis requiring preoperative intensive care unit (ICU) admission
- Suspected cecal malignancy or colonic neoplasm
- Pregnancy
About this study
Official title: Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass: A Comparative Study
This study compares two standard treatment approaches for patients presenting with an appendicular mass, an inflammatory lump that forms when the appendix becomes severely inflamed and walled off by surrounding abdominal tissues.
The traditional treatment involves conservative medical therapy using intravenous antibiotics followed by an elective interval surgery to remove the appendix 6 to 8 weeks later. Alternatively, advances in minimally invasive surgery allow for an immediate keyhole operation (laparoscopic appendectomy) performed during the initial hospital admission. The goal of this study is to evaluate which approach leads to shorter total hospital stays, faster recovery, and fewer complications.
Read more
Participants will be assigned to one of two treatment groups:
- Group A (Immediate Laparoscopic Appendectomy): Participants undergo laparoscopic surgery to remove the appendix within 24 hours of hospital admission.
- Group B (Interval Laparoscopic Appendectomy): Participants receive initial intravenous antibiotics in the hospital until symptoms resolve. After discharge, they return 6 to 8 weeks later for elective laparoscopic surgery.
Participants in both groups will be monitored throughout their hospital stay and will attend follow-up visits at 1, 3, and 6 months postoperatively to assess recovery, wound healing, and any potential complications.
- Conditions
- Appendicular Mass, Acute Appendicitis, Appendiceal Phlegmon, Appendicitis With Periappendicular Abscess
- Being tested
- Immediate Laparoscopic Appendectomy, Interval Laparoscopic Appendectomy
- Keywords
- Immediate appendectomy, Interval appendectomy, Laparoscopic appendectomy, Conservative management, Plastron appendicitis, Minimally invasive surgery, Complicated appendicitis
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Laparoscopic AppendectomyProcedure or surgery
Laparoscopic appendectomy performed within 24 hours of admission. The procedure is executed using a standard 3-port technique (one 10 mm umbilical camera port and two 5 mm working ports). It includes careful blunt and sharp adhesiolysis to identify and mobilize the appendix, appendectomy using an endoloop ligature or endoscopic stapler, peritoneal lavage with 3-5 liters of warm normal saline, and abdominal drain placement when clinically indicated.
Interval Laparoscopic AppendectomyProcedure or surgery
Initial conservative medical management with intravenous antibiotics (third-generation cephalosporin, metronidazole, and amikacin) and analgesics, monitored clinically and via ultrasonography every 48 hours until clinical improvement and discharge. Patients undergo elective interval laparoscopic appendectomy 6 to 8 weeks later using the standard 3-port laparoscopic technique.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Immediate Laparoscopic Appendectomy | Experimental | Patients undergo immediate laparoscopic appendectomy within 24 hours of admission. The procedure utilizes a standard 3-port laparoscopic technique (one 10 mm umbilical camera port and two 5 mm working ports), blunt and sharp adhesiolysis to isolate the inflamed appendix, appendix resection via endoloop or endoscopic stapler, warm saline peritoneal lavage (3-5 L), and abdominal drain placement if indicated. Receives: Procedure: Immediate Laparoscopic Appendectomy |
| Group B: Interval Laparoscopic Appendectomy | Active comparator | Patients receive initial conservative medical treatment with intravenous antibiotics (third-generation cephalosporin, metronidazole, and amikacin) along with analgesics, monitored via clinical examination and ultrasound every 48 hours until symptom resolution and discharge. Patients subsequently undergo elective interval laparoscopic appendectomy 6 to 8 weeks later using the same standard 3-port technique. Receives: Procedure: Interval Laparoscopic Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Length of Hospital Stay
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendicular MassStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youhanna Bahgat Hosny Loundy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837531
- Sponsor's protocol ID
- Immediate vs Interval LA
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass: A Comparative Study
- ClinicalTrials.gov ID
- NCT07837531
- Acronym / sponsor ID
- Immediate vs Interval LA
- Conditions
- Appendicular Mass, Acute Appendicitis, Appendiceal Phlegmon, Appendicitis With Periappendicular Abscess
- Keywords
- Immediate appendectomy, Interval appendectomy, Laparoscopic appendectomy, Conservative management, Plastron appendicitis, Minimally invasive surgery, Complicated appendicitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Sep 2026 (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.
This study compares two standard treatment approaches for patients presenting with an appendicular mass, an inflammatory lump that forms when the appendix becomes severely inflamed and walled off by surrounding abdominal tissues.
The traditional treatment involves conservative medical therapy using intravenous antibiotics followed by an elective interval surgery to remove the appendix 6 to 8 weeks later. Alternatively, advances in minimally invasive surgery allow for an immediate keyhole operation (laparoscopic appendectomy) performed during the initial hospital admission. The goal of this study is to evaluate which approach leads to shorter total hospital stays, faster recovery, and fewer complications.
Participants will be assigned to one of two treatment groups:
- Group A (Immediate Laparoscopic Appendectomy): Participants undergo laparoscopic surgery to remove the appendix within 24 hours of hospital admission.
- Group B (Interval Laparoscopic Appendectomy): Participants receive initial intravenous antibiotics in the hospital until symptoms resolve. After discharge, they return 6 to 8 weeks later for elective laparoscopic surgery.
Participants in both groups will be monitored throughout their hospital stay and will attend follow-up visits at 1, 3, and 6 months postoperatively to assess recovery, wound healing, and any potential complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Immediate Laparoscopic Appendectomy | Experimental | Procedure: Immediate Laparoscopic AppendectomyPatients undergo immediate laparoscopic appendectomy within 24 hours of admission. The procedure utilizes a standard 3-port laparoscopic technique (one 10 mm umbilical camera port and two 5 mm working ports), blunt and sharp adhesiolysis to isolate the inflamed appendix, appendix resection via endoloop or endoscopic stapler, warm saline peritoneal lavage (3-5 L), and abdominal drain placement if indicated. |
| Group B: Interval Laparoscopic Appendectomy | Active comparator | Procedure: Interval Laparoscopic AppendectomyPatients receive initial conservative medical treatment with intravenous antibiotics (third-generation cephalosporin, metronidazole, and amikacin) along with analgesics, monitored via clinical examination and ultrasound every 48 hours until symptom resolution and discharge. Patients subsequently undergo elective interval laparoscopic appendectomy 6 to 8 weeks later using the same standard 3-port technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Clinical diagnosis of appendicular mass confirmed by abdominal ultrasonography and/or abdominal CT scan
- Presentation within 72 hours of symptom onset
- Provision of written informed consent
Key exclusion criteria (7 listed)
- Generalized peritonitis or perforation with free intraperitoneal air
- Appendicular abscess > 5 cm not amenable to percutaneous drainage
- History of previous abdominal surgeries (contraindication to laparoscopy)
- American Society of Anesthesiologists (ASA) physical status classification ≥ IV
- Severe shock or sepsis requiring preoperative intensive care unit (ICU) admission
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 |
|---|---|---|
| Immediate Laparoscopic AppendectomyLaparoscopic appendectomy performed within 24 hours of admission. The procedure is executed using a standard 3-port technique (one 10 mm umbilical camera port and two 5 mm working ports). It includes careful blunt and sharp adhesiolysis to identify and mobilize the appendix, appendectomy using an endoloop ligature or endoscopic stapler, peritoneal lavage with 3-5 liters of warm normal saline, and abdominal drain placement when clinically indicated. | Procedure or surgery | Group A: Immediate Laparoscopic Appendectomy |
| Interval Laparoscopic AppendectomyInitial conservative medical management with intravenous antibiotics (third-generation cephalosporin, metronidazole, and amikacin) and analgesics, monitored clinically and via ultrasonography every 48 hours until clinical improvement and discharge. Patients undergo elective interval laparoscopic appendectomy 6 to 8 weeks later using the standard 3-port laparoscopic technique. | Procedure or surgery | Group B: Interval Laparoscopic Appendectomy |
Primary outcome
Total Length of Hospital Stay
Time frame: Up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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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.
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 Immediate Laparoscopic Appendectomy and Interval Laparoscopic Appendectomy in people with Appendicular Mass and Acute 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 7 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: opening soon, as of the sponsor's last update on 23 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Total Length of Hospital Stay (time frame: Up to 3 months). 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 23 Sep 2026.