AppendicitisNCT07879235
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
A study testing Laparoscopic Appendectomy and Open Appendectomy in people with Appendicitis and Perforated Appendicitis, run by Assiut University.
Trial summary
Acute appendicitis is one of the most common surgical emergencies in children. In complicated cases, where the appendix has perforated, become gangrenous, or caused peritonitis and purulent contamination, determining the optimal surgical approach remains an important clinical question. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Appendicitis, Perforated Appendicitis, Gangrenous Appendicitis
- What is being tested?
- Laparoscopic Appendectomy and Open Appendectomy
- Type of treatment
- 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
- Nov 2026to Dec 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients with acute appendicitis requiring operative management.
- Intraoperative confirmation of complicated appendicitis.
- Patients within the pediatric age range adopted by the study center.
- Written informed consent from the parent or legal guardian.
Who cannot join
- Uncomplicated acute appendicitis.
- Appendicular mass managed conservatively.
- Appendicular abscess managed initially by drainage without appendectomy.
- Previous major abdominal surgery likely to interfere with laparoscopic access.
- Severe cardiopulmonary disease contraindicating pneumoperitoneum.
- Bleeding disorders or other major contraindications to surgery.
- Refusal of consent.
About this study
Acute appendicitis is one of the most common surgical emergencies in children. In complicated cases, where the appendix has perforated, become gangrenous, or caused peritonitis and purulent contamination, determining the optimal surgical approach remains an important clinical question. While laparoscopic appendectomy is widely used for uncomplicated cases, this study aims to evaluate its safety, clinical effectiveness, and postoperative outcomes compared with conventional open appendectomy in children with complicated appendicitis.
A total of 100 pediatric patients diagnosed with complicated acute appendicitis will participate in this prospective comparative study, divided into two groups:
Read more
- Group A: 50 patients undergoing laparoscopic appendectomy using a standard minimally invasive three-port technique.
- Group B: 50 patients undergoing conventional open appendectomy via a standard right lower-quadrant incision.
The primary goal is to compare the overall rate of postoperative complications between the two operative techniques. Researchers will also assess secondary outcomes, including operative time, intraoperative complications, conversion to open surgery, postoperative pain, time to resume oral feeding, duration of intravenous antibiotics, length of hospital stay, wound infections, intra-abdominal abscesses, bowel obstruction, readmissions, and reoperations. All participants will be evaluated during their hospital admission and followed up for 30 days postoperatively.
- Being tested
- Laparoscopic Appendectomy, Open Appendectomy
- Keywords
- Laparoscopic appendectomy, Open appendectomy, Complicated appendicitis, Pediatric appendicitis, Surgical site infection, Intra-abdominal abscess, Minimally invasive surgery
- Medical subject headings
- Appendicitis, Peritonitis, Surgical Wound Infection, Abdominal Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic AppendectomyProcedure or surgery
Laparoscopic appendectomy performed under general anesthesia via a three-port technique (periumbilical camera port using Hasson open technique, 5 mm right lower quadrant port, and 10 mm suprapubic port). The mesoappendix is dissected, and the appendicular artery is skeletonized, secured with clips, and divided. The appendicular base is secured using three endoloops and divided between the second and third loop. The appendix is extracted in an endobag through the umbilical port. Peritoneal lavage, pus aspiration, and drain placement are performed based on operative findings. Incisions are closed in layers.
Open AppendectomyProcedure or surgery
Conventional open appendectomy performed under general anesthesia through a standard right lower-quadrant incision (e.g., McBurney or Lanz). The cecum and appendix are mobilized into the field. The mesoappendix and appendicular artery are ligated and divided, followed by ligation and division of the appendicular base. Peritoneal contamination is managed with peritoneal toilet, suction, and drainage as indicated by operative findings. The wound is closed in anatomical layers.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Laparoscopic Appendectomy | Experimental | Pediatric patients undergoing laparoscopic appendectomy under general anesthesia using a standard 3-port technique (periumbilical camera port, 5 mm right lower quadrant port, and 10 mm suprapubic port). The mesoappendix and appendicular artery are clipped and divided, the appendicular base is secured with three endoloops, and the specimen is retrieved in an endobag through the umbilical port. Peritoneal lavage, aspiration of pus, and drain insertion are performed as indicated based on operative findings. Receives: Procedure: Laparoscopic Appendectomy |
| Group B: Open Appendectomy | Active comparator | Pediatric patients undergoing conventional open appendectomy under general anesthesia through a standard right lower-quadrant incision. The appendix is mobilized, the mesoappendix and appendicular base are ligated and divided by standard surgical technique, and peritoneal contamination is addressed with peritoneal toilet and drain insertion as indicated based on operative findings. Receives: Procedure: Open Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Postoperative Complications
Calculated as the percentage of pediatric patients who develop at least one postoperative complication (including surgical-site infection, intra-abdominal abscess or collection, prolonged postoperative ileus, mechanical bowel obstruction, or need for reoperation) following appendectomy.
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 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, Ahmed Hassan Mohamed Sleem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879235
- Sponsor's protocol ID
- Lap vs Open Appendectomy
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
- ClinicalTrials.gov ID
- NCT07879235
- Acronym / sponsor ID
- Lap vs Open Appendectomy
- Keywords
- Laparoscopic appendectomy, Open appendectomy, Complicated appendicitis, Pediatric appendicitis, Surgical site infection, Intra-abdominal abscess, Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Oct 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.
Acute appendicitis is one of the most common surgical emergencies in children. In complicated cases, where the appendix has perforated, become gangrenous, or caused peritonitis and purulent contamination, determining the optimal surgical approach remains an important clinical question. While laparoscopic appendectomy is widely used for uncomplicated cases, this study aims to evaluate its safety, clinical effectiveness, and postoperative outcomes compared with conventional open appendectomy in children with complicated appendicitis.
A total of 100 pediatric patients diagnosed with complicated acute appendicitis will participate in this prospective comparative study, divided into two groups:
- Group A: 50 patients undergoing laparoscopic appendectomy using a standard minimally invasive three-port technique.
- Group B: 50 patients undergoing conventional open appendectomy via a standard right lower-quadrant incision.
The primary goal is to compare the overall rate of postoperative complications between the two operative techniques. Researchers will also assess secondary outcomes, including operative time, intraoperative complications, conversion to open surgery, postoperative pain, time to resume oral feeding, duration of intravenous antibiotics, length of hospital stay, wound infections, intra-abdominal abscesses, bowel obstruction, readmissions, and reoperations. All participants will be evaluated during their hospital admission and followed up for 30 days postoperatively.
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: Laparoscopic Appendectomy | Experimental | Procedure: Laparoscopic AppendectomyPediatric patients undergoing laparoscopic appendectomy under general anesthesia using a standard 3-port technique (periumbilical camera port, 5 mm right lower quadrant port, and 10 mm suprapubic port). The mesoappendix and appendicular artery are clipped and divided, the appendicular base is secured with three endoloops, and the specimen is retrieved in an endobag through the umbilical port. Peritoneal lavage, aspiration of pus, and drain insertion are performed as indicated based on operative findings. |
| Group B: Open Appendectomy | Active comparator | Procedure: Open AppendectomyPediatric patients undergoing conventional open appendectomy under general anesthesia through a standard right lower-quadrant incision. The appendix is mobilized, the mesoappendix and appendicular base are ligated and divided by standard surgical technique, and peritoneal contamination is addressed with peritoneal toilet and drain insertion as indicated based on operative findings. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric patients with acute appendicitis requiring operative management.
- Intraoperative confirmation of complicated appendicitis.
- Patients within the pediatric age range adopted by the study center.
- Written informed consent from the parent or legal guardian.
Key exclusion criteria (7 listed)
- Uncomplicated acute appendicitis.
- Appendicular mass managed conservatively.
- Appendicular abscess managed initially by drainage without appendectomy.
- Previous major abdominal surgery likely to interfere with laparoscopic access.
- Severe cardiopulmonary disease contraindicating pneumoperitoneum.
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 AppendectomyLaparoscopic appendectomy performed under general anesthesia via a three-port technique (periumbilical camera port using Hasson open technique, 5 mm right lower quadrant port, and 10 mm suprapubic port). The mesoappendix is dissected, and the appendicular artery is skeletonized, secured with clips, and divided. The appendicular base is secured using three endoloops and divided between the second and third loop. The appendix is extracted in an endobag through the umbilical port. Peritoneal lavage, pus aspiration, and drain placement are performed based on operative findings. Incisions are closed in layers. | Procedure or surgery | Group A: Laparoscopic Appendectomy |
| Open AppendectomyConventional open appendectomy performed under general anesthesia through a standard right lower-quadrant incision (e.g., McBurney or Lanz). The cecum and appendix are mobilized into the field. The mesoappendix and appendicular artery are ligated and divided, followed by ligation and division of the appendicular base. Peritoneal contamination is managed with peritoneal toilet, suction, and drainage as indicated by operative findings. The wound is closed in anatomical layers. | Procedure or surgery | Group B: Open Appendectomy |
Primary outcome
Percentage of Participants With Postoperative Complications
Time frame: 30 days postoperatively
Calculated as the percentage of pediatric patients who develop at least one postoperative complication (including surgical-site infection, intra-abdominal abscess or collection, prolonged postoperative ileus, mechanical bowel obstruction, or need for reoperation) following appendectomy.
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 16 Oct 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 Laparoscopic Appendectomy and Open Appendectomy in people with Appendicitis and 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 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 16 Oct 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?
Percentage of Participants With Postoperative Complications (time frame: 30 days postoperatively). 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 16 Oct 2026.