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Not yet recruitingNCT07879235Updated Oct 16, 2026

Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis

An interventional study of Laparoscopic Appendectomy and Open Appendectomy in Appendicitis, Perforated Appendicitis and Gangrenous Appendicitis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Updated Oct 16, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
1 Year to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Appendicitis
  • Perforated Appendicitis
  • Gangrenous Appendicitis
  • Peritonitis

Keywords

  • Laparoscopic appendectomy
  • Open appendectomy
  • Complicated appendicitis
  • Pediatric appendicitis
  • Surgical site infection
  • Intra-abdominal abscess
  • Minimally invasive surgery
03

In context

Appendicitis

417 studies on the registry are indexed under Appendicitis; 63 are open to participants now.

This study's planned enrollment of 100 is close to the median of 111 across 248 interventional studies indexed under Appendicitis.

Browse Appendicitis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Group A: Laparoscopic Appendectomy

    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.

    Procedure: Laparoscopic Appendectomy

  • Active comparator
    Group B: Open Appendectomy

    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.

    Procedure: Open Appendectomy

Interventions

  • ProcedureLaparoscopic Appendectomy

    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.

  • ProcedureOpen Appendectomy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days postoperatively

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07879235
Lead sponsor
Assiut University
Responsible party
Ahmed Hassan Mohamed Sleem (Resident, Assiut University) — Principal investigator
First posted
Oct 16, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 16, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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