Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate Laparoscopic Appendectomy

    Procedure/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 Appendectomy

    Procedure/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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group A: Immediate Laparoscopic AppendectomyExperimental treatment 1 intervention
Group B: Group B: Interval Laparoscopic AppendectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total Length of Hospital Stay

Time frame
Up to 3 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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