ClinicalTrials.gg
CompletedNCT05283733reverseUpdated Mar 17, 2022

Open to Laparoscopic Reverse Conversion of Perforated Appendicitis

An interventional study of reverse conversion technique in Laparoscopic Surgery, Acute Appendicitis With Rupture and Sepsis, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-17.

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

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Jan 2018, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
426
Allocation
Randomized
Ages
16 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Laparoscopic Surgery
  • Acute Appendicitis With Rupture
  • Sepsis
  • Abdominal Abscess

Keywords

  • laparoscopic
  • appendectomy
  • reverse conversion
  • reoperation
  • intraabdominal abscesses
03

In context

Sepsis

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's enrollment of 426 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Zagazig University is the lead sponsor of 459 studies on the registry; 77 are open to participants now.

Of its 5 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
16 Years to 65 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

  • symptoms consistent with acute perforated appendicitis,
  • had ultrasound or computed tomography (CT) evidence of acute perforated appendicitis,
  • ages ranging from 16 to 65 years.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
426 participants (actual)

Study arms

  • Experimental
    group A

    the group who was subjected to the reverse conversion technique

    Procedure: reverse conversion technique

  • No intervention
    group B

    the control group who was completed by open technique

Interventions

  • Procedurereverse conversion technique

    converting open appendectomy to laparoscopic technique for proper control of intraabdominal sepsis

    Also known as: laparoscopic lavage

06

What researchers measure

Primary outcomes

  1. the rates of intraabdominal abscess

    rates of complications

    Time frame: 3 months post operative

  2. rates of wound infection

    rates of complications

    Time frame: 3 months post operative

  3. rates of ileus

    Time frame: Baseline (Hospital admission)

  4. rates of reoperation

    Time frame: 3 months post operative

Secondary outcomes

  1. The hospital length of stay

    the length of hospital stay

    Time frame: up to 3 months

  2. the operative time

    Time of performing the procedures

    Time frame: Intraoperative

07

Study locations

1 site
  • Zagazig University
    Zagazig, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05283733
Lead sponsor
Zagazig University
Responsible party
Mohamed lotfy (Associate professor, Zagazig University) — Principal investigator
First posted
Mar 17, 2022
Start date
Jan 18, 2018
Primary completion
Dec 15, 2021
Completion
Dec 25, 2021
Last update
Mar 17, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion