search
Back to results

Open to Laparoscopic Reverse Conversion of Perforated Appendicitis (reverse)

Primary Purpose

Laparoscopic Surgery, Acute Appendicitis With Rupture, Sepsis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
reverse conversion technique
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Surgery focused on measuring laparoscopic, appendectomy, reverse conversion, reoperation, intraabdominal abscesses

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Zagazig University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

group A

group B

Arm Description

the group who was subjected to the reverse conversion technique

the control group who was completed by open technique

Outcomes

Primary Outcome Measures

the rates of intraabdominal abscess
rates of complications
rates of wound infection
rates of complications
rates of ileus
rates of reoperation

Secondary Outcome Measures

The hospital length of stay
the length of hospital stay
the operative time
Time of performing the procedures

Full Information

First Posted
February 18, 2022
Last Updated
March 16, 2022
Sponsor
Zagazig University
search

1. Study Identification

Unique Protocol Identification Number
NCT05283733
Brief Title
Open to Laparoscopic Reverse Conversion of Perforated Appendicitis
Acronym
reverse
Official Title
A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in Management of Acute Perforated Appendicitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in management of Acute Perforated Appendicitis
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Surgery, Acute Appendicitis With Rupture, Sepsis, Abdominal Abscess
Keywords
laparoscopic, appendectomy, reverse conversion, reoperation, intraabdominal abscesses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
426 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
the group who was subjected to the reverse conversion technique
Arm Title
group B
Arm Type
No Intervention
Arm Description
the control group who was completed by open technique
Intervention Type
Procedure
Intervention Name(s)
reverse conversion technique
Other Intervention Name(s)
laparoscopic lavage
Intervention Description
converting open appendectomy to laparoscopic technique for proper control of intraabdominal sepsis
Primary Outcome Measure Information:
Title
the rates of intraabdominal abscess
Description
rates of complications
Time Frame
3 months post operative
Title
rates of wound infection
Description
rates of complications
Time Frame
3 months post operative
Title
rates of ileus
Time Frame
Baseline (Hospital admission)
Title
rates of reoperation
Time Frame
3 months post operative
Secondary Outcome Measure Information:
Title
The hospital length of stay
Description
the length of hospital stay
Time Frame
up to 3 months
Title
the operative time
Description
Time of performing the procedures
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Facility Information:
Facility Name
Zagazig University
City
Zagazig
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Open to Laparoscopic Reverse Conversion of Perforated Appendicitis

We'll reach out to this number within 24 hrs