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