Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508653883543 Date of Registration: 01/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Laparoscopic appendectomy: appropriateness and feasibility
Official scientific title Laparoscopic appendectomy: appropriateness and feasibility
Brief summary describing the background and objectives of the trial Acute appendicitis is considered one of the most common abdominal crises globally. The reason remains poorly known, with limited breakthroughs in the recent decades Perforation incidence is associated with a late diagnosis and age of the patients. After the year 2000, the negative appendectomy rate has decreased, although the rates for perforated appendicitis appear to be growing. The periumbilical pain spreading to the right lower abdominal quadrant is considered diagnostic of acute appendicitis. A similar pain occurring in women of childbearing age must be differentiated from the appendicitis pain as the gynecologic illnesses may appear similar to the appendicitis. Because of its high morbidity rate, appendicitis requires early and correct diagnosis before perforation occurs. The choice of the right treatment (surgical or nonsurgical) depends upon the pathologic stage of appendicitis. These reatment options include open or laparoscopic appendectomy, initiating antibiotic therapy, or percutaneous drainage of periappendiceal abscesses. Obtaining a solid preoperative diagnosis remains difficult because the likelihood of appendicitis must be considered in each patient showing an acute abdomen. Although laboratory tests and imaging are useful aids to history and examination, their limitations ensure that the clinical evaluation remains the main way of diagnosis. A clinical classification is used to stratify management based on whether the appendix is perforated or not, but many patients still have an ambiguous diagnosis, which is one of the most difficult challenges. This study aimed to evaluate the appropriateness and feasibility of Laparoscopic appendectomy (LA) by comparing postoperative outcomes, including complications, pain, and recovery, against conventional open appendectomy.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 05/06/2018
Actual trial start date 05/06/2018
Anticipated date of last follow up 08/04/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Laparoscopic appendictomy once duration of the operation three ports are utilized to insert equipment into the abdominal cavity. The laparoscope is put into the umbilicus, and pneumoperitoneum develops; the location of the other two trocars for surgical equipment varies depending on the surgeon's choice and skill. Trocars were placed in the infraumbilical + suprapubic + Left Lower Quadrant. The trocars were inserted in accordance with the triangulation rule, with the appendix at the apex of a triangle. The umbilical port is 5-12 mm in diameter, while the others are normally 5 mm in size. During the surgical process, numerous approaches were employed for cutting and extracting the appendix, as well as to achieve adequate hemostasis; nevertheless, peritoneal drainage and irrigation should not be performed routinely. The "puppeteer technique" reduces the number of trocars to two; in this form, the appendix is suspended with transabdominal threads. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with acute appendicitis, whatever the evolutionary stage of appendicitis Perforated appendicitis with diffuse peritonitis Appendicular mass or abscess Critically ill or unstable patients Previous extensive abdominal surgeries Pregnancy (especially 3rd trimester) Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/06/2018 Faculty of Medicine Al Azhar University Assiut
Ethics Committee Address
Street address City Postal code Country
Al Azhar University Assiut Assiut 71511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative Complication Rate, Length of Hospital Stay daily postoperative till discharge from hospital
Secondary Outcome Time to Return to Normal Activities or Work, Postoperative Pain Score first, second, and third day postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Orthopedic and Traumatology department Al Azhar University Hospital Assiuta Al Azhar University Hospitals Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Al Azhar University Hospital Assiut Al Azhar University Hospital Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar University hospital Al Azhar University hospital assiut Assiut Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mohamed Nabih.m.2025@outlook.com +201067505327 General hospital Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Resident of General surgery
Role Name Email Phone Street address
Public Enquiries Adel Mohamed adel.m.khalaf@gmail.com +201001828776 AlAzhar University hospital Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Assistant Professor of general surgery Faculty of Medicine Al Azhar university Assiut
Role Name Email Phone Street address
Scientific Enquiries Amer Mohamed Amer_Yehia2002@yahoo.com +201009095740 AlAzhar University hospital Assiut
City Postal code Country Position/Affiliation
Assiut Egypt Professor of Orthopedic and Traumatology Al Azhar University Assiut
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that underlie the results of this study will be available after deidentification (text, tables, figures) Clinical Study Report,Informed Consent Form,Study Protocol data will be available 3 months and up to 12 months after article publications qualified persons only
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 01/08/2025 PACTR Admin 05 Jun 2018