Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202203884835048 Date of Approval: 28/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Laparoscopic versus open appendectomy in patients with acute appendicitis
Official scientific title Laparoscopic versus open appendectomy in patients with acute appendicitis
Brief summary describing the background and objectives of the trial There were numerous previous studies comparing Open Appendectomy (OA) with Laparoscopic Appendectomy (LA). Although most of these have concluded that the LA is good as OA, there has been considerable controversy as to whether LA is superior to OA or not. The goal of this study was to compare the results of the previous two surgical methods and determine if LA is better than OA.
Type of trial RCT
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 Treatment: Surgery
Anticipated trial start date 06/03/2022
Actual trial start date 06/03/2022
Anticipated date of last follow up 14/05/2022
Actual Last follow-up date 14/03/2022
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group laproscopic appendectomy two week For open appendectomy: Surgery was done using a standard Mc Burney incision. The incision was centered over the point of maximal tenderness (Mc Burney's point). The appendix was delivered and meso-appendix ligated & divided then appendix was ligated and divided at the base. The terminal ileum, ovaries and fallopian tube in females were looked out for any alternative pathology. For laparoscopic appendectomy In our study we used the closed technique by Veress needle to enter the abdomen and create the pneumoperitoneum. Ten mm port is inserted at the umbilicus for the laparoscope. The abdomen was insufflated with CO2 to an intraabdominal pressure of 15mmHg. As insertion of 1st trocar (10 mm) at umbilicus for the camera was done. The second trocar (10 mm) was placed into the left iliac fossa (2 cm above and medial to the left anterior superior iliac spine). The third trocar (5 mm) was put in the suprapubic area (to the left of the midline, 1 cm above the pubic ramus). Diagnostic laparoscopy is recommended prior to proceeding to the appendectomy. Mesoappendix coagulation has been achieved by using the diathermy or harmonic or ligature to extract the mesoappendix. We protect in an extracorporeal way the base of the appendix by pushing a knot pusher across the port at the right-hand side with two successive links of Vicryl 2/0. The appendix is inserted in an extraction sac from the abdomen. The appendix is removed through the umbilical tube. This can be achieved by moving the laparoscope to the suprapubic position and using a claw grasper to grab the Endo bag via the umbilical site. 20
Control Group open appendectomy vs laproscopicappendectomy two weeks For open appendectomy: Surgery was done using a standard Mc Burney incision. The incision was centered over the point of maximal tenderness (Mc Burney's point). The appendix was delivered and meso-appendix ligated & divided then appendix was ligated and divided at the base. The terminal ileum, ovaries and fallopian tube in females were looked out for any alternative pathology. For laparoscopic appendectomy In our study we used the closed technique by Veress needle to enter the abdomen and create the pneumoperitoneum. Ten mm port is inserted at the umbilicus for the laparoscope. The abdomen was insufflated with CO2 to an intraabdominal pressure of 15mmHg. As insertion of 1st trocar (10 mm) at umbilicus for the camera was done. The second trocar (10 mm) was placed into the left iliac fossa (2 cm above and medial to the left anterior superior iliac spine). The third trocar (5 mm) was put in the suprapubic area (to the left of the midline, 1 cm above the pubic ramus). Diagnostic laparoscopy is recommended prior to proceeding to the appendectomy. Mesoappendix coagulation has been achieved by using the diathermy or harmonic or ligature to extract the mesoappendix. We protect in an extracorporeal way the base of the appendix by pushing a knot pusher across the port at the right-hand side with two successive links of Vicryl 2/0. The appendix is inserted in an extraction sac from the abdomen. The appendix is removed through the umbilical tube. This can be achieved by moving the laparoscope to the suprapubic position and using a claw grasper to grab the Endo bag via the umbilical site. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Any patient with came to the emergency unit with clinically suspected acute appendicitis and was above age of 16 years old was enrolled in the study. Both sexes were enrolled in the study. The diagnosis of appendicitis was made on the following criteria: history of right lower quadrant pain or periumbilical pain migrating to the right lower quadrant with nausea and/or vomiting, fever of more than 38°C and/or leukocytosis above 10,000 cells per ml, right lower quadrant guarding, and tenderness on physical examination . Also, by investigations that exclude other causes of acute abdomen. Any patient with an acute Alvarado score of 7 or more was administered 1- Previous abdominal surgery 2- Generalized peritonitis 3- Palpable mass in the right lower quadrant, suggesting an appendiceal abscess or mass 4- Absolute contraindication to laparoscopic surgery (large ventral hernia, history of laparotomies for small bowel obstruction, ascites with abdominal distension) 5- History of cirrhosis and coagulation disorders 6- Pregnancy (except after second trimester). 7- Patient refusal Adult: 19 Year-44 Year 16 Year(s) 60 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
No 14/04/2022 facultyof medicine Alazhar university assiut
Ethics Committee Address
Street address City Postal code Country
assiut st assiut 11751 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome bleeding and hematoma one week
Secondary Outcome wound infection and hernia onemonth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
al azhar univesity hospital assuit branch assuit assuit Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
al Azhar universiy hospitalassiut branch assiut st assiut 71511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor al azhar university hospital assiut branch assiut assiut 71511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator gamal sheemy dr.gamalshemy@gmail.com 01145466512 assiut st
City Postal code Country Position/Affiliation
assiut Egypt consultant
Role Name Email Phone Street address
Public Enquiries mohamed abdelfatah drmohhamedabdelfatah@gmail.com 01157639857 assiut st
City Postal code Country Position/Affiliation
assiut Egypt consultant
Role Name Email Phone Street address
Scientific Enquiries islam aziz islamaziz1088@gmail.com 01009176790 assiut st
City Postal code Country Position/Affiliation
assiut Egypt consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes this will be shared via URL to the published study results within 12 months of finishing the data analysis and the study Clinical Study Report,Statistical Analysis Plan,Study Protocol within 12 months of finishing the data analysis and the study URL sharing
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