Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study
Primary Purpose
Appendicitis Acute
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Open appendectomy
Conventional Lap appendectomy
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis Acute focused on measuring Laparoscopic appendectomy
Eligibility Criteria
Inclusion Criteria: patient age between 5-50 year old patient diagnosed as acute appendicitis Exclusion Criteria: pregnacy perforated appendix severe obese patient previous abdominal exploration
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Open appendectomy
Conventional lap appendectomy
Arm Description
Appendectomy will be done through Mcberney incision.
Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic).
Outcomes
Primary Outcome Measures
Operative time
Time needed for operation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05611489
Brief Title
Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study
Official Title
Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abanoub Atif Fawzy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
laparoscopic versus open appendectomy prospective randomized control study.Both surgical methods are safe and well established in clinical practice but there has been a controversy about which surgical procedure is the most appropriate in this research we are going to demonstrate which operative procedure is more beneficial with less disadvantages.
Detailed Description
A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Using envelopes as an allocation concealment method. Each patient will receive two envelopes one contain paper which determine that patient will have open surgery and the other determine that patient will have lap surgery and neither patient nor experimenters know about them and patient shall choose one of them which will determine what surgery will patient undergo .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute
Keywords
Laparoscopic appendectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
laparoscopic versus open appendectomy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open appendectomy
Arm Type
Other
Arm Description
Appendectomy will be done through Mcberney incision.
Arm Title
Conventional lap appendectomy
Arm Type
Other
Arm Description
Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic).
Intervention Type
Procedure
Intervention Name(s)
Open appendectomy
Intervention Description
performed With the patient in supine position.incision made lateral to McBurney's point.layers of the abdomen is exposed. If the cecum can be visualized, it can be mobilized and used to identify the appendix. Once the appendix is identified, the mesoappendix should be dissected and the appendiceal vessels divided between clamps. The appendiceal vessels are then ligated with silk sutures. A silk purse-string suture can then be placed around the appendiceal base.A 15-blade knife is then used to excise the appendix proximal to the right angle clamp.The appendiceal stump mucosa can be obliterated using electrocautery. Then good haemostasis and layered closure is done.
Intervention Type
Procedure
Intervention Name(s)
Conventional Lap appendectomy
Other Intervention Name(s)
Multiport Lap appendectomy
Intervention Description
Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.
Primary Outcome Measure Information:
Title
Operative time
Description
Time needed for operation
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient age between 5-50 year old
patient diagnosed as acute appendicitis
Exclusion Criteria:
pregnacy
perforated appendix
severe obese patient
previous abdominal exploration
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study
We'll reach out to this number within 24 hrs