Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Appendicitis Acute
• Intervention / Treatment: Procedure: Conventional Lap appendectomy; Procedure: Open appendectomy

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 .

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. patient age between 5-50 year old
2. patient diagnosed as acute appendicitis

Exclusion Criteria:

1. pregnacy
2. perforated appendix
3. severe obese patient
4. previous abdominal exploration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Conventional lap appendectomy; 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).	Procedure: Conventional Lap appendectomy; 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.; Other Names: Multiport Lap appendectomy
Other: Open appendectomy; Appendectomy will be done through Mcberney incision.	Procedure: Open appendectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Time needed for operation	1 year

Collaborators and Investigators

• Sponsor: Abanoub Atif Fawzy

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Laparoscopic appendectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: Laparoscopic appendectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No