Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study

Appendicitis Acute Clinical Trial

Official title:

Laparoscopic Versus Open Appendectomy Prospective Randomized Control Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05611489
• Other study ID #: Laparoscopic appendectomy
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: November 2024

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: November 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abanoub Atif Fawzy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Time needed for operation	1 year