NCT05611489

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

Same day

First QC Date

November 1, 2022

Last Update Submit

July 14, 2023

Conditions

Keywords

Laparoscopic appendectomy

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Time needed for operation

    1 year

Study Arms (2)

Open appendectomy

OTHER

Appendectomy will be done through Mcberney incision.

Procedure: Open appendectomy

Conventional lap appendectomy

OTHER

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

Interventions

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.

Open 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.

Also known as: Multiport Lap appendectomy
Conventional lap appendectomy

Eligibility Criteria

Age5 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patient age between 5-50 year old
  • patient diagnosed as acute appendicitis

You may not qualify if:

  • pregnacy
  • perforated appendix
  • severe obese patient
  • previous abdominal exploration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: laparoscopic versus open appendectomy
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 10, 2022

Study Start

November 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2024

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share