NCT06158308

Brief Summary

Background: Laparoscopic appendectomy as a minimal invasive procedure had low morbidity and mortality. It affords a direct diagnosis of the problem, allows determination of the appropriate treatment. Open appendectomy is global treatment of acute appendicitis can be done by many incisions, and associated with considerable complications. Materials and Methods: This is a cross sectional descriptive hospital-based study to study the outcome of laparoscopic appendectomy versus open appendectomy at Elmak Nimer University Hospital over the study period. All patients in the study period who underwent appendectomy was included, data is collected through standard structured data collection sheet and analyzed by using SPSS v24.0.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2021

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
Last Updated

December 6, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 18, 2023

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The rate of post-operative complications

    the rate of postoperative complications, such as surgical site infections, intra-abdominal abscess formation, and other adverse events. The comparison would help assess the efficacy and safety of each surgical approach in the context of appendectomies.

    Jan 2019 - Jan 2021

Study Arms (2)

Laparoscopic Appendicectomy

Procedure: Laproscopic Appendicectomy

Open Appendicectomy

Procedure: Open Appendicectomy

Interventions

A type of surgery done without a large incision. Instead, from 1 to 3 tiny cuts are made. A long, thin tube called a laparoscope is put into one of the incisions. It has a tiny video camera and surgical tools.

Also known as: Regular surgical site dressing
Laparoscopic Appendicectomy

A cut or incision about 2 to 4 inches long is made in the lower right-hand side of your belly or abdomen. The appendix is taken out through the incision.

Also known as: Regular surgical site dressing
Open Appendicectomy

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study includes all patients those underwent appendectomy during the study period.

You may qualify if:

  • All patients in the study period who underwent appendectomy were included.

You may not qualify if:

  • Patientspresented with complicated appendicitis
  • Acute appendicitis with comorbiditites
  • Pregnant ladies
  • Patients of stump appendicitis .
  • Patient with inadequate data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine, Elmak Nemir University

Shandi, Alnahr Alabyad, 00000, Sudan

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2023

First Posted

December 6, 2023

Study Start

January 13, 2019

Primary Completion

January 1, 2021

Study Completion

January 10, 2021

Last Updated

December 6, 2023

Record last verified: 2023-11

Locations