NCT06897709

Brief Summary

Objective: This study aims to compare the standard laparoscopic appendectomy with the "Stump-First Approach" technique in patients diagnosed with acute appendicitis in terms of intraoperative and postoperative complications that may occur (injury, intra-abdominal abscess, postoperative fever, and infection parameters).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

February 5, 2025

Last Update Submit

March 25, 2025

Conditions

Keywords

appendectomylaparoscopic appendectomysurgical tecnic

Outcome Measures

Primary Outcomes (1)

  • The number of participants compared in infection status

    The groups were compared in infection status (WBC, CRP, additional antibiotic requirements)

    1 year

Study Arms (2)

Group 1: underwent laparoscopic appendectomy using the standard approach

ACTIVE COMPARATOR

In Group 1, as part of the standard approach, the mesoappendix was initially ligated using LigaSure. After visualizing the base of the appendix, two hemoclips were applied on the stump side and one hemoclip on the appendix side. The tissue between was then divided with scissors, and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag.

Procedure: Classic Approach in Laparoscopic Appendectomy

Group 2 underwent laparoscopic appendectomy using the Stump-First Approach

ACTIVE COMPARATOR

Group 2, the cecal appendix was identified, and a window was created at the base of the appendix between the mesoappendix and the appendiceal wall. Two hemoclips were applied on the stump side, and one hemoclip on the appendix side. The tissue between was then divided with scissors. Finally, the mesoappendix was divided using LigaSure and the appendix was removed from the abdomen through the trocar in the umbilicus within an endobag

Procedure: Stump first Approach in Laparoscopic Appendectomy

Interventions

underwent laparoscopic appendectomy using the standard approach

Group 1: underwent laparoscopic appendectomy using the standard approach

Stump first Approach in Laparoscopic Appendectomy

Group 2 underwent laparoscopic appendectomy using the Stump-First Approach

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute appendicitis

You may not qualify if:

  • exist of pregnancy, exist of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir City Hospital

Izmir, Turkey (Türkiye)

Location

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
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asosc. prof

Study Record Dates

First Submitted

February 5, 2025

First Posted

March 27, 2025

Study Start

April 1, 2023

Primary Completion

May 15, 2024

Study Completion

May 15, 2024

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations