NCT03930667

Brief Summary

Aimed to the study evaluate the superiority of intracorporal sutures and Hem-o-lok clips in terms of efficiency.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

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

March 25, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

3.4 years

First QC Date

April 21, 2019

Last Update Submit

April 27, 2019

Conditions

Appendicitis, Surgery

Keywords

Appendicitis; Laparoscopic Surgery; Cost Effectiveness

Outcome Measures

Primary Outcomes (1)

  • cost effectiveness

    cost of treatment from surgery to discharge

    4 years

Study Arms (2)

clips

ACTIVE COMPARATOR

Closure of the appendix stump with hem-o-lok clips

Procedure: clips

knotting

EXPERIMENTAL

Closure of the appendix stump with intracorporal knotting.

Procedure: knotting

Interventions

clipsPROCEDURE
clips
knottingPROCEDURE
knotting

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of acute appendicitis

You may not qualify if:

  • under 18 years of age
  • other patology in addition to appendiceal pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Appendicitis

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Orhan Ureyen

    Health Sciences University, İzmir Bozyaka Training and Research Hospital, General Surgery Department, Izmir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical expert in General Surgery,Principal Investigator

Study Record Dates

First Submitted

April 21, 2019

First Posted

April 29, 2019

Study Start

March 25, 2015

Primary Completion

August 1, 2018

Study Completion

December 31, 2018

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
2015-2019