NCT01260064

Brief Summary

1\. Laparoscopic appendectomy may not be a superior procedure when compared with open appendectomy; 2. Various modifications in laparoscopic appendectomy procedure may reduce the technical diffuculty and overall costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable

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

October 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 26, 2011

Status Verified

May 1, 2011

Enrollment Period

6 months

First QC Date

December 13, 2010

Last Update Submit

May 25, 2011

Conditions

Appendicitis

Keywords

AppendicitisOpen appendectomyLaparoscopic appendectomyEndoclipIntracorporeal sutureQuality-of-life

Outcome Measures

Primary Outcomes (1)

  • Quality of life.

    Quality of life after various appendectomy procedures will be measured by a spesific quality-of-life index.

    1 month

Secondary Outcomes (1)

  • Cost-effectivity

    1 month

Study Arms (3)

Open appendectomy

ACTIVE COMPARATOR

The subjects will have open appendectomy procedure.

Procedure: Open appendectomy

Metal endoclip

ACTIVE COMPARATOR

The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.

Procedure: Laparoscopic appendectomy with metal endoclips

Intracorporeal suture ligation

ACTIVE COMPARATOR

The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.

Procedure: Laparoscopic appendectomy with suture ligation

Interventions

Open appendectomyPROCEDURE

The subjects will have traditional open appendectomy procedure.

Also known as: Open technique
Open appendectomy
Laparoscopic appendectomy with metal endoclipsPROCEDURE

The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.

Also known as: Metal endoclip
Metal endoclip
Laparoscopic appendectomy with suture ligationPROCEDURE

The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.

Also known as: Intracorporeal suture ligation
Intracorporeal suture ligation

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patients with a preoperative diagnosis of acute appendicitis

You may not qualify if:

  • The patients who are not volunteered to join the study
  • The patients who are diagnosed to have peroperative or histopathological pathology other than acute appendicitis
  • The patients who have additional pathologies accompanying acute appendicitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Sadi Konuk Training and Research Hospital

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Open Abdomen Techniques

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Abdominal Wound Closure TechniquesWound Closure TechniquesSurgical Procedures, Operative

Study Officials

  • Halil Alis, MD

    Dr. Sadi Konuk Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 13, 2010

First Posted

December 15, 2010

Study Start

October 1, 2010

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

May 26, 2011

Record last verified: 2011-05

Locations

TU(1)