Abdomen CT and Open Appendicectomy：New Diagnostic and Surgical Procedures (ACAOA)

October 9, 2015 updated by: weng xinhai, Ningbo Municipal No.4 Hospital

The traditional open appendectomy in the clinical effect is not prefect, and for a long time there is no measurable improvement. The application of abdomen CT before surgery provides a new approach to the incision and new perception.

In a randomized controlled trial of modified incision versus traditional incision. Length of hospital day was the primary terminus, while operating time, postoperative complication, scar and time to resume normal activity and work as secondary terminus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Traditional open appendicectomy have many drawbacks, such as false-positive, cut infection, scar, extended cut, slower rehabilitation and return to work. In the past few years, in order to improve diagnostic accuracy, the abdomen CT is been general applied before appendicectomy, in addition to, a modified incision (MI) was designed based on it. Using a MI compare traditional incision (TI) to the patient including cut extended, operating time, cut infection, false-positive rate, rehabilitation and return to work. It seems that MI would prove superior to TI in terms of hospital day (primary terminus), with operating time, postoperative complication, scar and time to resume normal activity and work as secondary terminus.

Study Type

Interventional

Enrollment (Actual)

730

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with a clinical diagnosis of acute appendicitis

Exclusion Criteria:

  • children under 14 are not included

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: traditional incision
traditional incision : McBurney incision,Rectus incision,Appendix Transverse incision or Tenderness point incision,it was invaginated at the discretion of the surgeon.
Other: traditional incision
McBurney incision,Rectus incision,Appendix Transverse incision or Tenderness point incision,it was invaginated at the discretion of the surgeon.
Experimental: modified incision
modified incision :The application of abdomen CT before surgery provides a new approach to the incision and new perception.
Radiation: The application of abdomen CT
A modified incision(MI)was designed based on abdomen CT.Using a MI compare traditional incision(TI) to the patient including cut extended, operating time,cut infection, false-positive rate,rehabilitation and return to work.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hospital day
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
time to return to normal activity and work in days
Time Frame: up to 4 weeks
up to 4 weeks
operating time in minutes
Time Frame: 180 Minutes
180 Minutes
numbers of extended cut, numbers of infection,numbers of intraperitoneal abscess
Time Frame: 1 weeks
1 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ningbo Municipal No.4 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 9, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • wxinhai

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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