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

Primary Purpose

Wound Infection, Complication, Scar

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

The application of abdomen CT

traditional incision

About this trial

This is an interventional treatment trial for Wound Infection focused on measuring abdomen CT, open appendicectomy

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients with a clinical diagnosis of acute appendicitis

Exclusion Criteria:

children under 14 are not included

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

traditional incision

modified incision

Arm Description

traditional incision : McBurney incision,Rectus incision,Appendix Transverse incision or Tenderness point incision,it was invaginated at the discretion of the surgeon.

modified incision :The application of abdomen CT before surgery provides a new approach to the incision and new perception.

Outcomes

Primary Outcome Measures

hospital day

Secondary Outcome Measures

time to return to normal activity and work in days

operating time in minutes

numbers of extended cut, numbers of infection,numbers of intraperitoneal abscess

Full Information

NCT ID

NCT02574364

First Posted

September 29, 2015

Last Updated

October 9, 2015

Sponsor

Ningbo Municipal No.4 Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02574364

Brief Title

Abdomen CT and Open Appendicectomy：New Diagnostic and Surgical Procedures

Acronym

ACAOA

Official Title

Abdomen CT and Open Appendicectomy：New Diagnostic and Surgical Procedures

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ningbo Municipal No.4 Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Infection, Complication, Scar

Keywords

abdomen CT, open appendicectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

730 (Actual)

8. Arms, Groups, and Interventions

Arm Title

traditional incision

Arm Type

Active Comparator

Arm Description

traditional incision : McBurney incision,Rectus incision,Appendix Transverse incision or Tenderness point incision,it was invaginated at the discretion of the surgeon.

Arm Title

modified incision

Arm Type

Experimental

Arm Description

modified incision :The application of abdomen CT before surgery provides a new approach to the incision and new perception.

Intervention Type

Radiation

Intervention Name(s)

The application of abdomen CT

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

traditional incision

Intervention Description

McBurney incision,Rectus incision,Appendix Transverse incision or Tenderness point incision,it was invaginated at the discretion of the surgeon.

Primary Outcome Measure Information:

Title

hospital day

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

time to return to normal activity and work in days

Time Frame

up to 4 weeks

Title

operating time in minutes

Time Frame

180 Minutes

Title

numbers of extended cut, numbers of infection,numbers of intraperitoneal abscess

Time Frame

1 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients with a clinical diagnosis of acute appendicitis Exclusion Criteria: children under 14 are not included

12. IPD Sharing Statement

Learn more about this trial

Abdomen CT and Open Appendicectomy：New Diagnostic and Surgical Procedures

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