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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02574364
Other study ID # wxinhai
Secondary ID
Status Completed
Phase N/A
First received September 29, 2015
Last updated October 9, 2015
Start date July 2013
Est. completion date April 2015

Study information

Verified date October 2015
Source Ningbo Municipal No.4 Hospital
Contact n/a
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Zhejiang Province
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 730
Est. completion date April 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility Inclusion Criteria:

- patients with a clinical diagnosis of acute appendicitis

Exclusion Criteria:

- children under 14 are not included

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ningbo Municipal No.4 Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary hospital day 2 weeks Yes
Secondary time to return to normal activity and work in days up to 4 weeks Yes
Secondary operating time in minutes 180 Minutes Yes
Secondary numbers of extended cut, numbers of infection,numbers of intraperitoneal abscess 1 weeks Yes
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