Abdomen CT and Open Appendicectomy：New Diagnostic and Surgical Procedures

Wound Infection Clinical Trial

— ACAOA  

Official title:

Abdomen CT and Open Appendicectomy：New Diagnostic and Surgical Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574364
• Other study ID #: wxinhai
• 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

• Complication
• Scar
• Wound Infection

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