Abdomen CT and Open Appendicectomy：New Diagnostic and Surgical Procedures

NCT ID: NCT02574364

Last Updated: 2015-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 730 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-04-30

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.

Conditions

Wound Infection; Complication; Scar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

traditional incision

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

Group Type: ACTIVE_COMPARATOR

traditional incision

Intervention Type: OTHER

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

modified incision

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

Group Type: EXPERIMENTAL

The application of abdomen CT

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

traditional incision

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients with a clinical diagnosis of acute appendicitis

Exclusion Criteria

• children under 14 are not included

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo Municipal No.4 Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

weng xinhai

attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

wxinhai

Identifier Type: -

Identifier Source: org_study_id