Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05442333 |
| Other study ID # |
ziad khaled |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
June 2023 |
Study information
| Verified date |
May 2023 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Extremity soft tissue sarcomas (ESTS)s are rare mesenchymal cancers that considered a
challenge for orthopaedic surgeons. Soft tissue sarcomas (STS) comprise less than 1% of
malignant cancers, commonly occur in the proximal extremities and trunk. Limb-sparing surgery
mostly are targeted in most of the patients, so adjuvant or neoadjuvant radiotherapy is
usually added. Preoperative radiotherapy (neoadjuvant) or postoperative radiotherapy
(adjuvant) offers local control and survival rates, but the local complications are
controversial. However, different retrospective studies had shown that preoperative
radiotherapy cause higher wound complication rate, while both preoperative and postoperative
radiotherapy had the same results regarding local recurrence
Description:
Study Tools :The patients will be managed as follows:
Primary (Preoperative) Diagnosis and Evaluation
Clinical Evaluation. History. General examination. Local examination.
Radiological Evaluation:
Plain X-ray for the affected limb to determine presence of any bone affection or invasion.
Preoperative MRI scan to determine the extent of soft tissue, bone and neurovascular bundle
invasion.
Preoperative bone scan to determine skeletal metastatic load.
Perioperative protocol:
Preoperative radiotherapy 3-6 weeks before surgical excision. Postoperative radiotherapy 3- 6
weeks or more after surgical excision Tissue diagnosis will be obtained.
Operative management:
Surgical excision of whole tumour with wide safety margin.
Data collection:
Patient demographics (age, sex). Activity level Primary sarcoma type Patient comorbidities
Timing of Preoperative radiotherapy if present. Timing of Postoperative radiotherapy if
present. Time from diagnosis to surgery. recurrence Operative time (minutes) measured from
skin incision to wound closure. Follow up regarding wound complications, local recurrence or
infection. local recurrence will be followed up till the end of the study
Follow up strategy:
The patients with preoperative radiotherapy:
will be assessed 2 weeks postoperative regarding wound signs of infection (redness, hotness
or discharge).
1 month postoperatively for wound complete closure and exclude signs of infection.
3 months postoperatively for wound dehiscence, swelling or local recurrence. 6 months
postoperatively for local recurrence, pathological fractures or joint stiffness
The patients with postoperative radiotherapy:
will be assessed 3 weeks post radiation regarding wound signs of infection (redness, hotness
or discharge).
6 weeks post radiation for wound dehiscence 3 months post radiation for local swelling or
recurrence 6 months post radiation for local recurrence, joint stiffness or pathological
fractures.
Statistical Analysis: Statistical package for social science (SPSS 15.0.1 for windows ; 〖SPSS
Inc,Chicago,IL,2001). Data will be presented as Mean and Standard deviation ( +/-SD) for
quantitative parametric data , and Median and Interquartile range for quantitative non
parametric data. Frequency and percentage will be used for presenting qualitative data.
Suitable analysis will be done according to the type of data obtained. P<0.05 will be
considered significant.
Statistical Package: data entry and statistical analysis of the collected data will be
performed using reliable software program.
