Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000835842
Ethics application status
Approved
Date submitted
4/08/2012
Date registered
8/08/2012
Date last updated
28/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Proctectomy with sphincter preservation in very low rectal cancer that traditionally need abdominoperineal resection with permanent colostomy
Scientific title
Effect of changing decision of abdominoperineal resection to sphincter preserving technique in very low rectal cancer after downstaging by neoadjuvant chemoradiation on recurrence and survival
Secondary ID [1] 280974 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low rectal cancer 287086 0
Condition category
Condition code
Surgery 287414 287414 0 0
Surgical techniques
Cancer 287434 287434 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with stage II and III low rectal cancer less than 5 cm from anal verge usually need abdominoperineal resection. Preoperative neoadjuvant chemoradiation(54 grays of radiation divided over 5 weeks with chemotherapy by intravenous 5-fu and leucovorin 1 day a week for 5 weeks; 5-FU 425 mg/m2 plus LV 45 mg ) helps in tumor downstaging and downsizing that might help to resect the tumor with safety margin without removing the anal sphincters. Patients with T3, T4 low rectal tumors 5 cm or less from anal verge receive neoadjuvant preoperative chemoradiation. Patient assessment is done 8 weeks after the end of chemoradiation by digital rectal examination and endorectal ultrasound. If there is tumor downsizing that leaves safety margin above the anal sphincters, , then very low anterior resection with coloanal anastomosis is performed (120-180 minutes) . If no sufficient safety margin, intersphincteric resection (120-180 minutes) with coloanal anastomosis is done if the external anal sphincter is not involved (yT2), if the external sphincter was involved so abdominoperineal resection is done and excluded from study.
Intervention code [1] 285420 0
Treatment: Surgery
Intervention code [2] 285432 0
Treatment: Drugs
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287677 0
Perioperative morbidity assesed by clinical examination of the abdomen to diagnose wound problems, chest x ray and Ultrasound abdomen
Timepoint [1] 287677 0
1-30 days postoperative
Primary outcome [2] 287678 0
Perioperative mortailty
Timepoint [2] 287678 0
1-30 days postoperative
Primary outcome [3] 287679 0
Tumor recurrence assessed by clinical examination and abdominal CT scan
Timepoint [3] 287679 0
every 6 months postoperative for 2 years
Secondary outcome [1] 298621 0
Morbidity and mortality after salvage surgery in case of recurrence by clinical examination of the abdomen to diagnose wound problems, chest x ray and Ultrasound abdomen
Timepoint [1] 298621 0
1-30 days postoperative after salvage surgery
Secondary outcome [2] 298654 0
Continence assessed by wexner score
Timepoint [2] 298654 0
6 months and 1 year postoperative

Eligibility
Key inclusion criteria
Adult male or female 18-80 years
low rectal tumor, 5 cm or less from anal verge
Stage II or III
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stage IV tumors
fecal incontinence assessed by wexner score

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/01/2007
Actual
20/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 4460 0
Egypt
State/province [1] 4460 0

Funding & Sponsors
Funding source category [1] 285756 0
Self funded/Unfunded
Name [1] 285756 0
Country [1] 285756 0
Egypt
Primary sponsor type
Individual
Name
Khaled Madbouly
Address
Kolet el teb street, Azarita, Faculty of medicine, university of alexandria, Alexandria, 21321, egypt
Country
Egypt
Secondary sponsor category [1] 284586 0
None
Name [1] 284586 0
Address [1] 284586 0
Country [1] 284586 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287769 0
Ethics Committee, University of Alexandria
Ethics committee address [1] 287769 0
Ethics committee country [1] 287769 0
Egypt
Date submitted for ethics approval [1] 287769 0
Approval date [1] 287769 0
Ethics approval number [1] 287769 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34538 0
A/Prof Khaled Madbouly
Address 34538 0
Faculty of Medicine, University of Alexandria. Kolet el teb Street, Azarita, Alexandria. 21321
Country 34538 0
Egypt
Phone 34538 0
+2034802375
Fax 34538 0
Email 34538 0
[email protected]
Contact person for public queries
Name 17785 0
Khaled Madbouly
Address 17785 0
Kolet el teb street, Azarita, Faculty of medicine, university of alexandria, Alexandria, 21321, egypt
Country 17785 0
Egypt
Phone 17785 0
+20 34802375
Fax 17785 0
Email 17785 0
[email protected]
Contact person for scientific queries
Name 8713 0
Khaled Madbouly
Address 8713 0
Kolet el teb street, Azarita, Faculty of medicine, university of alexandria, Alexandria, 21321, egypt
Country 8713 0
Egypt
Phone 8713 0
+20 34802375
Fax 8713 0
Email 8713 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.