Plain English Summary
Background and study aims
Rectal cancer is cancer of the back passage (rectum). Surgery to treat rectal cancer involves the resection (removal) of the rectum and attachment of the colon to the remainder of the rectum (colorectal anastomosis). A conventional ileostomy is usually performed, where the small intestine is diverted through an opening in the abdomen (stoma), which requires a second operation to be closed. The aim of this study is to assess the effectiveness and safety of percutaneous ileostomy by probe, where a tube is inserted into the small intestine which can be removed without a second operation.
Who can participate?
Patients aged over 18 with rectal cancer undergoing surgery
What does the study involve?
Participants are randomly allocated to undergo either conventional ileostomy or percutaneous ileostomy by probe. Anastomotic leakages and complications due to the placement and removal of the probe are assessed.
What are the possible benefits and risks of participating?
Percutaneous ileostomy by probe may be more comfortable than conventional ileostomy and doesn't require another operation to be removed. The risk is that percutaneous ileostomy by probe leads to anastomotic leakages and peritonitis (inflammation of the lining of the abdomen).
Where is the study run from?
Ospedale San Giovanni Battista (Italy)
When is the study starting and how long is it expected to run for?
February 2012 to December 2015
Who is funding the study?
Umbria Local Health Office No.3 (Italy)
Who is the main contact?
Dr Enrico Mariani
enrico.mariani@yahoo.it
Trial website
Contact information
Type
Scientific
Primary contact
Dr Enrico Mariani
ORCID ID
Contact details
S.C. Chirurgia Generale
Ospedale San Giovanni Battista
Via Arcamone
Foligno
06034
Italy
+39 (0)7 42 3391
enrico.mariani@yahoo.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RO-MA 01 N.28657/1/AV
Study information
Scientific title
Traditional lateral ileostomy vs percutaneous ileostomy by exclusion probe for the protection of the extraperitoneal colo-rectal anastomosis (Ileostomia laterale tradizionale vs ileostomia percutanea escludente su sonda dedicata a protezione della anastomosi colorettali extraperitoneali): the ALPPI (Anastomotic Leak Prevention by Probe Ileostomy) trial
Acronym
ALPPI
Study hypothesis
Percutaneous ileostomy is safe and effective in protecting low colo-rectal anastomosis as lateral conventional ileostomy, and it is well tolerated and it doesn't need another surgical procedure for the closure.
Ethics approval
Ethics Commitee of Regional Public Health System of Umbria, 15/09/2011, Protocol Number 28657/11/AV
Study design
Multicentre open randomized parallel-group study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Colorectal cancer
Intervention
The comparison of two different ileostomy: conventional lateral ileostomy vs percutaneous ileostomy by probe
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
The protection of the extraperitoneal colo-rectal anastomosis in term of asymptomatic or symptomatic leakage
Secondary outcome measures
1. The evaluation of any local complications due to the probe removal
2. Short and long-term general complications
Overall trial start date
20/02/2012
Overall trial end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age >= 18 years
2. Elective surgery (prepared colon or rectum)
3. Neoplastic disease of the colon-rectum
4. Approved informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200 (100 per arm)
Participant exclusion criteria
1. Age< 18 years
2. Emergency surgery (prepared colon or rectum)
3. Pregnancy or breastfeeding in course
4. Indications for another type of surgery different from the neoplastic disease
5. Inflammatory bowel diseases
6. Refusal to provide informed consent
Recruitment start date
20/02/2012
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Italy
Trial participating centre
Ospedale San Giovanni Battista
Foligno
06034
Italy
Sponsor information
Organisation
Umbria Local Health Office No.3 (Azienda Sanitaria Locale N. 3 dell Umbria) (Italy)
Sponsor details
Piazza Giacomini
40
Foligno (Perugia)
06034
Italy
+39 (0)7 423 391
enrico.mariani@yahoo.it
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Umbria Local Health Office No.3 (Azienda Sanitaria Locale N.3, Umbria) (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24491287
Publication citations
-
Results
Bugiantella W, Rondelli F, Mariani L, Boni M, Tassi A, Stella P, Patiti M, Ermili F, Avenia N, Mariani E, Traditional lateral ileostomy versus percutaneous ileostomy by exclusion probe for the protection of extraperitoneal colo-rectal anastomosis: the ALPPI (Anastomotic Leak Prevention by Probe Ileostomy) trial. A randomized controlled trial., Eur J Surg Oncol, 2014, 40, 4, 476-483, doi: 10.1016/j.ejso.2013.12.025.