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)

ISRCTN	ISRCTN99356919
DOI	https://doi.org/10.1186/ISRCTN99356919
Secondary identifying numbers	RO-MA 01 N.28657/1/AV

Submission date: 19/02/2012
Registration date: 02/05/2012
Last edited: 20/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Enrico Mariani
Scientific

S.C. Chirurgia Generale
Ospedale San Giovanni Battista
Via Arcamone
Foligno
06034
Italy

Phone	+39 (0)7 42 3391
Email	enrico.mariani@yahoo.it

Study information

Study design	Multicentre open randomized parallel-group study
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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
Study acronym	ALPPI
Study objectives	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(s)	Ethics Commitee of Regional Public Health System of Umbria, 15/09/2011, Protocol Number 28657/11/AV
Health condition(s) or problem(s) studied	Colorectal cancer
Intervention	The comparison of two different ileostomy: conventional lateral ileostomy vs percutaneous ileostomy by probe
Intervention type	Procedure/Surgery
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 study start date	20/02/2012
Completion date	31/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200 (100 per arm)
Key inclusion criteria	1. Age >= 18 years 2. Elective surgery (prepared colon or rectum) 3. Neoplastic disease of the colon-rectum 4. Approved informed consent
Key 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
Date of first enrolment	20/02/2012
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

Italy

Study participating centre

Ospedale San Giovanni Battista

Foligno
06034
Italy

Sponsor information

Umbria Local Health Office No.3 (Azienda Sanitaria Locale N. 3 dell Umbria) (Italy)
Government

Piazza Giacomini, 40
Foligno (Perugia)
06034
Italy

Phone	+39 (0)7 423 391
Email	enrico.mariani@yahoo.it
Website	http://www.asl3.umbria.it

Funders

Funder type

Government

Umbria Local Health Office No.3 (Azienda Sanitaria Locale N.3, Umbria) (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2014		Yes	No

Editorial Notes

20/04/2017: Plain English summary added.