Condition category
Cancer
Date applied
19/02/2012
Date assigned
02/05/2012
Last edited
20/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.asl3.umbria.it

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24491287

Publication citations

  1. 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.

Additional files

Editorial Notes

20/04/2017: Plain English summary added.