Condition category
Cancer
Date applied
19/02/2012
Date assigned
02/05/2012
Last edited
05/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

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 07 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

Ethical Commitee of Regional Public Health System of Umbria, Italy on 15th September 2011, Protocol Number 28657/11/AV

Study design

Multicentre open randomized parallel groups study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

Other

Phase

Not Applicable

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

S.C. Chirurgia Generale
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 07 423 391
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) (Itlay)

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