Study to Assess the Impact of an Educational Program for Ostomy Patients (Ostomeducat)
Phase: NA
Conditions: Educational Problems, Colostomy Complications, Surgery, Colorectal Disorders
Sponsor: Mª Victoria Maestre Sanchez

1Study Protocol
“IMPACT OF A PREOPERATIVE OUTPATIENT EDUCATION PROGRAM FOR OSTOMY PATIENTS: A
COHORT-COMPARATIVE PILOT STUDY”
Introduction
Data reported from Spanish Ostomy Association estimate that 1.5‰ of total population are
living with an ostomy.1   Colorectal cancer is the most common diagnosis associated with stoma
formation (80% of the total cases), followed by inflammatory bowel disease in about eight per
cent.2 Currently there´s no doubt about the role of specialized nurse in health education
relative to stoma care and adaptation process.  Preoperative stoma site marking is widely
recommended by the main Scientific Societies related to colorectal and urological cancer. It is
one of the most impactful measures provided by stoma care specialist nurses, as patients have
less  stoma-related  complications  and  higher  postoperative  health-related  quality  of  life
scores.3-5 
Stoma creation after colorectal surgery is recognized in some studies as an independent cause
of  prolonged  hospital  stay  and  readmissions.6-7   
 However,  other  publications  have  not
confirmed this point. Gumbao et al, in a retrospective study, reported no differences in
postoperative complications or postoperative stay including readmissions between patients
who  underwent  anterior  rectal  resection  and  anastomosis  with  or  without  a  diverting
ileostomy, in the setting of a multidisciplinary team and a multimodal rehabilitation program. 8
Studies  suggest  that  preoperative  education  and  counseling  has  proven  to  result  in
significantly better competence in self-care stoma and enhancement in self-management of
complications.9-10  Nevertheless, there is a lack of data regarding the optimal timing of planned
teaching.  Studies developed in other fields like breast cancer surgery, indicate that women
1
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postoperatively experience a decreased ability to direct attention and perform tasks.11  This is
consistent with the study published by Cupples concerning recovery from cardiac surgery,
concluding that patients who received education 5 to 14 days preoperatively, a preoperative
phone call, as well as postoperative teaching, had higher preoperative knowledge and lower
postoperative anxiety states than patients who only received preoperative teaching after
admission to the hospital.12 Additionally, the incorporation of minimally invasive surgery results
in shorter hospitalizations and less time gaining proficiency in stoma management.
 Up to date, conventional practice in our team involved stoma education being imparted
postoperatively. Given that, we questioned if implementing a preoperative program could
influence postoperative course in new ostomate patients. The purpose of this study is to
evaluate the effectiveness of preoperatively education in the outpatient setting in reducing
length of stay for stoma patients, compared to standard postoperative care.  Secondary end
points will be minor and mayor morbidity, mortality, reoperation and readmission rates
assessment. 
Material and Methods
Consecutive colorectal surgery patients undergoing stoma formation in a single center will be
recorded in a cohort study, during a 12-month period. Records will be retrospectively collected
before outpatient information program establishment and prospectively in the second study
period.   Data and personal identities of individual participants are coded to ensure patient
confidentiality. Patients in the standard group received stoma education after surgery, during
hospital  stay,  and  patients  in  the  intervention  group  received  the  same  information
preoperatively in outpatient setting.  
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Inclusion criteria considered for scheduled preoperative clinic visit: patients  older than 18
years of age undergoing elective colorectal resections that eventually would require formation
of  a  stoma  (colorectal  cancer  up  to  20  cm  from  the  anal  verge, colonic  poliposis  and
inflammatory bowel disease). Patients will be excluded from the study if they already had a
stoma before the operation or in case of emergent surgery. 
Patients in the study group have one individual consultation 45 minutes in duration several
days before surgery with the stoma nurse specialist, following standard ostomy teaching plans
(displayed in Table 1).
1.
General information about what is a stoma and different types of stoma
2.
Potential surgical procedure
3.
Information about stoma marking (benefits and timing to perform)
4.
How to care your ostomy
5.
Effect of the diet on ostomy management
6.
An overview on dietary advice
7.
Types of ostomy bags
8.
Complications that may arise after an incorrect apply of a new pouching system 
9.
How to manage peristomal skin irritation if necessary
10. Influence of stoma on quality of life
11. Sports and fitness activities you are able to do with a stoma
12. How and where get the pouches 
13. Who to ask if you are in doubt  about any procedure
14. Information for family and caregivers
Table 1. Information for ostomy patients
In both groups and in all cases, the stoma site will be marked the same day of surgery.
Patients,  except  for  specific  contraindication,  follow  the  Enhanced  Recovery  Pathways
established in our colorectal Unit and approved by Local Quality Committee. All procedures
will be performed or supervised by a specialist colorectal surgeon. Patients, irrespective of the
group, are visited in the ward by the  enterostoma therapist one or two days after stoma
creation, emphasizing basic skills to optimize the ability to perform independently stoma care.
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The discharge and readmission criteria are similar for both treatment groups and followed
conventional protocols and care pathways set in our working group. 
Data  collected included age, gender, American  Society of  Anesthesiologists (ASA)  grade,
diagnosis, surgical approach and type of stoma. Measurement variables are complications and
mortality rates (assessed by Clavien-Dindo Classification), reinterventions, readmissions within
the first 30 days after surgery and length of hospital stay. Similar data will be retrospectively
collected for patients prior to the introduction of the preoperative education program.
All statistical analyses are performed using SPSS version 20 (SPSS Inc., Chicago, IL, EE. UU.).
Continuously  variables  were  tested  by  Students  T-test,  Mann-Whitney  U  for  numerical
variables and Pearson's Two-sided Chi-square Test for dichotomous variables or Fisher test for
qualitative variables. An alpha level of .05 was used to determine statistical significance.
The article will be reported in line with the STROCSS criteria.13
References
1. García Hernando M. Plan de cuidados de un paciente ostomizado. Reduca 2013; 5:1-4.
2.  Martin  ST,  Vogel  JD.  Intestinal  Stomas:  Indications,  Management,  and  Complications.
Advances in Surgery 2012; 46:19-49. 
3. Salvadalena G, Hendren S, McKenna L, et al. WOCN Society and ASCRS position statement
on preoperative stoma site marking for patients undergoing colostomy or ileostomy surgery. J
Wound Ostomy Continence Nurs 2015; 42:249–52.
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4. Millan M , Tegido M , Biondo S , Garcia-Granero E . Pre-operative stoma siting and education
by stoma therapists of colorectal patients: a descriptive study in twelve colorectal surgical unit.
Colorectal Dis 2010; 12:88-92.
5. Mckenna LS, Taggart E, Stoelting J, Kirkbride G, Forbes GB. The impact of preoperative
stoma marking on healthrelated quality of life: a comparison cohort study. J Wound Ostomy
Continence Nurs 2016; 43:57–61.
6. Cartmell MT, Moran BJ, Cecil TD. A defunctioning stoma significantly prolongs the length of
stay in laparoscopic colorectal resection. Surg Endosc 2008: 22:2643–47.
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Randomized controlled trial comparing laparoscopic and open surgery for colorectal cancer
within an enhanced recovery programme. BJS 2006; 93:300–8
8. Gumbao V, García-Armengol G, Salvador-Martínez A, Ivorra P, García-Coret MJ, García-
Rodríguez V, et al. Impact of a diverting stoma in an enhanced recovery programme for rectal
cancer. Cir Esp. 2015; 93:18-22.
9. Chaudhri S, Brown I, Hasson I, Horgan AF. Preoperative intensive community-based vs
traditional stoma education: A randomized, controlled trial. Dis Colon Rectum. 2005; 48:504–9.
10. Danielsen AK, Burcharth J, Rosenberg J. Patient education has a positive effect in patients
with a stoma – a systematic review. Colorectal Dis. 2013; 15: 276–83.
11. Cimprich, B. Attentional fatigue following breast cancer surgery.  Res Nurs Health 1992;
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12. Cupples SA. Effects of timing and reinforcement of preoperative education on knowledge
and recovery of patients having coronary artery bypass graft surgery.  Heart and Lung 1991;
20:654-60.
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13. Agha RA, Borrelli MR, Vella-Baldacchino M, Thavayogan R and Orgill DP, for the STROCSS 
Group.  The STROCSS Statement: Strengthening the Reporting of Cohort Studies in Surgery. 
International Journal of Surgery 2017;46:198-202.
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