Effect of Stoma Prehabilitation on Stoma Patients

Effect of Prehabilitation on Stoma Self-Care, Anxiety, Depression and Quality of Life in Stoma Patients: A Randomized Controlled Trial

Stoma has serious psychosocial effects on patients. Stoma prehabilitation has a potential to overcome these problems. Patients in prehabilitation group were attached with a water-filled stoma pouch (250 ml) 48 hours before surgery. These pouches were not removed until surgery, and enterostomal therapy nurse preoperatively taught the patients how to manage the stoma pouch with similar standards as the usual postoperative stoma-care.

This study aims to measure the effects of prehabilitation on stoma self-care, quality of life, anxiety and depression levels.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Anxiety; Stoma
• Intervention / Treatment: Behavioral: postoperative stoma education; Behavioral: Postoperative stoma care; Behavioral: preoperative stoma education; Behavioral: Stoma prehabilitation

Detailed Description

Stoma has serious psychosocial effects on patients. Stoma prehabilitation has a potential to overcome these problems. Patients in prehabilitation group were attached with a water-filled stoma pouch (250 ml) 48 hours before surgery. These pouches were not removed until surgery, and enterostomal therapy nurse preoperatively taught the patients how to manage the stoma pouch with similar standards as the usual postoperative stoma-care.

This study aims to measure the effects of prehabilitation on stoma self-care, quality of life, anxiety and depression levels.

A total of 240 patients met the inclusion criteria and were randomly assigned into three groups with the use of a prepared computerized block design by the biostatistician. Twenty-two patients were excluded and 218 patients were included in the analysis.

Each group had a different protocol:

Group A - Postoperative Group received stoma education and stoma care after surgery beginning from the postoperative day-1; Group B - Pre- and Postoperative Group received stoma education both before surgery and on the postoperative day-1. They received stoma care postoperatively as usual; Group C - Prehabilitation Group received the same protocol as Group B, however in addition they were prehabilitated with a water-filled stoma pouch (250 ml) 48 hours before surgery. These pouches were not removed until surgery, and enterostomal therapy (EST) nurse preoperatively taught the patients how to manage the stoma pouch with similar standards as the usual postoperative stoma-care.

Stoma site marking: Preoperative stoma site marking improves patients' QoL and independence in the postoperative period and decreases postoperative complications. In elective cases this should be considered as a must. In the current study all the patients' stoma sites were marked preoperatively by an EST nurse according to some important rules. Patients' abdominal surfaces were observed carefully for folds, scars, and creases in lying and standing positions. Bilateral points were chosen by paying attention to the planned incision line and the borders of the rectus muscle. At the end we had all the patients confirm they can see the marked sites.

Stoma education: A consultation period for stoma education by an EST nurse was approximately 45 minutes. Patients were shown pictures of a stoma. The stoma-care equipments and a pouch were also shown to the patients and they were informed about these equipments. They were also provided information about daily living with a stoma.

Stoma prehabilitation: A stoma pouch was attached to the marked stoma site on the patient's abdominal surface after stoma education (only in group C). EST nurse filled 250 ml water into the pouch. Patients lived with these pouches until surgery. They experienced walking, sitting, sleeping, changing clothes with a pouch. They learned how to empty it. When a leak occurred, the pouch was changed by the nurse.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who underwent elective colorectal surgery and faecal diversion in the Ankara University Department of General Surgery between 2011 and 2016
• Patients with malignancy,
• Patients with polyposis syndrome,
• Patients with inflammatory bowel disease,
• Patients with diverticular disease
• Patients with perianal benign diseases

Exclusion Criteria:

• those who underwent emergency surgery
• those who developed stoma complications
• disoriented patients who could not cooperate
• patients with psychiatric disease
• patients with noncurable malign disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A; Postoperative Education Group received stoma education and stoma care after surgery beginning from the postoperative day-1. In the preoperative period they were informed about stoma and stoma sites were marked.	Behavioral: postoperative stoma education; A consultation period for stoma education by an EST nurse was approximately 45 minutes. Patients were shown pictures of a stoma. The stoma-care equipments and a pouch were also shown to the patients and they were informed about these equipments. They were also provided information about daily living with a stoma.; Behavioral: Postoperative stoma care; Usual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion
Active Comparator: Group B; Pre- and Postoperative Education Group received stoma education both before surgery and on the postoperative day-1. They received stoma care postoperatively as usual. In the preoperative period they were also informed about stoma and stoma sites were marked.	Behavioral: postoperative stoma education; A consultation period for stoma education by an EST nurse was approximately 45 minutes. Patients were shown pictures of a stoma. The stoma-care equipments and a pouch were also shown to the patients and they were informed about these equipments. They were also provided information about daily living with a stoma.; Behavioral: Postoperative stoma care; Usual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion; Behavioral: preoperative stoma education; A consultation period for stoma education by an EST nurse was approximately 45 minutes. Patients were shown pictures of a stoma. The stoma-care equipments and a pouch were also shown to the patients and they were informed about these equipments. They were also provided information about daily living with a stoma.
Experimental: Group C; Prehabilitation Group received the same protocol as Group B, however in addition they were prehabilitated with a water-filled stoma pouch (250 ml) 48 hours before surgery. These pouches were not removed until surgery, and EST nurse preoperatively taught the patients how to manage the stoma pouch with similar standards as the usual postoperative stoma-care.	Behavioral: postoperative stoma education; A consultation period for stoma education by an EST nurse was approximately 45 minutes. Patients were shown pictures of a stoma. The stoma-care equipments and a pouch were also shown to the patients and they were informed about these equipments. They were also provided information about daily living with a stoma.; Behavioral: Postoperative stoma care; Usual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion; Behavioral: preoperative stoma education; A consultation period for stoma education by an EST nurse was approximately 45 minutes. Patients were shown pictures of a stoma. The stoma-care equipments and a pouch were also shown to the patients and they were informed about these equipments. They were also provided information about daily living with a stoma.; Behavioral: Stoma prehabilitation; A stoma pouch was attached to the marked stoma site on the patient's abdominal surface after stoma education (only in group C). EST nurse filled 250 ml water into the pouch. Patients lived with these pouches until surgery. They experienced walking, sitting, sleeping, changing clothes with a pouch. They learned how to empty it. When a leak occurred, the pouch was changed by the nurse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stoma self-care ability	All the patients with stoma were followed up by an enterostomal therapy nurse according to each group's own protocol. A stoma care follow-up form was completed beginning from the stoma education given by the nurse on the postoperative day-1 for all groups. Although patients in group C had learned how to manage a stoma pouch before surgery, their stoma-care follow-up forms were also completed after surgery beginning with the postoperative day-1. When the patient managed to empty the pouch with and without help, and when the patient was able to perform stoma care with the passive and active help of the nurse were recorded. And finally the day when the patient managed to perform stoma self-care was also recorded.	stoma follow-up was continued up to the 12th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and depression score	Hospital anxiety and depression scale (HADS) has long been used to measure anxiety and depression, and has been validated for several times including Turkish population. According to the ROC analysis, the cut-off points of the Turkish form of the HAD scale were determined as 10 for the anxiety subscale and 7 for the depression subscale.	postoperative 5th day
Stoma specific Quality of life	Quality of life was measured with the Stoma-QoL questionnaire which is an internationally recognized global feature. It has been validated in Turkish patients. The Stoma-QoL questionnaire covered 4 domains: sleep, sexual activity, relations to family and close friends, and social relations outside family and close friends. Each item uses a Likert scale from 1 to 4 and the total score ranges from 20 to 80.	postoperative 4th week

Collaborators and Investigators

• Sponsor: Cihangir Akyol
• Investigators: Study Chair: Cihangir Akyol, MD, Ankara University School of Medicine Departmernt of General Surgery; Principal Investigator: Mehmet A Koç, MD, Ankara University School of Medicine Departmernt of General Surgery

Publications and helpful links

General Publications

• Koc MA, Akyol C, Gokmen D, Aydin D, Erkek BA, Kuzu MA. Effect of Prehabilitation on Stoma Self-Care, Anxiety, Depression and Quality of Life in Stoma Patients: A Randomized Controlled Trial. Dis Colon Rectum. 2022 Feb 21. doi: 10.1097/DCR.0000000000002275. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2011
• Primary Completion (Actual): September 15, 2016
• Study Completion (Actual): December 15, 2016

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 1, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; depression; anxiety; prehabilitation; Self-care; Stoma
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: U1111-1263-2558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No