Study Results
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Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2011-11-15
2016-12-15
Brief Summary
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This study aims to measure the effects of prehabilitation on stoma self-care, quality of life, anxiety and depression levels.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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 (Figure 2). 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.
The goal of the present study was to evaluate the stoma self-care ability, anxiety, depression and QoL of patients who underwent colorectal surgery and faecal diversion, and focusing on the effect of prehabilitation.
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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.
Postoperative stoma care
Usual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion
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.
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.
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.
Postoperative stoma care
Usual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion
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.
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
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.
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.
Postoperative stoma care
Usual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion
Interventions
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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
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.
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.
Postoperative stoma care
Usual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion
Eligibility Criteria
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Inclusion Criteria
* 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 developed stoma complications
* disoriented patients who could not cooperate
* patients with psychiatric disease
* patients with noncurable malign disease
18 Years
ALL
No
Sponsors
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Cihangir Akyol
OTHER
Responsible Party
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Cihangir Akyol
Associate Proffessor
Principal Investigators
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Mehmet A Koç, MD
Role: PRINCIPAL_INVESTIGATOR
Ankara University School of Medicine Departmernt of General Surgery
Cihangir Akyol, MD
Role: STUDY_CHAIR
Ankara University School of Medicine Departmernt of General Surgery
References
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Koc MA, Akyol C, Gokmen D, Aydin D, Erkek AB, Kuzu MA. Effect of Prehabilitation on Stoma Self-Care, Anxiety, Depression, and Quality of Life in Patients With Stomas: A Randomized Controlled Trial. Dis Colon Rectum. 2023 Jan 1;66(1):138-147. doi: 10.1097/DCR.0000000000002275. Epub 2022 Feb 21.
Other Identifiers
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U1111-1263-2558
Identifier Type: -
Identifier Source: org_study_id
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