StomaNCT04692610
Effect of Stoma Prehabilitation on Stoma Patients
A study testing Stoma prehabilitation, preoperative stoma education and postoperative stoma education in people with Stoma and Anxiety, run by Cihangir Akyol.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma, Anxiety, Depression
- What is being tested?
- Stoma prehabilitation, preoperative stoma education and postoperative stoma education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2011to 15 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Stoma, Anxiety, Depression, Quality of Life
- Being tested
- Stoma prehabilitation, preoperative stoma education, postoperative stoma education, Postoperative stoma care
- Keywords
- Stoma, Self-care, prehabilitation, anxiety, depression, quality of life
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stoma prehabilitationBehavioural
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 educationBehavioural
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 educationBehavioural
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 careBehavioural
Usual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | 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. Receives: Behavioral: postoperative stoma education; Behavioral: Postoperative stoma care |
| Group B | Active comparator | 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. Receives: Behavioral: preoperative stoma education; Behavioral: postoperative stoma education; Behavioral: Postoperative stoma care |
| Group C | Experimental | 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. Receives: Behavioral: Stoma prehabilitation; Behavioral: preoperative stoma education; Behavioral: postoperative stoma education; Behavioral: Postoperative stoma care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: stoma follow-up was continued up to the 12th week
Secondary outcomes (2)
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.
Measured: 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.
Measured: postoperative 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Nov 2011
- Primary completion15 Sep 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 (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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cihangir Akyol
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cihangir Akyol, Ankara University
- Investigators
- Mehmet A Koç, MD, Principal investigator, Ankara University School of Medicine Departmernt of General SurgeryCihangir Akyol, MD, Study chair, Ankara University School of Medicine Departmernt of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692610
- Sponsor's protocol ID
- U1111-1263-2558
- Status last verified
- Jan 2021
- First submitted
- 30 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35195553
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prehabilitation on Stoma Self-Care, Anxiety, Depression and Quality of Life in Stoma Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04692610
- Acronym / sponsor ID
- U1111-1263-2558
- Conditions
- Stoma, Anxiety, Depression, Quality of Life
- Keywords
- Stoma, Self-care, prehabilitation, anxiety, depression, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Cihangir AkyolUniversity, hospital or other
- Study start
- 15 Nov 2011 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 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 (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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Behavioral: postoperative stoma education, Behavioral: Postoperative stoma carePostoperative 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. |
| Group B | Active comparator | Behavioral: preoperative stoma education, Behavioral: postoperative stoma education, Behavioral: Postoperative stoma carePre- 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. |
| Group C | Experimental | Behavioral: Stoma prehabilitation, Behavioral: preoperative stoma education, Behavioral: postoperative stoma education, Behavioral: Postoperative stoma carePrehabilitation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stoma prehabilitationA 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 | Behavioural | Group C |
| preoperative stoma educationA 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. | Behavioural | Group B, Group C |
| postoperative stoma educationA 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. | Behavioural | Group A, Group B, Group C |
| Postoperative stoma careUsual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion | Behavioural | Group A, Group B, Group C |
Primary outcome
Stoma self-care ability
Time frame: stoma follow-up was continued up to the 12th week
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.
2 secondary outcomes
Anxiety and depression score
Time frame: postoperative 5th day
Stoma specific Quality of life
Time frame: postoperative 4th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 35195553Koc 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet A Koç, MD principal investigator
Ankara University School of Medicine Departmernt of General Surgery
Cihangir Akyol, MD study chair
Ankara University School of Medicine Departmernt of General Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Stoma prehabilitation, preoperative stoma education and postoperative stoma education in people with Stoma and Anxiety, run by Cihangir Akyol.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stoma self-care ability (time frame: stoma follow-up was continued up to the 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04692610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.