search
Back to results

Effect of Stoma Prehabilitation on Stoma Patients

Primary Purpose

Stoma, Anxiety, Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stoma prehabilitation
preoperative stoma education
postoperative stoma education
Postoperative stoma care
Sponsored by
Cihangir Akyol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stoma focused on measuring Stoma, Self-care, prehabilitation, anxiety, depression, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Experimental

    Arm Label

    Group A

    Group B

    Group C

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    December 30, 2020
    Last Updated
    January 1, 2021
    Sponsor
    Cihangir Akyol
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04692610
    Brief Title
    Effect of Stoma Prehabilitation on Stoma Patients
    Official Title
    Effect of Prehabilitation on Stoma Self-Care, Anxiety, Depression and Quality of Life in Stoma Patients: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    November 15, 2011 (Actual)
    Primary Completion Date
    September 15, 2016 (Actual)
    Study Completion Date
    December 15, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Cihangir Akyol

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stoma, Anxiety, Depression, Quality of Life
    Keywords
    Stoma, Self-care, prehabilitation, anxiety, depression, quality of life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    240 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Stoma prehabilitation
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    preoperative stoma education
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    postoperative stoma education
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Postoperative stoma care
    Intervention Description
    Usual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion
    Primary Outcome Measure Information:
    Title
    Stoma self-care ability
    Description
    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.
    Time Frame
    stoma follow-up was continued up to the 12th week
    Secondary Outcome Measure Information:
    Title
    Anxiety and depression score
    Description
    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.
    Time Frame
    postoperative 5th day
    Title
    Stoma specific Quality of life
    Description
    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.
    Time Frame
    postoperative 4th week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mehmet A Koç, MD
    Organizational Affiliation
    Ankara University School of Medicine Departmernt of General Surgery
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Cihangir Akyol, MD
    Organizational Affiliation
    Ankara University School of Medicine Departmernt of General Surgery
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35195553
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Effect of Stoma Prehabilitation on Stoma Patients

    We'll reach out to this number within 24 hrs