Clinical trial NCT04692610: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stoma
Anxiety
Depression
Quality of Life
Keywords: Stoma
Self-care
prehabilitation
anxiety
depression
quality of life
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Stoma self-care ability
timeFrame: stoma follow-up was continued up to the 12th week
Secondary outcomes:
measure: Anxiety and depression score
timeFrame: postoperative 5th day
measure: Stoma specific Quality of life
timeFrame: postoperative 4th week
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University School of Medicine Departmernt of General Surgery
name: Mehmet A Koç, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University School of Medicine Departmernt of General Surgery
name: Cihangir Akyol, MD
role: STUDY_CHAIR
References:
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.