Effect of Stoma Prehabilitation on Stoma Patients

NCT04692610 | Completed DMC

• 1 other identifier: U1111-1263-2558
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stoma; Anxiety; Depression; Quality of Life

Keywords

Stoma; Self-care; prehabilitation; anxiety; depression; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anxiety and depression score

  postoperative 5th day

• Stoma specific Quality of life

  postoperative 4th week

Study Arms (3)

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.

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.

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.

Behavioral: Stoma prehabilitation; Behavioral: preoperative stoma education; Behavioral: postoperative stoma education; Behavioral: Postoperative stoma care

Interventions

Stoma prehabilitation BEHAVIORAL

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

Group C

preoperative stoma education BEHAVIORAL

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.

Group B; Group C

postoperative stoma education BEHAVIORAL

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.

Group A; Group B; Group C

Postoperative stoma care BEHAVIORAL

Usual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cihangir Akyol: lead

Related Publications (1)

• 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.

  PMID: 35195553 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Mehmet A Koç, MD

  Ankara University School of Medicine Departmernt of General Surgery

  PRINCIPAL INVESTIGATOR

• Cihangir Akyol, MD

  Ankara University School of Medicine Departmernt of General Surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Proffessor

Model Details: 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.

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: November 15, 2011
• Primary Completion: September 15, 2016
• Study Completion: December 15, 2016
• Last Updated: January 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share