Specific Training After Stoma Surgery

Colon Cancer Clinical Trial

— STASS  

Official title:

Specific Training After Stoma Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04701853
• Other study ID #: FoU in VGR: 275326
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Göteborg University
• Contact: Monika Fagevik Olsén, PhD
• Phone: +46313421195
• Email: monika.fagevik-olsen[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In Sweden, approximately 43,000 people have undergone surgery with ileo-, colo- or urostomy. The most common type of stomy is a sigmoidostomy. A large proportion, about 50%, of patients who receive a permanent sigmoidostomy develop a parastomal hernia which may have major impact.

There are indications that specific abdominal exercise may reduce the risk of parastomal hernias, but randomized studies are lacking.

The aims of the study are:

1. to evaluate the effect of specific exercise to counteract the development of parastomal hernia in sigmoidostomy and the hernia's impact on ostomy function, physical function and quality of life.

2. to examine patients' experience of living with parastomal hernia. The study plans to include 240 patients who on will undergo surgery and receive a sigmoidostomy. These will be randomized to receive only advice according to the usual routine to avoid the development of parastomal hernia or these advice with the addition of specific abdominal muscle training. The training is initiated before the operation and is then carried out during the first postoperative year. Follow-up will be done with a clinical assessment and with measurement of bulge and size of the parastomal hernia manually, with electronic measuring equipment and via computed tomography images. Patients will assess their stoma and stoma function and assess any discomfort and its consequences of hernia via a study-specific questionnaire. Type of ostomy bandage will also be registered. The evaluation will be carried out 6, 12 and 36 months postoperatively.

Prior to the start of sub-study a, the planned measurement methods to assess whether a parastomal hernia is present will be tested for validity. In addition, a group of patients (≥15 people) with parastomal hernia will be included in a qualitative sub-study where they will be interviewed about their experiences of the hernia hernia and how it may affect daily life.

The present study will be able to answer whether specific exercise can reduce the risk of parastomal hernia. Methods for clinically assessing and evaluating bulging and hernias will be tested and evaluated in relation to patient-reported symptoms. In addition, the study will provide information about the patient's experience of having a parastomal hernia and how it affects daily life and physical activity. The results will provide an increased understanding of parastomal hernias, which may change the follow-up of patients in the future.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• A consecutive series of patients who are scheduled to have a permanent sigmoidostomy

Exclusion Criteria:

• Not Swedish speaking

• Impaired cognitive ability

• Physical disability that limits the possibility of carrying out the intervention.

• Lung disease including chronic cough.

• Previous hernia in the abdominal wall.

• Previous open abdominal surgery with scars =20 cm

• Spread malignant disease at inclusion

• Acute surgery

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Other:
• Specific abdominal muscle training
Specific abdominal muscle training
• Usual care
Care according to each center.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Helsingborgs lasarett	Helsingborg
Sweden	Örebro Universitetssjukhus	Örebro
Sweden	Skövde Sjukhus	Skövde

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parastomal hernia verified by computer tomography	Number of verified parastomal hernia by computer tomography	6 to 36 months after surgery
Secondary	Manual evaluation of parastomal hernia	Visual evaluation of parastomal hernia assessed by Yes/No/Unsure	6 to 36 months after surgery
Secondary	Measurement of parastomal hernia	Size of the hernia by caliper and app	6 to 36 months after surgery
Secondary	Stomal function- symptoms	Questionnaire including stomal function, by Smietanski. 15 items answered by Likert scales from 0 (no symptoms) to 10 (worst imaginable symptoms)	6 to 36 months after surgery
Secondary	Stomal function in daily life	Questionnaire including stomal function in normal life, by Hjortswang 2006. Four questions which are answered by 6-levels Lickert scales from no (0) tom maximal (5) symptoms.	6 to 36 months after surgery
Secondary	Generic Quality of life	EQ-5D Swedish version. 5 questions where lower scores indicate higher quality of life.	6 to 36 months after surgery
Secondary	Stoma specific Quality of Life	Stoma-QoL by Kald et al 2009. 20 questions with answers from 1 (always) to not at all (4).	6 to 36 months after surgery
Secondary	Physical activity level	Grimby Scale, A scale from 1-6 where a higher score indicates higher level of physical activity	Preoperatively to 36 months after surgery
Secondary	Back pain	Back pain questionnaire by Granström et al 2020. Includes two visual analogue scales from 0 (no pain ) to 100 (Worst imaginable pain) mm and six questions which are answered on a Likert scale (4-5 levels) from no to maximal symptoms.	Preoperatively to 36 months after surgery