Specific Training After Stoma Surgery

Not Applicable

Recruiting

• Conditions: Colon Cancer
• Interventions: Other: Specific abdominal muscle training; Other: Usual care

• Registration Number: NCT04701853
• Lead Sponsor: Göteborg University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Study Start: 2021-05-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Specific abdominal muscle training	Specific abdominal muscle training	Specific abdominal muscle training which is introduced preoperatively and performed the first year after surgery
Usual care treatment	Usual care	No specific abdominal muscle training

Primary Outcome Measures

Name	Time	Method
Parastomal hernia verified by computer tomography	6 to 36 months after surgery	Number of verified parastomal hernia by computer tomography

Secondary Outcome Measures

Name	Time	Method
Stomal function in daily life	6 to 36 months after surgery	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.
Generic Quality of life	6 to 36 months after surgery	EQ-5D Swedish version. 5 questions where lower scores indicate higher quality of life.
Manual evaluation of parastomal hernia	6 to 36 months after surgery	Visual evaluation of parastomal hernia assessed by Yes/No/Unsure
Measurement of parastomal hernia	6 to 36 months after surgery	Size of the hernia by caliper and app
Stomal function- symptoms	6 to 36 months after surgery	Questionnaire including stomal function, by Smietanski. 15 items answered by Likert scales from 0 (no symptoms) to 10 (worst imaginable symptoms)
Physical activity level	Preoperatively to 36 months after surgery	Grimby Scale, A scale from 1-6 where a higher score indicates higher level of physical activity
Back pain	Preoperatively to 36 months after surgery	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.
Stoma specific Quality of Life	6 to 36 months after surgery	Stoma-QoL by Kald et al 2009. 20 questions with answers from 1 (always) to not at all (4).

Trial Locations

Locations (4)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Helsingborgs lasarett; 🇸🇪 Helsingborg, Sweden

Skövde Sjukhus; 🇸🇪 Skövde, Sweden

Örebro Universitetssjukhus; 🇸🇪 Örebro, Sweden