Specific Training After Stoma Surgery

NCT04701853 | Recruiting

• 1 other identifier: FoU in VGR: 275326
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

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. 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. 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.

Conditions

Colon Cancer

Keywords

Hernia; Abdominal muscles; Stabilizing training

Outcome Measures

Primary Outcomes (1)

• Parastomal hernia verified by computer tomography

  Number of verified parastomal hernia by computer tomography

  6 to 36 months after surgery

Secondary Outcomes (8)

• Manual evaluation of parastomal hernia

  6 to 36 months after surgery

• Measurement of parastomal hernia

  6 to 36 months after surgery

• Stomal function- symptoms

  6 to 36 months after surgery

• Stomal function in daily life

  6 to 36 months after surgery

• Generic Quality of life

  6 to 36 months after surgery

Study Arms (2)

Specific abdominal muscle training

EXPERIMENTAL

Specific abdominal muscle training which is introduced preoperatively and performed the first year after surgery

Other: Specific abdominal muscle training

Usual care treatment

ACTIVE COMPARATOR

No specific abdominal muscle training

Other: Usual care

Interventions

Specific abdominal muscle training OTHER

Specific abdominal muscle training

Specific abdominal muscle training

Usual care OTHER

Care according to each center.

Usual care treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Acute surgery

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (4)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

RECRUITING

Helsingborgs lasarett

Helsingborg, Sweden

RECRUITING

Örebro Universitetssjukhus

Örebro, Sweden

RECRUITING

Skövde Sjukhus

Skövde, Sweden

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Hernia

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Monika Fagevik Olsén, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monika Fagevik Olsén, PhD

CONTACT

+46313421195; monika.fagevik-olsen@vgregion.se

Monika Fagev ik Olsén, PhD

CONTACT

+4631 342 1195; monika.fagevik-olsen@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor will not be aware of which group the patients are included in.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single blind, randomized, controlled, intervention study. Evaluation of the addition of specific muscle training for patients undergoing intestine surgery including a sigmoidostomy compared to standard care

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 8, 2021
• Study Start: May 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

SE (4)