Specific Training After Stoma Surgery

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Parastomal hernia verified by computer tomography [Срок оценки: 6 to 36 months after surgery]

Вторичные конечные точки (8)

• Manual evaluation of parastomal hernia [Срок оценки: 6 to 36 months after surgery]
• Measurement of parastomal hernia [Срок оценки: 6 to 36 months after surgery]
• Stomal function- symptoms [Срок оценки: 6 to 36 months after surgery]
• Stomal function in daily life [Срок оценки: 6 to 36 months after surgery]
• Generic Quality of life [Срок оценки: 6 to 36 months after surgery]
• Stoma specific Quality of Life [Срок оценки: 6 to 36 months after surgery]
• Physical activity level [Срок оценки: Preoperatively to 36 months after surgery]
• Back pain [Срок оценки: Preoperatively to 36 months after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Швеция · 4 центра

• Sahlgrenska University Hospital — Gothenburg
• Helsingborgs lasarett — Helsingborg
• Örebro Universitetssjukhus — Örebro
• Skövde Sjukhus — Skövde

Идентификаторы

NCT: NCT04701853 · FoU in VGR: 275326

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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