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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01631-44 | Other Identifier | IDRCB |
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There are many indications for performing a fecal diversion stoma. In both scheduled and emergency situations, and whatever the context (indication or type of fecal diversion stoma), stomal complications can occur early (10-60%) or late (25%), and may require repeat surgery. The most frequent complications are necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions, prolapse or eventration. What's more, a temporary stoma can become permanent.
The positioning and fabrication of the digestive stoma for fecal diversion must therefore comply with well-defined criteria to reduce the risk of stomal complications and the difficulties of fitting the stoma, and thus improve the autonomy and therefore the quality of life of the ostomate patient. The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively. What's more, the psychological impact of a stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and/or surgeons.
The impact of preoperative stoma identification and education on stoma complications, quality of life and patient autonomy has been reported in a few comparative series. The impact of preoperative education on quality of life has also been reported.
However, despite this "Evidence Based Medicine", and the guide to good stoma therapy practice, the identification and education of the future fecal diversion stoma are not always carried out preoperatively. Reasons for this may include lack of time, lack of human resources, in the general context of a shrinking public hospital, or in the current context of distancing and dehumanization of the profession, or lack of conviction on the part of practitioners.
To this end, the investigators would like to propose a prospective observational study aimed at evaluating the impact of identification and education prior to the performance of a fecal diversion stoma in a programmed situation on the one hand, and an emergency situation on the other.
The main objective will be to compare quality of life specifically related to the stoma at 30 days postoperatively with the StomaQOL score, between 2 groups of patients:
Total 100 patients :
Timeline:
Inclusion period: 12 months Follow-up period: 12 months Total duration: 24 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative identification and education | Experimental |
| |
| lack of preoperative identification and education | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preoperative stoma identification and education | Other | The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively, in the lying, sitting and standing positions, so that the patient can see the stoma. What's more, the psychological impact of the stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and/or surgeons. |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnary : quality of life | From enrollment to the end of the study at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence of short-term stomatal complications (within 30 days days post-operatively) | edema, necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions | From intervention to 30 days after intervention |
| Questionnaire about the patient's autonomy when returning home (stoma therapist needed or not; if present, for how long) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MaƩva Donadieu-Masse | Contact | 0491435817 | 33 | promotion.interne@ap-hm.fr |
| Diane MEGE, dr | Contact | 0491435817 | 33 | promotion.interne@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance publique - HƓpitaux de Marseille | Marseille | France |
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|
stoma therapist needed or not; if present, for how long |
| From intervention to 30 days after intervention |
| rate of long-term stomatal complications at 1 year | prolapse, occlusion, ventration | From intervention to1 year after intervention |
| questionnaire on ostomy-specific quality of life, assessed by the StomaQOL score at 30 days, for comparison between identification and education by the stoma nurse or surgeon | From intervention to 30 days after intervention |
| Questionnaire on ostomy-specific quality of life, assessed by the StomaQOL score at 1 years | From intervention to 1 year after intervention |
| SF36 quality of life questionnaire at 30 days and 1 year | From intervention to 1 year after intervention |
| Rate of restoration of digestive continuity at 1 year | From intervention to 1 year after intervention |
| Reasons for not carrying out preoperative identification and education | emergency, surgery at night or on weekends or public holidays, insufficient preoperative time, stoma nurse absent, surgeon's choice, patient's wishes. | From enrollment to the end of the study at 24 months |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D011125 | Adenomatous Polyposis Coli |
| D003424 | Crohn Disease |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D018256 | Adenomatous Polyps |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009386 | Neoplastic Syndromes, Hereditary |
| D044483 | Intestinal Polyposis |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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