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This study will compare the results of 24 h conservative treatment and N h conservative treatment of adhesive small bowel obstruction (where N = 72 h minus duration of intestinal obstruction).
Patients with acute adhesive intestinal obstruction, who dont need an emergency operation, will be given water insoluble contrast per os and randomized into two groups - early and delayed surgery. The first group will receive conservative treatment within no more than 24 h. Duration of non-operative treatment in second group will be 72 h minus duration of intestinal obstruction, based on the onset of symptoms. In both groups surgery will be performed if contrast will not reach colon in mentioned terms or clinical deterioration signs will appear. The results of 24 h conservative treatment and N h conservative treatment (where N = 72 h minus duration of intestinal obstruction) will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short conservative treatment | Active Comparator | Conservative treatment will be performed within no more than 24 h. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear. |
|
| Prolonged conservative treatment | Experimental | Conservative treatment will be performed within N h, where N = 72 h minus duration of acute intestinal obstruction. Surgery will be performed in the absence of contrast in colon according to X-ray examination and if signs of clinical degradation will appear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adhesiolysis | Procedure | Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-operative treatment success | Frequency of non-operative intestinal obstruction resolution | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Overall mortality | Number of patients, died during hospitalization | up to 30 days |
| Postoperative complications | Number and variety of postoperative complications in patients, who underwent surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pavel A Kotkov, PhD | Contact | +79062619231 | kotkovdr@mail.ru | |
| Badri V Sigua, MD | Contact | +79111979343 | dr.sigua@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 26 City Hospital | Recruiting | Saint Petersburg | Russia |
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Multicenter controlled randomized prospective study
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No masking is expected due to the nature of interventions
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| X-ray examination | Radiation | Plain X-ray of abdomen (1-4 times) with water insoluble contrast. |
|
| Conservative treatment | Procedure | A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy. |
|
| up to 30 days |
| Resectional interventions | Number of patients, who underwent surgery, including small bowel resection | up to 30 days |
| North-Western State Medical University named after I. I. Mechnikov | Recruiting | Saint Petersburg | Russia |
|
| Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine | Recruiting | Saint Petersburg | Russia |
|
| The City Hospital of the Holy Martyr Elizabeth | Recruiting | Saint Petersburg | Russia |
|
| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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