Small Bowel Obstruction, Small Bowel Adhesion
Conditions
Keywords
Acute adhesive intestinal obstruction, conservative treatment
Brief summary
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).
Detailed description
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.
Interventions
PROCEDUREAdhesiolysis
Median laparotomy with subsequent detection of intestinal obstruction cause and adhesiolysis.
RADIATIONX-ray examination
Plain X-ray of abdomen (1-4 times) with water insoluble contrast.
PROCEDUREConservative treatment
A set of measures aimed at non-operative resolution of acute intestinal obstruction - nasogastric tube, infusion therapy.
Sponsors
North-Western State Medical University named after I.I.Mechnikov
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking is expected due to the nature of interventions
Intervention model description
Multicenter controlled randomized prospective study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with acute intestinal obstruction
Exclusion criteria
* pregnancy; * peritonitis or strangulation, revealed during primary examination; * early acute small bowel obstruction (presence of anamnestic surgical intervention within 6 month)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-operative treatment success | 72 hours | Frequency of non-operative intestinal obstruction resolution |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall mortality | up to 30 days | Number of patients, died during hospitalization |
| Postoperative complications | up to 30 days | Number and variety of postoperative complications in patients, who underwent surgery |
| Resectional interventions | up to 30 days | Number of patients, who underwent surgery, including small bowel resection |
Countries
Russia
Contacts
Primary ContactPavel A Kotkov, PhD
Backup ContactBadri V Sigua, MD
Outcome results
None listed