Status:
UNKNOWN
Comparison of Laparoscopic Surgery Versus Open Surgery in the Treatment of Adhesive Small Bowel Obstruction
Lead Sponsor:
Helsinki University Central Hospital
Conditions:
Adhesive Small Bowel Obstruction
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief Summary
Small bowel obstruction is a common reason for surgical admission. Most common reason for small bowel obstruction is adhesions, which account up to 70-80 % of small bowel obstructions. Large proportio...
Eligibility Criteria
Inclusion
- All patients with clinical and computed tomography-diagnosed adhesive small bowel obstruction AND
- Obstruction is not relieved by conservative methods (nasogastric tube, NPO) including Gastrografin is not passed to colon within 8 hours (48-hour conservative treatment without Gastrografin® is allowed if Gastrografin® is contraindicated (e.g. allergy) or not available)
Exclusion
- Strong suspicion of strangulation or clinical peritonitis thus indicating an urgent operative intervention
- Earlier confirmed or strongly suspected peritoneal carcinosis
- Earlier confirmed wide diffuse adhesions of abdominal cavity
- Earlier open surgery for endometriosis
- Earlier generalized diffuse peritonitis (not including local peritonitis such as appendicitis)
- Active abdominal malignancy or remission less than 10 years
- Earlier abdominal region radiotherapy
- Earlier obesity surgery
- 3 or more earlier open abdominal operations (not including caesarean section(s))
- Suspicion of other cause for obstruction than adhesions in CT-scan
- Earlier abdominal surgical operation within 30 days
- Earlier surgical operation for aorta or iliac vessels performed through laparotomy
- Crohn's disease
- Anesthesiological contraindication for laparoscopy
- Missing informed consent
- Age less than 18 years or over 95 years
- Pregnancy
- Patient living in institutional care (such as health centre ward), not including retirement homes
- Over 1 week of hospital stay directly prior surgical consultation
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01867528
Start Date
July 1 2013
Last Update
June 19 2018
Active Locations (8)
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1
Helsinki University Central Hospital
Helsinki, Finland
2
Päijät-Häme Central Hospital
Lahti, Finland
3
Oulu University Hospital
Oulu, Finland
4
Tampere University Hospital
Tampere, Finland