Comparison of Laparoscopic Surgery Versus Open Surgery in the Treatment of Adhesive Small Bowel Obstruction

Helsinki University Central Hospital (HUCH)

Status: Unknown

Conditions: Adhesive Small Bowel Obstruction

Treatments: Procedure: Laparoscopic adhesiolysis; Procedure: Open adhesiolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT01867528

HUCH-95-150513

Details and patient eligibility

About

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 proportion of adhesive small bowel obstructions may be treated nonoperatively, but up to 50-60% may need surgical intervention. Current golden standard for surgical intervention is open adhesiolysis. Recently, retrospective studies have provided encouraging results of laparoscopic adhesiolysis for small bowel obstructions. However, no prospective randomized trials have been carried out and retrospective series carries a high risk for patient selection and bias. Although in general laparoscopy has been associated with shortened hospital stay, less pain and reduced mortality, laparoscopic adhesiolysis for small bowel obstruction has been reported to cause iatrogenic small bowel lesions up to 7% of patients. Aim of the study is to compare open adhesiolysis to laparoscopic adhesiolysis. The investigators hypothesis is that laparoscopic adhesiolysis is safe, will shorten the hospital stay, and reduce mortality compared to open approach.

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Laparoscopic adhesiolysis

Experimental group

Treatment:

Procedure: Laparoscopic adhesiolysis

Open adhesiolysis

Active Comparator group

Treatment:

Procedure: Open adhesiolysis