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

Helsinki University Central Hospital102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Adhesive Small Bowel Obstruction

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (8)

Helsinki University Central Hospital

Helsinki, Finland

Päijät-Häme Central Hospital

Lahti, Finland

Oulu University Hospital

Oulu, Finland

Tampere University Hospital

Tampere, Finland

Vaasa Central Hospital

Vaasa, Finland

Peijas Hospital

Vantaa, Finland

Bologna Maggiore Hospital

Bologna, Italy

Parma University Hospital

Parma, Italy