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

Study Overview
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Brief Summary
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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.

Official Title
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Laparoscopic Versus Open Adhesiolysis for Small Bowel Obstruction - A Multicenter, Prospective, Randomized, Controlled Trial

Conditions
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Adhesive Small Bowel Obstruction

Intervention / Treatment
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* Procedure: Laparoscopic adhesiolysis
* Procedure: Open adhesiolysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic adhesiolysis<br> | Procedure: Laparoscopic adhesiolysis<br> <br> |
| Active Comparator: Open adhesiolysis<br> | Procedure: Open adhesiolysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative hospital stay (days) |  | Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Passage of stools (post-operative days) |  | Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days | 
| Commence of enteral nutrition (post-operative days) |  | Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days | 
| Mortality |  | 30 days after randomization | 
| Complications, Clavien-Dindo classification |  | 30 days after randomization | 
| Number of participants with iatrogenic small bowel lesions |  | Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days | 
| Number of participants with readmission(s) |  | 30 days after randomization | 
| Number of participant with failure to relieve obstruction |  | Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days | 
| Pain scores on the Visual Analog Scale |  | Postoperative days 1- 7 or till discharge | 
| Length of epidural catheter analgesia (days) |  | Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days | 
| Total need of opioids in milligrams |  | Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days | 
| Length of sick leave (days) |  | Participants will be followed for the duration of sick leave, depending on occupation estimated 1-4 weeks | 
| Number of participants that develop ventral hernia |  | 10 years | 
| Number of patient with recurrent adhesive small bowel obstruction |  | 10 years |