Comparison of Laparoscopic Surgery Versus Open Surgery in the Treatment of Adhesive Small Bowel Obstruction
- Conditions
- Adhesive Small Bowel Obstruction
- Interventions
- Procedure: Open adhesiolysisProcedure: Laparoscopic adhesiolysis
- Registration Number
- NCT01867528
- Lead Sponsor
- Helsinki University Central Hospital
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 102
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Open adhesiolysis Open adhesiolysis - Laparoscopic adhesiolysis Laparoscopic adhesiolysis -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Length of epidural catheter analgesia (days) Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days Number of patient with recurrent adhesive small bowel obstruction 10 years Mortality 30 days after randomization Complications, Clavien-Dindo classification 30 days after randomization Number of participants with readmission(s) 30 days after randomization Passage of stools (post-operative days) Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days 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 Length of sick leave (days) Participants will be followed for the duration of sick leave, depending on occupation estimated 1-4 weeks 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 Total need of opioids in milligrams Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days Number of participants that develop ventral hernia 10 years
Trial Locations
- Locations (8)
Tampere University Hospital
🇫🇮Tampere, Finland
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Oulu University Hospital
🇫🇮Oulu, Finland
Päijät-Häme Central Hospital
🇫🇮Lahti, Finland
Vaasa Central Hospital
🇫🇮Vaasa, Finland
Peijas Hospital
🇫🇮Vantaa, Finland
Bologna Maggiore Hospital
🇮🇹Bologna, Italy
Parma University Hospital
🇮🇹Parma, Italy