Comparison of Laparoscopic Surgery Versus Open Surgery in the Treatment of Adhesive Small Bowel O… (NCT01867528) | Clinical Trial Compass
UnknownNot Applicable
Comparison of Laparoscopic Surgery Versus Open Surgery in the Treatment of Adhesive Small Bowel Obstruction
Finland, Italy102 participantsStarted 2013-07
Plain-language 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.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-operative hospital stay (days)
Timeframe: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days