Adhesive Small Bowel ObstructionNCT01867528
Comparison of Laparoscopic Surgery Versus Open Surgery in the Treatment of Adhesive Small Bowel Obstruction
A study testing Laparoscopic adhesiolysis and Open adhesiolysis in people with Adhesive Small Bowel Obstruction, run by Helsinki University Central Hospital at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Adhesive Small Bowel Obstruction
- What is being tested?
- Laparoscopic adhesiolysis and Open adhesiolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jul 2013to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Finland6 sites
Helsinki University Central Hospital
Helsinki
Päijät-Häme Central Hospital
Lahti
Oulu University Hospital
Oulu
Tampere University Hospital
Tampere
Vaasa Central Hospital
Vaasa
Peijas Hospital
Vantaa
About this study
Official title: Laparoscopic Versus Open Adhesiolysis for Small Bowel Obstruction - A Multicenter, Prospective, Randomized, Controlled Trial
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.
- Conditions
- Adhesive Small Bowel Obstruction
- Being tested
- Laparoscopic adhesiolysis, Open adhesiolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic adhesiolysisProcedure or surgery
Open adhesiolysisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic adhesiolysis | Experimental | Not described Receives: Procedure: Laparoscopic adhesiolysis |
| Open adhesiolysis | Active comparator | Not described Receives: Procedure: Open adhesiolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative hospital stay (days)
Measured: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Secondary outcomes (13)
Passage of stools (post-operative days)
Measured: 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)
Measured: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Mortality
Measured: 30 days after randomization
Complications, Clavien-Dindo classification
Measured: 30 days after randomization
Number of participants with iatrogenic small bowel lesions
Measured: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Number of participants with readmission(s)
Measured: 30 days after randomization
Number of participant with failure to relieve obstruction
Measured: 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
Measured: Postoperative days 1- 7 or till discharge
Length of epidural catheter analgesia (days)
Measured: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Total need of opioids in milligrams
Measured: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Length of sick leave (days)
Measured: Participants will be followed for the duration of sick leave, depending on occupation estimated 1-4 weeks
Number of participants that develop ventral hernia
Measured: 10 years
Number of patient with recurrent adhesive small bowel obstruction
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adhesive Small Bowel ObstructionStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ville Sallinen, Helsinki University Central Hospital
- Investigators
- Ville Sallinen, MD, PhD, Principal investigator, Helsinki University Central HospitalPanu Mentula, MD, PhD, Study director, Helsinki University Central HospitalAri Leppäniemi, MD, PhD, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867528
- Sponsor's protocol ID
- HUCH-95-150513
- Status last verified
- Jun 2018
- First submitted
- 26 May 2013
- Last updated
- 19 Jun 2018
- Results posted
- No
Publications
Raty P, Mentula P, Haukijarvi E, Juusela R, Wikstrom H, Koivukangas V, Enholm B, Di Saverio S, Birindelli A, Catena F, Leppaniemi A, Sallinen V. Long-Term Outcomes After Laparoscopic vs Open Adhesiolysis for Small Bowel Obstruction: The LASSO Randomized Clinical Trial. JAMA Surg. 2026 Apr 1;161(4):381-388. doi: 10.1001/jamasurg.2025.6726.
PubMed 41706492Sallinen V, Wikstrom H, Victorzon M, Salminen P, Koivukangas V, Haukijarvi E, Enholm B, Leppaniemi A, Mentula P. Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial. BMC Surg. 2014 Oct 11;14:77. doi: 10.1186/1471-2482-14-77.
PubMed 25306234
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Adhesiolysis for Small Bowel Obstruction - A Multicenter, Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01867528
- Acronym / sponsor ID
- HUCH-95-150513
- Conditions
- Adhesive Small Bowel Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- May 2018 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic adhesiolysis | Experimental | Procedure: Laparoscopic adhesiolysis |
| Open adhesiolysis | Active comparator | Procedure: Open adhesiolysis |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic adhesiolysis | Procedure or surgery | Laparoscopic adhesiolysis |
| Open adhesiolysis | Procedure or surgery | Open adhesiolysis |
Primary outcome
Post-operative hospital stay (days)
Time frame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
13 secondary outcomes
Passage of stools (post-operative days)
Time frame: 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)
Time frame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Mortality
Time frame: 30 days after randomization
Complications, Clavien-Dindo classification
Time frame: 30 days after randomization
Number of participants with iatrogenic small bowel lesions
Time frame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Number of participants with readmission(s)
Time frame: 30 days after randomization
Number of participant with failure to relieve obstruction
Time frame: 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
Time frame: Postoperative days 1- 7 or till discharge
Length of epidural catheter analgesia (days)
Time frame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Total need of opioids in milligrams
Time frame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Length of sick leave (days)
Time frame: Participants will be followed for the duration of sick leave, depending on occupation estimated 1-4 weeks
Number of participants that develop ventral hernia
Time frame: 10 years
Number of patient with recurrent adhesive small bowel obstruction
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Derived from this study: PubMed 41706492Raty P, Mentula P, Haukijarvi E, Juusela R, Wikstrom H, Koivukangas V, Enholm B, Di Saverio S, Birindelli A, Catena F, Leppaniemi A, Sallinen V. Long-Term Outcomes After Laparoscopic vs Open Adhesiolysis for Small Bowel Obstruction: The LASSO Randomized Clinical Trial. JAMA Surg. 2026 Apr 1;161(4):381-388. doi: 10.1001/jamasurg.2025.6726.
- Derived from this study: PubMed 25306234Sallinen V, Wikstrom H, Victorzon M, Salminen P, Koivukangas V, Haukijarvi E, Enholm B, Leppaniemi A, Mentula P. Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial. BMC Surg. 2014 Oct 11;14:77. doi: 10.1186/1471-2482-14-77.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ville Sallinen, MD, PhD principal investigator
Helsinki University Central Hospital
Panu Mentula, MD, PhD study director
Helsinki University Central Hospital
Ari Leppäniemi, MD, PhD study chair
Helsinki University Central Hospital
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic adhesiolysis and Open adhesiolysis in people with Adhesive Small Bowel Obstruction, run by Helsinki University Central Hospital at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Finland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative hospital stay (days) (time frame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01867528, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.