Clinical trial NCT01867528: Comparison of Laparoscopic Surgery Versus Open Surgery in the Treatment of Adhesive Small Bowel Obstruction
Official title: Laparoscopic Versus Open Adhesiolysis for Small Bowel Obstruction - A Multicenter, Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Small Bowel Obstruction
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-operative hospital stay (days)
timeFrame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Secondary outcomes:
measure: Passage of stools (post-operative days)
timeFrame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
measure: Commence of enteral nutrition (post-operative days)
timeFrame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
measure: Mortality
timeFrame: 30 days after randomization
measure: Complications, Clavien-Dindo classification
timeFrame: 30 days after randomization
measure: Number of participants with iatrogenic small bowel lesions
timeFrame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
measure: Number of participants with readmission(s)
timeFrame: 30 days after randomization
measure: Number of participant with failure to relieve obstruction
timeFrame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
measure: Pain scores on the Visual Analog Scale
timeFrame: Postoperative days 1- 7 or till discharge
measure: Length of epidural catheter analgesia (days)
timeFrame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
measure: Total need of opioids in milligrams
timeFrame: Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
measure: Length of sick leave (days)
timeFrame: Participants will be followed for the duration of sick leave, depending on occupation estimated 1-4 weeks
measure: Number of participants that develop ventral hernia
timeFrame: 10 years
measure: Number of patient with recurrent adhesive small bowel obstruction
timeFrame: 10 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
city: Vantaa
country: Finland
facility: Peijas Hospital
city: Bologna
country: Italy
facility: Bologna Maggiore Hospital
city: Parma
country: Italy
facility: Parma University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Ville Sallinen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Panu Mentula, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital
name: Ari Leppäniemi, MD, PhD
role: STUDY_CHAIR
References:
citation: Sallinen 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.