search
Back to results

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

Primary Purpose

Adhesive Small Bowel Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Laparoscopic adhesiolysis
Open adhesiolysis
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Small Bowel Obstruction

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Helsinki University Central Hospital
  • Päijät-Häme Central Hospital
  • Oulu University Hospital
  • Tampere University Hospital
  • Vaasa Central Hospital
  • Peijas Hospital
  • Bologna Maggiore Hospital
  • Parma University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laparoscopic adhesiolysis

Open adhesiolysis

Arm Description

Outcomes

Primary Outcome Measures

Post-operative hospital stay (days)

Secondary Outcome Measures

Passage of stools (post-operative days)
Commence of enteral nutrition (post-operative days)
Mortality
Complications, Clavien-Dindo classification
Number of participants with iatrogenic small bowel lesions
Number of participants with readmission(s)
Number of participant with failure to relieve obstruction
Pain scores on the Visual Analog Scale
Length of epidural catheter analgesia (days)
Total need of opioids in milligrams
Length of sick leave (days)
Number of participants that develop ventral hernia
Number of patient with recurrent adhesive small bowel obstruction

Full Information

First Posted
May 26, 2013
Last Updated
June 16, 2018
Sponsor
Helsinki University Central Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01867528
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Small Bowel Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (false)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic adhesiolysis
Arm Type
Experimental
Arm Title
Open adhesiolysis
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic adhesiolysis
Intervention Type
Procedure
Intervention Name(s)
Open adhesiolysis
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Mortality
Time Frame
30 days after randomization
Title
Complications, Clavien-Dindo classification
Time Frame
30 days after randomization
Title
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
Title
Number of participants with readmission(s)
Time Frame
30 days after randomization
Title
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
Title
Pain scores on the Visual Analog Scale
Time Frame
Postoperative days 1- 7 or till discharge
Title
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
Title
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
Title
Length of sick leave (days)
Time Frame
Participants will be followed for the duration of sick leave, depending on occupation estimated 1-4 weeks
Title
Number of participants that develop ventral hernia
Time Frame
10 years
Title
Number of patient with recurrent adhesive small bowel obstruction
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ville Sallinen, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Panu Mentula, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ari Leppäniemi, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
Päijät-Häme Central Hospital
City
Lahti
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
Facility Name
Vaasa Central Hospital
City
Vaasa
Country
Finland
Facility Name
Peijas Hospital
City
Vantaa
Country
Finland
Facility Name
Bologna Maggiore Hospital
City
Bologna
Country
Italy
Facility Name
Parma University Hospital
City
Parma
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25306234
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs