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

June 16, 2018 updated by: Ville Sallinen, Helsinki University Central Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Central Hospital
      • Lahti, Finland
        • Päijät-Häme Central Hospital
      • Oulu, Finland
        • Oulu University Hospital
      • Tampere, Finland
        • Tampere University Hospital
      • Vaasa, Finland
        • Vaasa Central Hospital
      • Vantaa, Finland
        • Peijas Hospital
  • Italy
      • Bologna, Italy
        • Bologna Maggiore Hospital
      • Parma, Italy
        • Parma University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Laparoscopic adhesiolysis
Procedure: Laparoscopic adhesiolysis
Active Comparator: Open adhesiolysis
Procedure: Open adhesiolysis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
30 days after randomization
Complications, Clavien-Dindo classification
Time Frame: 30 days after randomization
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
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
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
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
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
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
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
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
10 years
Number of patient with recurrent adhesive small bowel obstruction
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Helsinki University Central Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ville Sallinen, MD, PhD, Helsinki University Central Hospital
  • Study Director: Panu Mentula, MD, PhD, Helsinki University Central Hospital
  • Study Chair: Ari Leppäniemi, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUCH-95-150513

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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