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

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: Unknown
• Conditions: Adhesive Small Bowel Obstruction
• Intervention / Treatment: Procedure: Laparoscopic adhesiolysis; Procedure: Open adhesiolysis

• Study Type: Interventional
• Enrollment: 102
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 16 years to 93 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic adhesiolysis	Procedure: Laparoscopic adhesiolysis
Active Comparator: Open adhesiolysis	Procedure: Open adhesiolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-operative hospital stay (days)	Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Passage of stools (post-operative 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)	Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Mortality	30 days after randomization
Complications, Clavien-Dindo classification	30 days after randomization
Number of participants with iatrogenic small bowel lesions	Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Number of participants with readmission(s)	30 days after randomization
Number of participant with failure to relieve obstruction	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	Postoperative days 1- 7 or till discharge
Length of epidural catheter analgesia (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	Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Length of sick leave (days)	Participants will be followed for the duration of sick leave, depending on occupation estimated 1-4 weeks
Number of participants that develop ventral hernia	10 years
Number of patient with recurrent adhesive small bowel obstruction	10 years

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: 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

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: May 26, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): June 4, 2013

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 16, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: HUCH-95-150513