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

NCT01867528 | Unknown

• 1 other identifier: HUCH-95-150513
• Study Type: interventional
• Target: 102
• Locations: 2 countries
• Sites: 8

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.

Conditions

Adhesive Small Bowel Obstruction

Outcome Measures

Primary Outcomes (1)

• Post-operative hospital stay (days)

  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)

  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

Study Arms (2)

Laparoscopic adhesiolysis

EXPERIMENTAL

Procedure: Laparoscopic adhesiolysis

Open adhesiolysis

ACTIVE COMPARATOR

Procedure: Open adhesiolysis

Interventions

Laparoscopic adhesiolysis PROCEDURE

Laparoscopic adhesiolysis

Open adhesiolysis PROCEDURE

Open adhesiolysis

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (8)

Helsinki University Central Hospital

Helsinki, Finland

Location

Päijät-Häme Central Hospital

Lahti, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Vaasa Central Hospital

Vaasa, Finland

Location

Peijas Hospital

Vantaa, Finland

Location

Bologna Maggiore Hospital

Bologna, Italy

Location

Parma University Hospital

Parma, Italy

Location

Related Publications (1)

• 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.

  PMID: 25306234 DERIVED

Study Officials

• Ville Sallinen, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Panu Mentula, MD, PhD

  Helsinki University Central Hospital

  STUDY DIRECTOR

• Ari Leppäniemi, MD, PhD

  Helsinki University Central Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 26, 2013
• First Posted: June 4, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2018
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

FI (6); IT (2)