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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Helsinki University Central Hospital
Sponsor:
Information provided by (Responsible Party):
Ville Sallinen, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01867528
First received: May 26, 2013
Last updated: May 17, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Adhesive Small Bowel Obstruction
Procedure: Laparoscopic adhesiolysis
Procedure: Open adhesiolysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Versus Open Adhesiolysis for Small Bowel Obstruction - A Multicenter, Prospective, Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • 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 ]
  • Mortality [ Time Frame: 30 days after randomization ]
  • Complications, Clavien-Dindo classification [ Time Frame: 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 ]
  • Number of participants with readmission(s) [ Time Frame: 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 ]
  • Pain scores on the Visual Analog Scale [ Time Frame: 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 ]
  • 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 ]
  • Length of sick leave (days) [ Time Frame: 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 ]
  • Number of patient with recurrent adhesive small bowel obstruction [ Time Frame: 10 years ]

Estimated Enrollment: 102
Study Start Date: July 2013
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic adhesiolysis Procedure: Laparoscopic adhesiolysis
Active Comparator: Open adhesiolysis Procedure: Open adhesiolysis

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01867528

Contacts
Contact: Ville Sallinen, MD, PhD +35894711 ville.sallinen@hus.fi

Locations
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland
Contact: Ville Sallinen       ville.sallinen@hus.fi   
Contact: Panu Mentula       panu.mentula@hus.fi   
Principal Investigator: Ville Sallinen         
Sub-Investigator: Ari Leppäniemi         
Sub-Investigator: Panu Mentula         
Kuopio University Hospital Not yet recruiting
Kuopio, Finland
Contact: Imre Ilves       imre.ilves@kuh.fi   
Principal Investigator: Imre Ilves         
Päijät-Häme Central Hospital Recruiting
Lahti, Finland
Contact: Jyrki Kössi       jyrki.kossi@phsotey.fi   
Principal Investigator: Jyrki Kössi         
Oulu University Hospital Recruiting
Oulu, Finland
Contact: Vesa Koivukangas       vesa.koivukangas@ppshp.fi   
Principal Investigator: Vesa Koivukangas         
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Eija Haukijärvi       eija.haukijarvi@pshp.fi   
Principal Investigator: Eija Haukijärvi         
Turku University Hospital Recruiting
Turku, Finland
Contact: Paulina Salminen       paulina.salminen@tyks.fi   
Principal Investigator: Paulina Salminen         
Vaasa Central Hospital Recruiting
Vaasa, Finland
Contact: Mikael Victorzon       mikael.victorzon@vshp.fi   
Principal Investigator: Mikael Victorzon         
Peijas Hospital Recruiting
Vantaa, Finland
Contact: Heidi Wikström       heidi.wikstrom@hus.fi   
Principal Investigator: Heidi Wikström         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Ville Sallinen, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01867528     History of Changes
Other Study ID Numbers: HUCH-95-150513
Study First Received: May 26, 2013
Last Updated: May 17, 2014
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014