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

Adhesive Small Bowel Obstruction Clinical Trial

Official title:

Laparoscopic Versus Open Adhesiolysis for Small Bowel Obstruction - A Multicenter, Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01867528
• Other study ID #: HUCH-95-150513
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2013

Study information

• Verified date: June 2018
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. primary completion date: May 2018
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Small Bowel Obstruction
• Intestinal Obstruction

Intervention

Procedure:
• Laparoscopic adhesiolysis

• Open adhesiolysis

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Päijät-Häme Central Hospital	Lahti
Finland	Oulu University Hospital	Oulu
Finland	Tampere University Hospital	Tampere
Finland	Vaasa Central Hospital	Vaasa
Finland	Peijas Hospital	Vantaa
Italy	Bologna Maggiore Hospital	Bologna
Italy	Parma University Hospital	Parma

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Countries where clinical trial is conducted

Finland,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative hospital stay (days)		Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Secondary	Passage of stools (post-operative days)		Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Secondary	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
Secondary	Mortality		30 days after randomization
Secondary	Complications, Clavien-Dindo classification		30 days after randomization
Secondary	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
Secondary	Number of participants with readmission(s)		30 days after randomization
Secondary	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
Secondary	Pain scores on the Visual Analog Scale		Postoperative days 1- 7 or till discharge
Secondary	Length of epidural catheter analgesia (days)		Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Secondary	Total need of opioids in milligrams		Participants will be followed for the duration of post-operative hospital stay, an expected average of 7 days
Secondary	Length of sick leave (days)		Participants will be followed for the duration of sick leave, depending on occupation estimated 1-4 weeks
Secondary	Number of participants that develop ventral hernia		10 years
Secondary	Number of patient with recurrent adhesive small bowel obstruction		10 years