Adhesiolysis in Chronic Abdominal Pain

Chronic Abdominal Pain Clinical Trial

Official title:

Laparoscopic Adhesiolysis in Treatment of Chronic Abdominal Pain - a Prospective Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01245023
• Other study ID #: NKCH-Surg-007
• Status: Withdrawn
• Phase: N/A
• First received: November 19, 2010
• Last updated: December 31, 2012
• Start date: January 2014
• Est. completion date: June 2017

Study information

• Verified date: December 2012
• Source: North Karelia Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: North Karelia Central Hospital
• Study type: Interventional

Clinical Trial Summary

Laparoscopic adhesiolysis has been used in treatment of chronic abdominal pain. There has been only one previous controlled study, that stated laparoscopy alone had the same benefits than laparoscopic adhesiolysis. The aim of this study is to compare laparoscopic adhesiolysis with a placebo-procedure in chronic abdominal pain.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65 years

• abdominal pain at least 6 months

• previous abdominal surgery and/or significant abdominal trauma and/or abdominal infection

• ASA class I-II

Exclusion Criteria:

• psychiatric disorder

• significant other somatic diseases (ASA class III-V)

• refusal to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Chronic Abdominal Pain

Intervention

Procedure:
• Laparoscopic adhesiolysis
Laparoscopic adhesiolysis and Sprayshield
• Placebo-surgery
skin incisions without laparoscopy or related procedures

Locations

Country	Name	City	State
Finland	Kainuu Central Hospital	Kajaani
Finland	Kuopio University Hospital	Kuopio
Finland	Mikkeli Central Hospital	Mikkeli
Finland	Oulu University Hospital	Oulu
Finland	Pieksämäki district hospital	Pieksämäki
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
North Karelia Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain		6 months	No