Adhesiolysis in Chronic Abdominal Pain

This study has been withdrawn prior to enrollment.

(lack of funding)

Sponsor:

Information provided by (Responsible Party):

Sanna Kouhia, North Karelia Central Hospital

ClinicalTrials.gov Identifier:

NCT01245023

First received: November 19, 2010

Last updated: December 31, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 19, 2010
Last Updated Date	December 31, 2012
Start Date ^ICMJE	January 2014
Estimated Primary Completion Date	December 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 19, 2010)	pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01245023 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Adhesiolysis in Chronic Abdominal Pain
Official Title ^ICMJE	Laparoscopic Adhesiolysis in Treatment of Chronic Abdominal Pain - a Prospective Randomized Trial
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Chronic Abdominal Pain
Intervention ^ICMJE	Procedure: Laparoscopic adhesiolysis Laparoscopic adhesiolysis and Sprayshield Procedure: Placebo-surgery skin incisions without laparoscopy or related procedures
Study Arm (s)	Active Comparator: laparoscopy laparoscopic adhesiolysis and application of Sprayshield spray to prevent further adhesions Intervention: Procedure: Laparoscopic adhesiolysis Placebo Comparator: placebo-control anaethesia and skin incisions without laparoscopy or related procedures Intervention: Procedure: Placebo-surgery
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	0
Estimated Completion Date	June 2017
Estimated Primary Completion Date	December 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Finland

Administrative Information
NCT Number ^ICMJE	NCT01245023
Other Study ID Numbers ^ICMJE	NKCH-Surg-007
Has Data Monitoring Committee	No
Responsible Party	Sanna Kouhia, North Karelia Central Hospital
Study Sponsor ^ICMJE	North Karelia Central Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	North Karelia Central Hospital
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top