Adhesiolysis in Chronic Abdominal Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01245023
Recruitment Status : Withdrawn (lack of funding)
First Posted : November 22, 2010
Last Update Posted : January 3, 2013
Information provided by (Responsible Party):
Sanna Kouhia, North Karelia Central Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Abdominal Pain Procedure: Laparoscopic adhesiolysis Procedure: Placebo-surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Laparoscopic Adhesiolysis in Treatment of Chronic Abdominal Pain - a Prospective Randomized Trial
Study Start Date : January 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arm Intervention/treatment
Active Comparator: laparoscopy
laparoscopic adhesiolysis and application of Sprayshield spray to prevent further adhesions
Procedure: Laparoscopic adhesiolysis
Laparoscopic adhesiolysis and Sprayshield

Placebo Comparator: placebo-control
anaethesia and skin incisions without laparoscopy or related procedures
Procedure: Placebo-surgery
skin incisions without laparoscopy or related procedures

Primary Outcome Measures :
  1. pain [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01245023

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, Finland
Sponsors and Collaborators
North Karelia Central Hospital

Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital Identifier: NCT01245023     History of Changes
Other Study ID Numbers: NKCH-Surg-007
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: January 3, 2013
Last Verified: December 2012

Additional relevant MeSH terms:
Abdominal Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive