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Adhesiolysis in Chronic Abdominal Pain

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ClinicalTrials.gov Identifier: NCT01245023
Recruitment Status : Withdrawn (lack of funding)
First Posted : November 22, 2010
Last Update Posted : January 3, 2013
Sponsor:
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 ]


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01245023


Locations
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, Finland
Sponsors and Collaborators
North Karelia Central Hospital

Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital
ClinicalTrials.gov 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
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive