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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention
Chronic Abdominal Pain
Procedure: Laparoscopic adhesiolysis
Procedure: Placebo-surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Laparoscopic Adhesiolysis in Treatment of Chronic Abdominal Pain - a Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by North Karelia Central Hospital:

Primary Outcome Measures:
  • pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sanna Kouhia, MD, North Karelia Central Hospital
ClinicalTrials.gov Identifier: NCT01245023     History of Changes
Other Study ID Numbers: NKCH-Surg-007
Study First Received: November 19, 2010
Last Updated: December 31, 2012
Health Authority: Finland: North Karelia Central Hospital

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on August 28, 2014