Adhesiolysis in Chronic Abdominal Pain

December 31, 2012 updated by: Sanna Kouhia, North Karelia Central Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kajaani, Finland
        • Kainuu Central Hospital
      • Kuopio, Finland
        • Kuopio University Hospital
      • Mikkeli, Finland
        • Mikkeli Central Hospital
      • Oulu, Finland
        • Oulu University Hospital
      • Pieksämäki, Finland
        • Pieksämäki district hospital
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Karelia Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

November 19, 2010

First Submitted That Met QC Criteria

November 19, 2010

First Posted (Estimate)

November 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

December 31, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKCH-Surg-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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