search
Back to results

Adhesiolysis in Chronic Abdominal Pain

Primary Purpose

Chronic Abdominal Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Laparoscopic adhesiolysis
Placebo-surgery
Sponsored by
North Karelia Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Abdominal Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

laparoscopy

placebo-control

Arm Description

laparoscopic adhesiolysis and application of Sprayshield spray to prevent further adhesions

anaethesia and skin incisions without laparoscopy or related procedures

Outcomes

Primary Outcome Measures

pain

Secondary Outcome Measures

Full Information

First Posted
November 19, 2010
Last Updated
December 31, 2012
Sponsor
North Karelia Central Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01245023
Brief Title
Adhesiolysis in Chronic Abdominal Pain
Official Title
Laparoscopic Adhesiolysis in Treatment of Chronic Abdominal Pain - a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funding
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Karelia Central Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Abdominal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopy
Arm Type
Active Comparator
Arm Description
laparoscopic adhesiolysis and application of Sprayshield spray to prevent further adhesions
Arm Title
placebo-control
Arm Type
Placebo Comparator
Arm Description
anaethesia and skin incisions without laparoscopy or related procedures
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic adhesiolysis
Intervention Description
Laparoscopic adhesiolysis and Sprayshield
Intervention Type
Procedure
Intervention Name(s)
Placebo-surgery
Intervention Description
skin incisions without laparoscopy or related procedures
Primary Outcome Measure Information:
Title
pain
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kainuu Central Hospital
City
Kajaani
Country
Finland
Facility Name
Kuopio University Hospital
City
Kuopio
Country
Finland
Facility Name
Mikkeli Central Hospital
City
Mikkeli
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Pieksämäki district hospital
City
Pieksämäki
Country
Finland
Facility Name
Turku University Hospital
City
Turku
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

Adhesiolysis in Chronic Abdominal Pain

We'll reach out to this number within 24 hrs