Adhesiolysis in Chronic Abdominal Pain
This study has been withdrawn prior to enrollment.
(lack of funding)
Sponsor:
North Karelia Central Hospital
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
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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
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 May 21, 2013