Adhesiolysis in Chronic Abdominal Pain | NCT01245023

Studies
Adhesiolysis in Chronic Abdominal Pain

NCT01245023

Sponsor

North Karelia Central Hospital

Status

Withdrawn

Last Update Posted

Jan 3, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Chronic Abdominal Pain

Interventions

Laparoscopic adhesiolysis
Placebo-surgery

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of funding

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Jun 2017Estimated

First Submitted Date

Nov 19, 2010

First Submission Date that Met QC Criteria

Nov 19, 2010

First Posted Date

Nov 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 31, 2012

Last Update Posted Date

Jan 3, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
laparoscopy	Active Comparator	laparoscopic adhesiolysis and application of Sprayshield spray to prevent further adhesions	Procedure: Laparoscopic adhesiolysis
placebo-control	Placebo Comparator	anaethesia and skin incisions without laparoscopy or related procedures	Procedure: Placebo-surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic adhesiolysis	Procedure	Laparoscopic adhesiolysis and Sprayshield	laparoscopy

Measure	Description	Time Frame
pain		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kainuu Central Hospital		Kajaani			Finland
Kuopio University Hospital