Adhesiolysis in Chronic Abdominal Pain

NCT ID: NCT01245023

Last Updated: 2013-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Abdominal Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

laparoscopy

laparoscopic adhesiolysis and application of Sprayshield spray to prevent further adhesions

Group Type ACTIVE_COMPARATOR

Laparoscopic adhesiolysis

Intervention Type PROCEDURE

Laparoscopic adhesiolysis and Sprayshield

placebo-control

anaethesia and skin incisions without laparoscopy or related procedures

Group Type PLACEBO_COMPARATOR

Placebo-surgery

Intervention Type PROCEDURE

skin incisions without laparoscopy or related procedures

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopic adhesiolysis

Laparoscopic adhesiolysis and Sprayshield

Intervention Type PROCEDURE

Placebo-surgery

skin incisions without laparoscopy or related procedures

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

North Karelia Central Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sanna Kouhia

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kainuu Central Hospital

Kajaani, , Finland

Site Status

Kuopio University Hospital

Kuopio, , Finland

Site Status

Mikkeli Central Hospital

Mikkeli, , Finland

Site Status

Oulu University Hospital

Oulu, , Finland

Site Status

Pieksämäki district hospital

Pieksämäki, , Finland

Site Status

Turku University Hospital

Turku, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NKCH-Surg-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Damage Control Laparotomy
NCT02706041 COMPLETED NA