NCT01245023

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
3.1 years until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

2.9 years

First QC Date

November 19, 2010

Last Update Submit

December 31, 2012

Conditions

Chronic Abdominal Pain

Outcome Measures

Primary Outcomes (1)

  • pain

    6 months

Study Arms (2)

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

Laparoscopic adhesiolysisPROCEDURE

Laparoscopic adhesiolysis and Sprayshield

laparoscopy
Placebo-surgeryPROCEDURE

skin incisions without laparoscopy or related procedures

placebo-control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • psychiatric disorder
  • significant other somatic diseases (ASA class III-V)
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kainuu Central Hospital

Kajaani, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Mikkeli Central Hospital

Mikkeli, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Pieksämäki district hospital

Pieksämäki, Finland

Location

Turku University Hospital

Turku, Finland

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 22, 2010

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations

FI(6)