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WithdrawnNCT01245023Updated Jan 3, 2013

Adhesiolysis in Chronic Abdominal Pain

An interventional study of Laparoscopic adhesiolysis and Placebo-surgery in Chronic Abdominal Pain, sponsored by North Karelia Central Hospital. Withdrawn at 6 sites in Finland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-01-03.

Sponsored by North Karelia Central Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
lack of funding
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Chronic Abdominal Pain

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03

In context

Abdominal Pain

338 studies on the registry are indexed under Abdominal Pain; 55 are open to participants now.

Browse Abdominal Pain studies →

Lead sponsor

North Karelia Central Hospital is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    laparoscopy

    laparoscopic adhesiolysis and application of Sprayshield spray to prevent further adhesions

    Procedure: Laparoscopic adhesiolysis

  • Placebo comparator
    placebo-control

    anaethesia and skin incisions without laparoscopy or related procedures

    Procedure: Placebo-surgery

Interventions

  • ProcedureLaparoscopic adhesiolysis

    Laparoscopic adhesiolysis and Sprayshield

  • ProcedurePlacebo-surgery

    skin incisions without laparoscopy or related procedures

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What researchers measure

Primary outcomes

  1. pain

    Time frame: 6 months

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Study locations

6 sites
  • 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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01245023
Lead sponsor
North Karelia Central Hospital
Responsible party
Sanna Kouhia (MD, North Karelia Central Hospital) — Principal investigator
First posted
Nov 22, 2010
Start date
Jan 2014
Primary completion
Dec 2016 (estimated)
Completion
Jun 2017 (estimated)
Last update
Jan 3, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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