Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain

July 18, 2016 updated by: Marijke Molegraaf, Groene Hart Ziekenhuis

Benefit of Laparoscopic Adhesiolysis

Laparoscopic adhesiolysis as a therapy for chronic pain is still controversial and long term effects are not known. The objective was to to evaluate long term effects of laparoscopic adhesiolysis for treating chronic abdominal pain.

Therefore one hundred patients with abdominal pain attributed to adhesions were randomized to laparoscopic adhesiolysis or a placebo group with laparoscopy alone. Pain relief was assessed after 3, 6 and 12 months and 12-year follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This multi-center randomized controlled trial, included patients with chronic abdominal pain likely to be caused by adhesions from previous abdominal surgery. Chronic abdominal pain was defined as continues or intermittent abdominal pain of at least six months' duration. After excluding other pathology (see exclusion criteria) included patients underwent a diagnostic laparoscopy to confirm the adhesions and to exclude serious morbidity not visible with other diagnostics. If during laparoscopy adhesions were the only pathology present, patients were randomly assigned either to laparoscopic adhesiolysis or no treatment. For the randomization and surgical procedures the investigators refer to the original article. Patients were unaware of their treatment assignment and the outcome assessment was blinded. Abdominal pain and quality of life (QOL) were assessed pre-operatively and at 3, 6 and 12 months of follow-using a visual analog scale (VAS), verbal rating pain change score (VRCS) and the short form 36 (SF-36). After twelve months randomization was disclosed and placebo group patients with persisting abdominal pain could request laparoscopic adhesiolysis. After twelve year follow-up pain, QOL, medical history and analgesic intake were analyzed to assess the long term effects of laparoscopic adhesiolysis.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 years and above with chronic abdominal pain that was likely to be caused by adhesions due to previous abdominal surgery were recruited. Before attributing abdominal pain to the existence of adhesions all patients had an extensional diagnostic work-up to exclude other pathology.

Exclusion Criteria:

  • Current treatment by psychologist or psychiatrist
  • Use of laxatives, sedatives, morphine, antipsychotics, antidepressants, or drugs that stimulate the central nervous system

  • Abnormal outcome of standardized non-invasive diagnostics:

    • Biochemical investigation
    • Lactose tolerance tests or H2 respiration test
    • Feces analysis of worms and worm eggs
    • Ultrasound or CT scan of the abdomen
    • Radiographic studies of small and large bowel (or colonoscopy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adhesiolysis group
Patients underwent laparoscopic adhesiolysis
Procedure: Laparoscopic adhesiolysis
After diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed
Placebo Comparator: Placebo group
Patients underwent diagnostic laparoscopy alone
Procedure: Diagnostic laparoscopy
After diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term pain relief
Time Frame: 12 months
Pain relief was assessed using a verbal rating pain change score (VRCS)
12 months
Long term pain relief
Time Frame: 12 year
Pain relief was assessed using a verbal rating pain change score (VRCS)
12 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 12 months and 12 year
QOL was assessed using the Short Form 36
12 months and 12 year
Complications of treatment
Time Frame: 12 year
12 year
Analgesic intake
Time Frame: 12 months and 12 year
12 months and 12 year
additional surgery because of persisting abdominal pain
Time Frame: 12 months and 12 year
patient questionnaire, patients medical record
12 months and 12 year
rate of consulting medical doctors
Time Frame: 12 months and 12 year
12 months and 12 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groene Hart Ziekenhuis

Collaborators

Erasmus Medical Center
Catharina Ziekenhuis Eindhoven
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Maxima Medical Center
Rijnstate Hospital
Maasstad Hospital
Isala

Investigators

  • Principal Investigator: Dingeman Swank, Dr, Groene Hart Ziekenhuis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1997

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160.613/1997/70

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Study Protocol
    Information comments: Study data can be requested by mailing to mjmolegraaf@gmail.com

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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