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OpenTrials
Completed

NCT Number: NCT02839564

Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Laparoscopic adhesiolysis

Procedure

After diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed

Diagnostic laparoscopy

Procedure

After diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped.

Primary outcomes

  1. Short term pain relief

    Time frame: 12 months

    Pain relief was assessed using a verbal rating pain change score (VRCS)

  2. Long term pain relief

    Time frame: 12 year

    Pain relief was assessed using a verbal rating pain change score (VRCS)

Secondary outcomes

  1. Quality of life

    Time frame: 12 months and 12 year

    QOL was assessed using the Short Form 36

  2. Complications of treatment

    Time frame: 12 year

  3. Analgesic intake

    Time frame: 12 months and 12 year

  4. additional surgery because of persisting abdominal pain

    Time frame: 12 months and 12 year

    patient questionnaire, patients medical record

  5. rate of consulting medical doctors

    Time frame: 12 months and 12 year

Sponsors and collaborators

Lead sponsor

Groene Hart Ziekenhuis

Other

Collaborators

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

Registry information

Official study title

Benefit of Laparoscopic Adhesiolysis

Important dates

Study start
1997
Primary completion
2014
Study completion
2014
First posted
Jul 21, 2016
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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