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Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain

G

Groene Hart Ziekenhuis

Status and phase

Completed
Phase 4

Conditions

Adhesions
Chronic Pain

Treatments

Procedure: Laparoscopic adhesiolysis
Procedure: Diagnostic laparoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT02839564
160.613/1997/70

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

100 participants in 2 patient groups, including a placebo group

Adhesiolysis group
Experimental group
Description:
Patients underwent laparoscopic adhesiolysis
Treatment:
Procedure: Laparoscopic adhesiolysis
Placebo group
Placebo Comparator group
Description:
Patients underwent diagnostic laparoscopy alone
Treatment:
Procedure: Diagnostic laparoscopy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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