Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain

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

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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