Clinical trial NCT02839564: Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain
Official title: Benefit of Laparoscopic Adhesiolysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Adhesions
Keywords: chronic abdominal pain
laparoscopic adhesiolysis
placebo
Lead sponsor: Groene Hart Ziekenhuis
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Rijnstate Hospital
name: Maxima Medical Center
name: Catharina Ziekenhuis Eindhoven
name: Maasstad Hospital
name: Isala
First posted: 2016-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Short term pain relief
timeFrame: 12 months
measure: Long term pain relief
timeFrame: 12 year
Secondary outcomes:
measure: Quality of life
timeFrame: 12 months and 12 year
measure: Complications of treatment
timeFrame: 12 year
measure: Analgesic intake
timeFrame: 12 months and 12 year
measure: additional surgery because of persisting abdominal pain
timeFrame: 12 months and 12 year
measure: rate of consulting medical doctors
timeFrame: 12 months and 12 year
Other outcomes:
Locations:
Study officials:
affiliation: Groene Hart Ziekenhuis
name: Dingeman Swank, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swank DJ, Swank-Bordewijk SC, Hop WC, van Erp WF, Janssen IM, Bonjer HJ, Jeekel J. Laparoscopic adhesiolysis in patients with chronic abdominal pain: a blinded randomised controlled multi-centre trial. Lancet. 2003 Apr 12;361(9365):1247-51. doi: 10.1016/s0140-6736(03)12979-0.