Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain

Chronic Pain Clinical Trial

Official title:

Benefit of Laparoscopic Adhesiolysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839564
• Other study ID #: 160.613/1997/70
• Status: Completed
• Phase: Phase 4
• First received: July 14, 2016
• Last updated: July 18, 2016
• Start date: August 1997
• Est. completion date: January 2014

Study information

• Verified date: July 2016
• Source: Groene Hart Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Adhesions
• Chronic Pain

Intervention

Procedure:
• Laparoscopic adhesiolysis
After diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed
• Diagnostic laparoscopy
After diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Groene Hart Ziekenhuis	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Catharina Ziekenhuis Eindhoven, Erasmus Medical Center, Isala, Maasstad Hospital, Maxima Medical Center, Rijnstate Hospital

References & Publications (1)

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. Erratum in: La — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short term pain relief	Pain relief was assessed using a verbal rating pain change score (VRCS)	12 months	No
Primary	Long term pain relief	Pain relief was assessed using a verbal rating pain change score (VRCS)	12 year	No
Secondary	Quality of life	QOL was assessed using the Short Form 36	12 months and 12 year	No
Secondary	Complications of treatment		12 year	Yes
Secondary	Analgesic intake		12 months and 12 year	No
Secondary	additional surgery because of persisting abdominal pain	patient questionnaire, patients medical record	12 months and 12 year	No
Secondary	rate of consulting medical doctors		12 months and 12 year	No