Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain

Benefit of Laparoscopic Adhesiolysis

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Adhesions
• Intervention / Treatment: Procedure: Laparoscopic adhesiolysis; Procedure: Diagnostic laparoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adhesiolysis group; Patients underwent laparoscopic adhesiolysis	Procedure: Laparoscopic adhesiolysis; After diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed
Placebo Comparator: Placebo group; Patients underwent diagnostic laparoscopy alone	Procedure: Diagnostic laparoscopy; After diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short term pain relief	Pain relief was assessed using a verbal rating pain change score (VRCS)	12 months
Long term pain relief	Pain relief was assessed using a verbal rating pain change score (VRCS)	12 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	QOL was assessed using the Short Form 36	12 months and 12 year
Complications of treatment		12 year
Analgesic intake		12 months and 12 year
additional surgery because of persisting abdominal pain	patient questionnaire, patients medical record	12 months and 12 year
rate of consulting medical doctors		12 months and 12 year

Collaborators and Investigators

• Sponsor: Groene Hart Ziekenhuis
• Collaborators: Erasmus Medical Center; Catharina Ziekenhuis Eindhoven; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Maxima Medical Center; Rijnstate Hospital; Maasstad Hospital; Isala
• Investigators: Principal Investigator: Dingeman Swank, Dr, Groene Hart Ziekenhuis

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2003 Jun;361(9376):2250.

Study record dates

Study Major Dates

• Study Start: August 1, 1997
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 14, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: July 18, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: placebo; chronic abdominal pain; laparoscopic adhesiolysis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Chronic Pain; Abdominal Pain
• Other Study ID Numbers: 160.613/1997/70

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Study Data/Documents

1. Study Protocol
   Information comments: Study data can be requested by mailing to mjmolegraaf@gmail.com