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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02839564
Other study ID # 160.613/1997/70
Secondary ID
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


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
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