NCT02839564

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 chronic-pain

Timeline
Completed

Started Aug 1997

Longer than P75 for phase_4 chronic-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1997

Completed
16.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

16.4 years

First QC Date

July 14, 2016

Last Update Submit

July 18, 2016

Conditions

Chronic PainAdhesions

Keywords

chronic abdominal painlaparoscopic adhesiolysisplacebo

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Quality of life

    12 months and 12 year

  • Complications of treatment

    12 year

  • Analgesic intake

    12 months and 12 year

  • additional surgery because of persisting abdominal pain

    12 months and 12 year

  • rate of consulting medical doctors

    12 months and 12 year

Study Arms (2)

Adhesiolysis group

EXPERIMENTAL

Patients underwent laparoscopic adhesiolysis

Procedure: Laparoscopic adhesiolysis

Placebo group

PLACEBO COMPARATOR

Patients underwent diagnostic laparoscopy alone

Procedure: Diagnostic laparoscopy

Interventions

Laparoscopic adhesiolysisPROCEDURE

After diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed

Adhesiolysis group
Diagnostic laparoscopyPROCEDURE

After diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped.

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1016/s0140-6736(03)12979-0.

    PMID: 12699951RESULT

MeSH Terms

Conditions

Chronic PainTissue Adhesions

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCicatrixFibrosisPathologic Processes

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Dingeman Swank, Dr

    Groene Hart Ziekenhuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 21, 2016

Study Start

August 1, 1997

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 21, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access