Benefit of Laparoscopic Adhesiolysis in Patients With Chronische Abdominal Pain

NCT02839564 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-07-21

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Laparoscopic adhesiolysis

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

PROCEDURE

Diagnostic laparoscopy

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

Sponsors & Collaborators

  • Erasmus Medical Center

    collaborator OTHER
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER
  • Rijnstate Hospital

    collaborator OTHER
  • Maxima Medical Center

    collaborator OTHER
  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER
  • Maasstad Hospital

    collaborator OTHER
  • Isala

    collaborator OTHER
  • Groene Hart Ziekenhuis

    lead OTHER

Principal Investigators

  • Dingeman Swank, Dr · Groene Hart Ziekenhuis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-08-31
Primary Completion
2014-01-31
Completion
2014-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02839564 on ClinicalTrials.gov