atural course of Pain following surgery through an Abdominal INcision: The Role of Adhesions and other factors in Chronification of abdominal pai

Recruiting

Conditions: chronic pain
peritoneal adhesions
10018012
10017998

Registration Number: NL-OMON49406

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1500

Inclusion Criteria

Phase 1, initial inclusion:
- Adult patients, 18 years
- scheduled for elective abdominal surgery (e.g. laparotomy or laparoscopy), In
phase 2 of the study (cineMRI) we will select a subgroup of the original cohort
meeting these additional criteria:
- Chronic pain at 12 months post-operative as defined by International
Association for Study of Pain (IASP) criteria:
- Daily pain in the past three months
- Pain is continues or intermittent
- Pain scores for the worst pain are 4 or higher
- patient has developed abdominal pain related to the surgical procedure
OR
- patients without chronic pain who are matched for type of surgery and risk
factors for developing chronic pain.

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Mental incompetence
- Planned for laparoscopic cholecystectomy
- Planned for Caesarean section, Additional exclusion criteria for phase two
are:
- Contra-indications for MRI (without contrast) including:
- Severe claustrophobia
- Metal splinters in eyes
- Cerebral vascular clips
- Electronic medical implants
- Patient who does not want to be informed about potential incidental findings
of MRI-scan

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study outcome for phase one is the median and range of duration (days) of<br /><br>abdominal pain during rest and during daily activities following abdominal<br /><br>surgery.<br /><br>Main outcomes for phase two is the percentage of patients with adhesions on<br /><br>cineMRI as compared between patients with and without chronic pain. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are predictive factors for development of pain,<br /><br>health-related quality of life, healthcare utilization, and return to daily<br /><br>activity or work. Predictors will be used to model a prediction model using<br /><br>regression techniques.<br /><br>Secondary outcomes for phase 2 relate to the appearance of adhesions on<br /><br>cineMRI, and included extent and the loss of shear.</p><br>