Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04676438
Status:
COMPLETED
Last Update Posted:
2021-07-20
First Post:
2020-12-15
Brief Title:
Persistant Post-mastectomy Pain in Breast Cancer Incidence and Risk Factors
Sponsor:
Moroccan Society of Surgery
Organization:
Moroccan Society of Surgery
Study Overview
Official Title:
Incidence and Risk Factors of Chronic Persistant Post-surgical Pain in Oncological Breast Surgery a Prospective Cohort Study in a National Institute of Oncology
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post Mastectomy Pain Syndrome PMPS is a major complication of breast surgery responsible for depression and disability
The project consists of a prospective cohort on patients going for oncological breast surgery at National Institute of Oncology of Rabat
Chronic postoperative pain CPP remains a disturbing and obscure clinical problem which could last for more than 3 months after surgery The aim of present study was to assess the prevalence of CPP investigate its impact on life quality and explore its potential risk factors After informed consent was signed patients receiving surgery under general anesthesia in Peking Union Medical College Hospital and other medical centers participating in this study during 2018 will be included Patients preoperative information will be collected from medical record including basic demographic data primary disease and previous chronic diseases Intraoperative information will be obtained from anesthesia record including surgical scope duration length and location of incisions and blood loss Acute pain will be evaluated in the ward of the department of surgery when an app will be installed on patients mobile phones Our long-term postoperative follow-up would be performed by sending out survey questionnaires via this app in the 4th 8th 16th 32th and 48th weeks after surgery The survey covers questions regarding the intensity characteristic location and impact on daily activities of CPP Information regarding treatment of CPP will also be collected if any All the data gained will be summarized in our database and analyzed
The project consists of a prospective cohort on patients going for oncological breast surgery at National Institute of Oncology of Rabat
Chronic postoperative pain CPP remains a disturbing and obscure clinical problem which could last for more than 3 months after surgery The aim of present study was to assess the prevalence of CPP investigate its impact on life quality and explore its potential risk factors After informed consent was signed patients receiving surgery under general anesthesia in Peking Union Medical College Hospital and other medical centers participating in this study during 2018 will be included Patients preoperative information will be collected from medical record including basic demographic data primary disease and previous chronic diseases Intraoperative information will be obtained from anesthesia record including surgical scope duration length and location of incisions and blood loss Acute pain will be evaluated in the ward of the department of surgery when an app will be installed on patients mobile phones Our long-term postoperative follow-up would be performed by sending out survey questionnaires via this app in the 4th 8th 16th 32th and 48th weeks after surgery The survey covers questions regarding the intensity characteristic location and impact on daily activities of CPP Information regarding treatment of CPP will also be collected if any All the data gained will be summarized in our database and analyzed
Detailed Description:
Type of work This is an observational prospective open data-driven single-center study at the National Institute of Oncology NIO - Mohamed Ben Abdellah Hospital in Rabat affiliated to Mohammed V University in Rabat
The objective of the study we are proposing is to determine the incidence and risk factors of chronic post-surgical pain in oncological breast surgery on the Moroccan population operated on and followed at the Sheikha Fatma Center of the National Institute of Oncology of Rabat
The main objective of the study is to
- Determine the incidence of chronic post-surgical pain in carcinological breast surgery
The secondary objectives are
Determine the clinical characteristics of chronic post-surgical pain and in particular the proportion of neuropathic pain and or post-mastectomy pain syndromes
Identify the preoperative intraoperative and postoperative risk factors of developing chronic post-surgical pain in the Moroccan population
Determine the incidence of acute severe postoperative pain
Determine the characteristics of acute postoperative pain
Identify the risk factors for severe acute postoperative pain
Work flow
The medical care of patients will be free to the responsible practitioners according to the usual practice
Nursing staff will be informed of the study
An investigator will be appointed after training in the protocol He will be independent and not responsible for the nursing activity
Patients eligible for the study will be identified during the pre-anesthetic consultation carried out in the week before surgery
The recorded agreements will be obtained during these consultations
Patients will be included once admitted to the operating room and operated
The data collected is presented in the observation book in the appendix with the definitions of the events and the entry rules
The patients will be followed up and reviewed at 3 months and 6 months in surgery consultation for reassessment and completion of the observation book
The objective of the study we are proposing is to determine the incidence and risk factors of chronic post-surgical pain in oncological breast surgery on the Moroccan population operated on and followed at the Sheikha Fatma Center of the National Institute of Oncology of Rabat
The main objective of the study is to
- Determine the incidence of chronic post-surgical pain in carcinological breast surgery
The secondary objectives are
Determine the clinical characteristics of chronic post-surgical pain and in particular the proportion of neuropathic pain and or post-mastectomy pain syndromes
Identify the preoperative intraoperative and postoperative risk factors of developing chronic post-surgical pain in the Moroccan population
Determine the incidence of acute severe postoperative pain
Determine the characteristics of acute postoperative pain
Identify the risk factors for severe acute postoperative pain
Work flow
The medical care of patients will be free to the responsible practitioners according to the usual practice
Nursing staff will be informed of the study
An investigator will be appointed after training in the protocol He will be independent and not responsible for the nursing activity
Patients eligible for the study will be identified during the pre-anesthetic consultation carried out in the week before surgery
The recorded agreements will be obtained during these consultations
Patients will be included once admitted to the operating room and operated
The data collected is presented in the observation book in the appendix with the definitions of the events and the entry rules
The patients will be followed up and reviewed at 3 months and 6 months in surgery consultation for reassessment and completion of the observation book
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None