Breast NeoplasmsNCT04676438
Persistant Post-mastectomy Pain in Breast Cancer : Incidence and Risk Factors
An observational study of Breast Neoplasms and Pain, Postoperative, run by Moroccan Society of Surgery at 2 sites in Morocco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Pain, Postoperative, Pain, Chronic
- How many people
- 722 participants
- Where
- 2 sitesMorocco
- Study dates
- 10 Dec 2018to 7 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergo breast surgery at National Institute of Oncology (Sheikha Fatma center)
Who may be able to join
- Willingness and ability to sign an informed consent document
- More than 18 years of age
- All American Society of Anesthesiology classes
- Patient undergo for breast surgery
Who cannot join
- Patients who expressed their refusal to participate in the study
- Patients unable to express their non-opposition to participating in the study
Trial locations and contacts
2 sites in 1 country.
Morocco2 sites
National Institute of Oncology of Rabat
Rabat, 10170
National Institut of Oncology, Surgical oncology department
Rabat
About this study
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
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.
Read the 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
- Conditions
- Breast Neoplasms, Pain, Postoperative, Pain, Chronic
- Keywords
- Breast Neoplasms, Pain, Postoperative, Mastectomy and pain syndrome
- Medical subject headings
- Breast Neoplasms, Pain, Postoperative, Chronic Pain, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving surgery breast surgery for cancer at National Institute of Oncology | No intervention will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-mastectomy pain
Assessed via breast pain questionnaire, including severity, frequency, related symptoms, and functional impairment
Measured: preoperative-3months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start10 Dec 2018
- Primary completion8 Sep 2020
- Study completion7 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moroccan Society of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amine Souadka, Moroccan Society of Surgery
- Investigators
- Abdelilah Ghannam, MD, Principal investigator, Mohammed V University in Rabat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676438
- Sponsor's protocol ID
- PPMP_INO
- Status last verified
- Jul 2021
- First submitted
- 15 Dec 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04676438
- Acronym / sponsor ID
- PPMP_INO
- Conditions
- Breast Neoplasms, Pain, Postoperative, Pain, Chronic
- Keywords
- Breast Neoplasms, Pain, Postoperative, Mastectomy and pain syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- Moroccan Society of SurgeryUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 7 Mar 2021 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving surgery breast surgery for cancer at National Institute of Oncology | – | –No intervention will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergo breast surgery at National Institute of Oncology (Sheikha Fatma center)
Key inclusion criteria (4 listed)
- Willingness and ability to sign an informed consent document
- More than 18 years of age
- All American Society of Anesthesiology classes
- Patient undergo for breast surgery
Key exclusion criteria (2 listed)
- Patients who expressed their refusal to participate in the study
- Patients unable to express their non-opposition to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-mastectomy pain
Time frame: preoperative-3months postoperative
Assessed via breast pain questionnaire, including severity, frequency, related symptoms, and functional impairment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelilah Ghannam, MD principal investigator
Mohammed V University in Rabat
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Pain, Postoperative, run by Moroccan Society of Surgery at 2 sites in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-mastectomy pain (time frame: preoperative-3months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021; AzTrials last refreshed its copy on 7 Nov 2026.