Chronic Pelvic PainNCT06584760
Research on the Impact of Chronic Pelvic Pain on Endometriosis
An observational study of Chronic Pelvic Pain and Endometriosis, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
Chronic pelvic pain (CPP) is a common disease with multiple systems and multiple causes. In recent years, the incidence rate of CPP in women has gradually increased. It is a pain symptom that originates from pelvic organs or related structures and lasts for more than 6 months. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Chronic Pelvic Pain, Endometriosis
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients undergoing endometriosis surgery in the gynecology department of the Fourth Affiliated Hospital of Zhejiang University School of Medicine
Who may be able to join
- 18 to 50 years old;
- Endometriosis diagnosed through previous surgery (confirmed solely by visual or histopathological examination), endometriosis discovered through imaging examination, deep infiltrating nodules discovered through palpation or imaging examination, and clinically suspected endometriosis;
- No history of migraine or tension headaches;
- No history of mental illness (such as restless leg syndrome, chronic fatigue syndrome, fibromyalgia, anxiety or panic attacks, depression).
Who cannot join
- Postmenopausal state (spontaneous or surgical);
- Previous hysterectomy and/or bilateral salpingo oophorectomy (prior to preoperative visit);
- The patient or authorizer refuses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Fourth Affiliated Hospital of Zhejiang University School of Medicine, No. N1, Shopping Mall Avenue
Yiwu, Zhejiang, 322000
Jiannan He, +86 13615893226, 8018038@zju.edu.cn
About this study
Chronic pelvic pain (CPP) is a common disease with multiple systems and multiple causes. In recent years, the incidence rate of CPP in women has gradually increased. It is a pain symptom that originates from pelvic organs or related structures and lasts for more than 6 months. It is closely related to gynecological diseases such as endometriosis (EMs), adenomyosis, pelvic inflammatory disease (PID), uterine leiomyoma, residual ovarian syndrome, pelvic venous congestion syndrome (PCS), etc. But its pathophysiology is very complex and still needs further exploration. Recent studies have shown that central sensitization is an important mechanism for the sustained existence of CPP.
Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as preoperative endometriosis related questionnaire surveys such as such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as in vitro detection results such as preoperative venous blood, intraoperative pathological tissue immunohistochemistry, ELISA, transcriptome sequencing in patients with endometriosis.
Read the detailed description
Conduct preoperative and postoperative endometriosis related questionnaire surveys on patients, such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Follow up will be conducted 1-2 months after surgery. Preoperative venous blood from patients with endometriosis and pathological tissue of endometriosis removed during surgery were collected for in vitro testing using immunohistochemistry, ELISA, transcriptome sequencing.
- Conditions
- Chronic Pelvic Pain, Endometriosis
- Keywords
- Chronic pelvic pain, Endometriosis
- Medical subject headings
- Endometriosis
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 |
|---|---|---|
| Endometriosis group | Patients undergoing endometriosis surgery in the gynecology department of the Fourth Affiliated Hospital of Zhejiang University School of Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pelvic pain
Using Simplified McGill Pain Questionnaire (SF-MPQ) for scoring
Measured: Within 3 days before surgery, before leaving the hospital after surgery, postoperative discharge (6 months -3 years)
In vitro detection results
The results of immunohistochemistry, ELISA, and transcriptome sequencing of preoperative venous blood and endometrial tissue excised during surgery in patients with endometriosis
Measured: Venous blood within 3 days before surgery; Endometriosis sample excised during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic PainStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiannan He, Study chair, The Fourth Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584760
- Sponsor's protocol ID
- KY-2024-152
- Status last verified
- Sep 2024
- First submitted
- 26 Aug 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Impact of Chronic Pelvic Pain on Endometriosis
- ClinicalTrials.gov ID
- NCT06584760
- Acronym / sponsor ID
- KY-2024-152
- Conditions
- Chronic Pelvic Pain, Endometriosis
- Keywords
- Chronic pelvic pain, Endometriosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Sep 2024 (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.
Chronic pelvic pain (CPP) is a common disease with multiple systems and multiple causes. In recent years, the incidence rate of CPP in women has gradually increased. It is a pain symptom that originates from pelvic organs or related structures and lasts for more than 6 months. It is closely related to gynecological diseases such as endometriosis (EMs), adenomyosis, pelvic inflammatory disease (PID), uterine leiomyoma, residual ovarian syndrome, pelvic venous congestion syndrome (PCS), etc. But its pathophysiology is very complex and still needs further exploration. Recent studies have shown that central sensitization is an important mechanism for the sustained existence of CPP.
Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as preoperative endometriosis related questionnaire surveys such as such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Explore the relationship between chronic pelvic pain and its postoperative outcomes, as well as in vitro detection results such as preoperative venous blood, intraoperative pathological tissue immunohistochemistry, ELISA, transcriptome sequencing in patients with endometriosis.
Detailed description
Conduct preoperative and postoperative endometriosis related questionnaire surveys on patients, such as Endometriosis Health Profile-30 (EHP-30), Central Sensitivity Inventory (CSI), Simplified McGill Pain Questionnaire (SF-MPQ). Follow up will be conducted 1-2 months after surgery. Preoperative venous blood from patients with endometriosis and pathological tissue of endometriosis removed during surgery were collected for in vitro testing using immunohistochemistry, ELISA, transcriptome sequencing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endometriosis group | – | –Patients undergoing endometriosis surgery in the gynecology department of the Fourth Affiliated Hospital of Zhejiang University School of Medicine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing endometriosis surgery in the gynecology department of the Fourth Affiliated Hospital of Zhejiang University School of Medicine
Key inclusion criteria (4 listed)
- 18 to 50 years old;
- Endometriosis diagnosed through previous surgery (confirmed solely by visual or histopathological examination), endometriosis discovered through imaging examination, deep infiltrating nodules discovered through palpation or imaging examination, and clinically suspected endometriosis;
- No history of migraine or tension headaches;
- No history of mental illness (such as restless leg syndrome, chronic fatigue syndrome, fibromyalgia, anxiety or panic attacks, depression).
Key exclusion criteria (3 listed)
- Postmenopausal state (spontaneous or surgical);
- Previous hysterectomy and/or bilateral salpingo oophorectomy (prior to preoperative visit);
- The patient or authorizer refuses.
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
Chronic pelvic pain
Time frame: Within 3 days before surgery, before leaving the hospital after surgery, postoperative discharge (6 months -3 years)
Using Simplified McGill Pain Questionnaire (SF-MPQ) for scoring
In vitro detection results
Time frame: Venous blood within 3 days before surgery; Endometriosis sample excised during surgery
The results of immunohistochemistry, ELISA, and transcriptome sequencing of preoperative venous blood and endometrial tissue excised during surgery in patients with endometriosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Jiannan He study chair
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pelvic Pain and Endometriosis, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.
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 3 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: opening soon, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiannan He (13615893226, 8018038@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pelvic pain (time frame: Within 3 days before surgery, before leaving the hospital after surgery, postoperative discharge (6 months -3 years)). The study lists 2 primary outcomes in all. 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 5 Sep 2024.