Gynecological SurveyGPHNCT03606772
Gynecological Presentations Following Supracervical Hysterectomy
An observational study of Gynecological Survey, run by Tanta University at 1 site in Egypt.
Trial summary
Supracervical hysterectomy is widely common and had many complications either immediate or delayed. In these patients bleeding, infection, chronic pelvic pain are common. In these patients cervical biopsy will be done and histopathological examinations will be done to evaluate the pathology in these patients. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Gynecological Survey
- What is being tested?
- Questionanniare
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 31 Mar 2019
- How long will I take part?
- 15 Days
- 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 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: • Patients: 1280 patients with hysterectomy recruited at Tanta University Hospital, gynecology clinics in central hospitals in Gharbia governorate
Who may be able to join
- Hysterectomy for benign pathologies
Who cannot join
- Hysterectomy for malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gynecological Presentations and Pelvic Symptoms Following Supracervical Hysterectomy for Benign Pathologies: A Survey Study
Supracervical hysterectomy is widely common and had many complications either immediate or delayed. In these patients bleeding, infection, chronic pelvic pain are common. In these patients cervical biopsy will be done and histopathological examinations will be done to evaluate the pathology in these patients.
Read the detailed description
- Study design and settings: Cross sectional descriptive studies
- Patients: 130 patients with hysterectomy recruited at Tanta University Hospital, gynecology clinics in central hospitals in Gharbia governorate will be recruited according inclusion and exclusion criteria. Inclusion criteria include all symptomatizing patients following supracervical hysterectomy, of any age, of any complaints. The
- Methods: All patients' demographic data, history, indication of hysterectomy, duration since operation, postoperative complications and their main complaint.
- Conditions
- Gynecological Survey
- Being tested
- Questionanniare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionanniareOther
Also called Pelvic examination
Filling printed questionnaire + Pelvic examination
| Study group | Role | What they receive |
|---|---|---|
| supracervical hysterectomy | Patients operated abdominal by removal of uterus, with removal of tubes and ovaries and retaining of cervix Receives: Other: Questionanniare |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participant with gynecological symptoms following hysterectomy
Symptoms occurring after hysterectomy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Aug 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological SurveyStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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
- Cross-sectional
- Enrolment
- 130 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
- Investigators
- Ayman Dawood, Principal investigator, Lecturer at Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606772
- Sponsor's protocol ID
- GPHysterectomy
- Acronym
- GPH
- Status last verified
- Jun 2019
- First submitted
- 22 Jul 2018
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients data are not allowed to be public
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynecological Presentations and Pelvic Symptoms Following Supracervical Hysterectomy for Benign Pathologies: A Survey Study
- ClinicalTrials.gov ID
- NCT03606772
- Acronym / sponsor ID
- GPH / GPHysterectomy
- Conditions
- Gynecological Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 31 Jul 2018 (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.
Supracervical hysterectomy is widely common and had many complications either immediate or delayed. In these patients bleeding, infection, chronic pelvic pain are common. In these patients cervical biopsy will be done and histopathological examinations will be done to evaluate the pathology in these patients.
Detailed description
- Study design and settings: Cross sectional descriptive studies
- Patients: 130 patients with hysterectomy recruited at Tanta University Hospital, gynecology clinics in central hospitals in Gharbia governorate will be recruited according inclusion and exclusion criteria. Inclusion criteria include all symptomatizing patients following supracervical hysterectomy, of any age, of any complaints. The
- Methods: All patients' demographic data, history, indication of hysterectomy, duration since operation, postoperative complications and their main complaint.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| supracervical hysterectomy | – | Other: QuestionanniarePatients operated abdominal by removal of uterus, with removal of tubes and ovaries and retaining of cervix |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- • Patients: 1280 patients with hysterectomy recruited at Tanta University Hospital, gynecology clinics in central hospitals in Gharbia governorate
Key inclusion criteria (1 listed)
- Hysterectomy for benign pathologies
Key exclusion criteria (1 listed)
- Hysterectomy for malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionanniareAlso: Pelvic examinationFilling printed questionnaire + Pelvic examination | Other | supracervical hysterectomy |
Primary outcome
number of participant with gynecological symptoms following hysterectomy
Time frame: 6 months
Symptoms occurring after hysterectomy
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 12 Jun 2019.
- Individual participant dataSharing planned: No. Patients data are not allowed to be public
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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.
Ayman Dawood principal investigator
Lecturer at Tanta University
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 Gynecological Survey, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 1 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 12 Jun 2019. 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 Egypt. 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?
number of participant with gynecological symptoms following hysterectomy (time frame: 6 months). 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 12 Jun 2019.