Surgical AdhesionsNCT05703451
Prevalence and Severity of Surgical Adhesions Among Women Undergoing Laparoscopic Surgery at Women's Health Hospital
An observational study of Surgical Adhesions, run by Assiut University at 2 sites in Egypt.
Trial summary
To assess the prevalence of surgical adhesions among women undergoing laparoscopy, and the severity of the adhesions according to proposed classification of intra-abdominal adhesions. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Adhesions
- What is being tested?
- laparoscopic surgery
- How many people
- 127 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Feb 2023to 30 Jan 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited from the women at Women's Health Hospital Assuit University that will undergo laparoscopy for any cause
Who may be able to join
- Women who will undergo laparoscopic surgery at Women's Health hospital Assuit University.
- women aged 18 years or more.
Who cannot join
- Women who refused to participate in our study
Trial locations and contacts
2 sites in 1 country.
About this study
To assess the prevalence of surgical adhesions among women undergoing laparoscopy, and the severity of the adhesions according to proposed classification of intra-abdominal adhesions.
Read the detailed description
Patients will be recruited from the women at Women's Health Hospital Assuit University that will undergo laparoscopy for any cause. After the patients has been examined and put on a list for laparoscopy, they will be counselled about our study and its benefits. Written consent will be obtained.
All women will be subjected to the following:
- History taking:
- Personal history: demographic factors and age.
- Obstetric history: parity, last delivery, history of abortion.
- Menstrual history: regular or irregular cycles, P/C.
- Past history: history of chronic diseases such as diabetes or hypertension, endometriosis, chronic pelvic pain and PID.
- Surgical history: of any previous operations including abdomino-pelvic surgery (either laparoscopy or laparotomy) and caesarean section.
- The complain of the patient and the indication of laparoscopy.
- Clinical examination:
- General examination including pulse, blood pressure, temperature, BMI and pallor.
- Abdominal examination for scars of previous operations or fundal level.
- Investigations:
- Ultrasonography: to assess the uterus and adnexa.
- Blood sample: it will be examined for the following; complete blood picture and renal function test.
- During laparoscopy: Any adhesions will be noticed, the prevalence of adhesions will be calculated regarding the age, parity, previous history of miscarriage and past medical history. The prevalence of adhesions will be calculated according to the indication of laparoscopy. The prevalence of adhesions will be compared according to different items. Comparison between patients with no past surgical history and those who have past surgical history. Comparison between patients who have history of ectopic pregnancy and those who have no history of ectopic pregnancy. Comparison between patients with previous caesarean section and patients with previous other abdominopelvic surgery.
- The adhesions will be noticed, its site will be detected (between uterus and bladder, uterus and abd. Fascia, uterus and omentum, omentum and abd. Fascia or adhesions to other pelvic structure that interfere with the delivery), its consistency (Filmy or dense) and thickness (either < 3cm, 3-6cm, or > 6cm) and these informations will be subjected to the proposed classification and every case will have its score. The data will be analysed to find out which cases have high score and their common risk factors that are expected to be the cause of this high score.
- Conditions
- Surgical Adhesions
- Being tested
- laparoscopic surgery
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgeryOther
during laparoscopy Any adhesions will be noticed, the prevalence of adhesions will be calculated regarding the age, parity, previous history of miscarriage and past medical history.
The prevalence of adhesions will be calculated according to the indication of laparoscopy.
The prevalence of adhesions will be compared according to different items. Comparison between patients with no past surgical history and those who have past surgical history.
Comparison between patients who have history of ectopic pregnancy and those who have no history of ectopic pregnancy.
Comparison between patients with previous caesarean section and patients with previous other abdominopelvic surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of surgical adhesions among women undergoing laparoscopic surgery at Women's Health Hospital (prospective cross-sectional study).
the prevalence of surgical adhesions among women undergoing laparoscopy in Women's Health Hospital Assuit University.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical AdhesionsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Shaban Mohammed Farghaly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703451
- Sponsor's protocol ID
- surgical adhesions
- Status last verified
- Apr 2024
- First submitted
- 9 Jan 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aboshama RA, Taha OT, Abdel Halim HW, Elrehim EIA, Kamal SHM, ElSherbiny AM, Magdy HA, Albayadi E, Elsaid RE, Abdelghany AM, Anan MA, Abdelfattah LE. Prevalence and risk factor of postoperative adhesions following repeated cesarean section: A prospective cohort study. Int J Gynaecol Obstet. 2023 Apr;161(1):234-240. doi: 10.1002/ijgo.14498. Epub 2022 Oct 26.
PubMed 36200671
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Severity of Surgical Adhesions Among Women Undergoing Laparoscopic Surgery at Women's Health Hospital
- ClinicalTrials.gov ID
- NCT05703451
- Acronym / sponsor ID
- surgical adhesions
- Conditions
- Surgical Adhesions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 30 Jan 2023 (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.
To assess the prevalence of surgical adhesions among women undergoing laparoscopy, and the severity of the adhesions according to proposed classification of intra-abdominal adhesions.
Detailed description
Patients will be recruited from the women at Women's Health Hospital Assuit University that will undergo laparoscopy for any cause. After the patients has been examined and put on a list for laparoscopy, they will be counselled about our study and its benefits. Written consent will be obtained.
All women will be subjected to the following:
- History taking:
- Personal history: demographic factors and age.
- Obstetric history: parity, last delivery, history of abortion.
- Menstrual history: regular or irregular cycles, P/C.
- Past history: history of chronic diseases such as diabetes or hypertension, endometriosis, chronic pelvic pain and PID.
- Surgical history: of any previous operations including abdomino-pelvic surgery (either laparoscopy or laparotomy) and caesarean section.
- The complain of the patient and the indication of laparoscopy.
- Clinical examination:
- General examination including pulse, blood pressure, temperature, BMI and pallor.
- Abdominal examination for scars of previous operations or fundal level.
- Investigations:
- Ultrasonography: to assess the uterus and adnexa.
- Blood sample: it will be examined for the following; complete blood picture and renal function test.
- During laparoscopy: Any adhesions will be noticed, the prevalence of adhesions will be calculated regarding the age, parity, previous history of miscarriage and past medical history. The prevalence of adhesions will be calculated according to the indication of laparoscopy. The prevalence of adhesions will be compared according to different items. Comparison between patients with no past surgical history and those who have past surgical history. Comparison between patients who have history of ectopic pregnancy and those who have no history of ectopic pregnancy. Comparison between patients with previous caesarean section and patients with previous other abdominopelvic surgery.
- The adhesions will be noticed, its site will be detected (between uterus and bladder, uterus and abd. Fascia, uterus and omentum, omentum and abd. Fascia or adhesions to other pelvic structure that interfere with the delivery), its consistency (Filmy or dense) and thickness (either < 3cm, 3-6cm, or > 6cm) and these informations will be subjected to the proposed classification and every case will have its score. The data will be analysed to find out which cases have high score and their common risk factors that are expected to be the cause of this high score.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the women at Women's Health Hospital Assuit University that will undergo laparoscopy for any cause
Key inclusion criteria (2 listed)
- Women who will undergo laparoscopic surgery at Women's Health hospital Assuit University.
- women aged 18 years or more.
Key exclusion criteria (1 listed)
- Women who refused to participate in our study
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 |
|---|---|---|
| laparoscopic surgeryduring laparoscopy Any adhesions will be noticed, the prevalence of adhesions will be calculated regarding the age, parity, previous history of miscarriage and past medical history. The prevalence of adhesions will be calculated according to the indication of laparoscopy. The prevalence of adhesions will be compared according to different items. Comparison between patients with no past surgical history and those who have past surgical history. Comparison between patients who have history of ectopic pregnancy and those who have no history of ectopic pregnancy. Comparison between patients with previous caesarean section and patients with previous other abdominopelvic surgery. | Other | – |
Primary outcome
Prevalence of surgical adhesions among women undergoing laparoscopic surgery at Women's Health Hospital (prospective cross-sectional study).
Time frame: baseline
the prevalence of surgical adhesions among women undergoing laparoscopy in Women's Health Hospital Assuit University.
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 30 Apr 2024.
- Background: PubMed 36200671Aboshama RA, Taha OT, Abdel Halim HW, Elrehim EIA, Kamal SHM, ElSherbiny AM, Magdy HA, Albayadi E, Elsaid RE, Abdelghany AM, Anan MA, Abdelfattah LE. Prevalence and risk factor of postoperative adhesions following repeated cesarean section: A prospective cohort study. Int J Gynaecol Obstet. 2023 Apr;161(1):234-240. doi: 10.1002/ijgo.14498. Epub 2022 Oct 26.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgical Adhesions, run by Assiut University at 2 sites 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 2 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 30 Apr 2024. 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 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?
Prevalence of surgical adhesions among women undergoing laparoscopic surgery at Women's Health Hospital (prospective cross-sectional study). (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05703451, which also lists 1 linked publication.
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 30 Apr 2024.