Prevalence and Severity of Surgical Adhesions Among Women Undergoing Laparoscopic Surgery at Women's Health Hospital

NCT ID: NCT05703451

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. History taking:

1. Personal history: demographic factors and age.
2. Obstetric history: parity, last delivery, history of abortion.
3. Menstrual history: regular or irregular cycles, P/C.
4. Past history: history of chronic diseases such as diabetes or hypertension, endometriosis, chronic pelvic pain and PID.
5. Surgical history: of any previous operations including abdomino-pelvic surgery (either laparoscopy or laparotomy) and caesarean section.
6. The complain of the patient and the indication of laparoscopy.
2. Clinical examination:

* General examination including pulse, blood pressure, temperature, BMI and pallor.
* Abdominal examination for scars of previous operations or fundal level.
3. Investigations:

* Ultrasonography: to assess the uterus and adnexa.
* Blood sample: it will be examined for the following; complete blood picture and renal function test.
4. 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.
5. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Adhesions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

laparoscopic surgery

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women who will undergo laparoscopic surgery at Women's Health hospital Assuit University.

women aged 18 years or more.

Exclusion Criteria

* Women who refused to participate in our study
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mahmoud Shaban Mohammed Farghaly

resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut University

Asyut, , Egypt

Site Status

Women's Health Hospital

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 36200671 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

surgical adhesions

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.