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

Surgical Adhesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05703451
• Other study ID #: surgical adhesions
• Status: Completed
• Start date: February 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 30, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgical Adhesions
• Tissue Adhesions

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut
Egypt	Women's Health Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline