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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Adhesions
• Intervention / Treatment: Other: laparoscopic surgery

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:

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.

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

• Study Contact: Name: mahmoud shaban, resident; Phone Number: 01005450572; Email: mahmoudshaban8.ms@gmail.com
• Study Contact Backup: Name: mohammed sayed, prof; Phone Number: 01006801036; Email: Msayed21@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the women at Women's Health Hospital Assuit University that will undergo laparoscopy for any cause

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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. 2022 Oct 6. doi: 10.1002/ijgo.14498. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: surgical adhesions

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No