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CompletedNCT05703451Updated Apr 30, 2024

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

An observational study in Surgical Adhesions, sponsored by Assiut University. Completed at 2 sites in Egypt. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
127
Ages
18 Years and older
Sex
Female
01

Study 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 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:

  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.
02

Conditions studied

  • Surgical Adhesions

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03

In context

Tissue Adhesions

244 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.

This study's enrollment of 127 is below the median of 146 across 51 observational studies indexed under Tissue Adhesions.

Browse Tissue Adhesions studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

women aged 18 years or more.

Exclusion criteria

Exclusion Criteria:

  • Women who refused to participate in our study
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
127 participants (actual)
Patient registry
No

Interventions

  • Otherlaparoscopic 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

07

Study locations

2 sites
  • Assiut University
    Asyut, Egypt
  • Women's Health Hospital
    Asyut, Egypt
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05703451
Lead sponsor
Assiut University
Responsible party
Mahmoud Shaban Mohammed Farghaly (resident doctor, Assiut University) — Principal investigator
First posted
Jan 30, 2023
Start date
Feb 1, 2023
Primary completion
Jan 1, 2024
Completion
Jan 30, 2024
Last update
Apr 30, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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