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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05703451
Collaborator
(none)
110
22.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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:

  2. Personal history: demographic factors and age.

  3. Obstetric history: parity, last delivery, history of abortion.

  4. Menstrual history: regular or irregular cycles, P/C.

  5. Past history: history of chronic diseases such as diabetes or hypertension, endometriosis, chronic pelvic pain and PID.

  6. Surgical history: of any previous operations including abdomino-pelvic surgery (either laparoscopy or laparotomy) and caesarean section.

  7. The complain of the patient and the indication of laparoscopy.

  8. Clinical examination:

  • General examination including pulse, blood pressure, temperature, BMI and pallor.

  • Abdominal examination for scars of previous operations or fundal level.

  1. Investigations:
  • Ultrasonography: to assess the uterus and adnexa.

  • Blood sample: it will be examined for the following; complete blood picture and renal function test.

  1. 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.

  1. 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

Study Type:
Observational
Anticipated Enrollment :
110 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Prevalence and Severity of Surgical Adhesions Among Women Undergoing Laparoscopic Surgery at Women's Health Hospital
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Outcome Measures

Primary Outcome Measures

  1. Prevalence of surgical adhesions among women undergoing laparoscopic surgery at Women's Health Hospital (prospective cross-sectional study). [baseline]

    the prevalence of surgical adhesions among women undergoing laparoscopy in Women's Health Hospital Assuit University.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mahmoud Shaban Mohammed Farghaly, resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05703451
Other Study ID Numbers:
  • surgical adhesions
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2023