Endometriosis
Conditions
Brief summary
The association between endometriosis, obesity and nesfatin1.
Detailed description
All women in this study were subjected to all of the following: 1. Verbal consent was obtained. 2. History taking: 1. Personal history. 2. Menstrual history. 3. Use of contraception. 4. Use of any hormonal treatment in the three months prior to the laparoscopy. 5. History of infertility and its duration and type. 6. Sexual history. 7. Past history. 3. Complete physical examination: general, abdominal and local gynecological examination. 4. Complete preoperative workout for laparoscopy was done. 5. Laparoscopy was done postmenstrual, during follicular phase. All patients gave an informed consent and were fasting for at least 8 hours prior to the laparoscopy, and general anesthesia was used for all patients. The pelvis and its structures were observed and checked for presence of endometriotic lesions (uterus, tubes, ovaries and ovarian fossae, uterosacral ligaments, Douglas pouch, uterovesical pouch, broad ligaments and lateral pelvic walls). The Endometriotic patients were then classified into stages I-IV according to the revised American Fertility Society scoring system for endometriosis. 6. Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients during the laparoscopy procedure immediately after initial evaluation and before any intervention. 7. Biopsy from lesions suspected as endometriosis was taken during laparoscopy and sent to histopathology for confirmation. 8. The blood samples were centrifuged immediately after their collection at 5000 rpm for 10 min and serum samples were stored at -20 °C until analysis. Patients and Methods -67- 9. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay ELISA technique using commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits, Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals.
Interventions
None listed
Sponsors
Ain Shams Maternity Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women in reproductive age group scheduled for laparoscopy for any indication.
Exclusion criteria
* Women subject to any hormonal therapy in the last 3 months. * Women with chronic endocrine disease like diabetes mellitus. * Women diagnosed with pelvic inflammatory disease (PID). * Severe medical disorder that prohibits the laparoscopic procedure, such as cardiovascular disease and pulmonary disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Nesfatin 1 | 24 hours | Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients during the laparoscopy procedure immediately after initial evaluation and before any intervention.The blood samples were centrifuged immediately after their collection at 5000 rpm for 10 min and serum samples were stored at -20 °C until analysis. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay ELISA technique using commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits, Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals. |
Participant flow
Recruitment details
This study was conducted in Ain Shams University Maternity Hospital, during the period from December 2014 till October 2015. After approval of the research and ethics committee and, sixty patients were admitted to the wards to undergo laparoscopy for various indications and were included in this study.
Participants by arm
| Arm | Count |
|---|---|
| Endometriosis 30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI \<25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2. | 30 |
| Control 30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI \<25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Endometriosis | Control | Total |
|---|---|---|---|
| Age, Continuous | 26.83 years STANDARD_DEVIATION 3.89 | 29.06 years STANDARD_DEVIATION 4.25 | 27.95 years STANDARD_DEVIATION 4.2 |
| body mass index | 25.4 kilograms per squared meter STANDARD_DEVIATION 1.9 | 29.4 kilograms per squared meter STANDARD_DEVIATION 2.86 | 27.4 kilograms per squared meter STANDARD_DEVIATION 3.14 |
| categorization of participants according to body mass index lean | 16 participants | 3 participants | 19 participants |
| categorization of participants according to body mass index obese | 1 participants | 14 participants | 15 participants |
| categorization of participants according to body mass index overweight | 13 participants | 13 participants | 26 participants |
| chronic pelvic pain participants having chronic pelvic pain | 9 participants | 4 participants | 13 participants |
| chronic pelvic pain participants not having chronic pelvic pain | 21 participants | 26 participants | 47 participants |
| duration of infertility | 2 years | 3 years | 2.5 years |
| Dysmenorrhea participants having dysmenorrhea | 27 participants | 11 participants | 38 participants |
| Dysmenorrhea participants not having dysmenorrhea | 3 participants | 19 participants | 22 participants |
| Dyspareunia participants having dyspareunia | 12 participants | 3 participants | 15 participants |
| Dyspareunia participants not having dyspareunia | 18 participants | 27 participants | 45 participants |
| height | 161.73 centimeters STANDARD_DEVIATION 3.99 | 161.16 centimeters STANDARD_DEVIATION 4.33 | 161.45 centimeters STANDARD_DEVIATION 4.14 |
| infertility no infertility | 1 participants | 6 participants | 7 participants |
| infertility primary infertility | 19 participants | 12 participants | 31 participants |
| infertility secondary infertility | 10 participants | 12 participants | 22 participants |
| Menorrhagia participants having menorrhagia | 6 participants | 3 participants | 9 participants |
| Menorrhagia participants not having menorrhagia | 24 participants | 27 participants | 51 participants |
| number of abortions no abortions | 25 participants | 25 participants | 50 participants |
| number of abortions one abortion | 4 participants | 5 participants | 9 participants |
| number of abortions three abortions | 1 participants | 0 participants | 1 participants |
| number of abortions two abortions | 0 participants | 0 participants | 0 participants |
| number of living children no children | 23 participants | 13 participants | 36 participants |
| number of living children one livebirth | 7 participants | 7 participants | 14 participants |
| number of living children three livebirths | 0 participants | 1 participants | 1 participants |
| number of living children two livebirths | 0 participants | 9 participants | 9 participants |
| number of previous cesarean sections none | 22 participants | 14 participants | 36 participants |
| number of previous cesarean sections one | 8 participants | 8 participants | 16 participants |
| number of previous cesarean sections three | 0 participants | 1 participants | 1 participants |
| number of previous cesarean sections two | 0 participants | 7 participants | 7 participants |
| parity para 0 | 20 participants | 13 participants | 33 participants |
| parity para 1 | 10 participants | 7 participants | 17 participants |
| parity para 2 | 0 participants | 8 participants | 8 participants |
| parity para 3 | 0 participants | 2 participants | 2 participants |
| previous ectopic pregnancies no ectopic | 29 participants | 28 participants | 57 participants |
| previous ectopic pregnancies previous ectopic | 1 participants | 2 participants | 3 participants |
| previous vaginal deliveries no vaginal deliveries | 28 participants | 26 participants | 54 participants |
| previous vaginal deliveries previous vaginal deliveries | 2 participants | 4 participants | 6 participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| weight | 66.36 kilograms STANDARD_DEVIATION 6.04 | 76.31 kilograms STANDARD_DEVIATION 8.35 | 71.34 kilograms STANDARD_DEVIATION 8.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Serum Nesfatin 1
Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients during the laparoscopy procedure immediately after initial evaluation and before any intervention.The blood samples were centrifuged immediately after their collection at 5000 rpm for 10 min and serum samples were stored at -20 °C until analysis. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay ELISA technique using commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits, Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals.
Time frame: 24 hours
Population: In the endometriosis group, two patients were stage I, one was stage II, 12 were stage III and 15 were stage IV according to the revised ASRM scoring system. In the control group, 13 had polycystic varies, 11 had variable pelvic peritoneal adhesions, 4 had tubal block , one had unilateral ovarian cyst and one patient had atrophic ovaries.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Endometriosis | Serum Nesfatin 1 | 190 picogram/millilitre |
| Control | Serum Nesfatin 1 | 510 picogram/millilitre |
Comparison: Normality of numerical data distribution was examined by the Shapiro-Wilk. Normally distributed numerical variables were presented as mean±SD and inter-group differences were compared using unpaired t test. Skewed numerical variables were presented as median and interquartile range and between-group differences were compared using Mann-Whitney U test. Ordinal data were compared using the chi-squared test for trend. Correlations among numerical variables were tested by Spearman rank correlation.p-value: 0.05Wilcoxon (Mann-Whitney)