Prevention of Postoperative Adhesions
Conditions
Brief summary
Adhesion formation following laparoscopic pelvic surgery remains a significant cause of chronic pelvic pain, infertility, and surgical complications. Patients with insulin resistance (IR) may have heightened inflammatory responses and impaired tissue healing, contributing to a higher risk of adhesion formation. Intraperitoneal administration of insulin has shown promising results in animal models by modulating inflammatory mediators and enhancing fibrinolysis. This trial aims to evaluate the efficacy and safety of intraperitoneal insulin instillation at the end of laparoscopy in women with insulin resistance.
Detailed description
This is a prospective, randomized, controlled, double-blind clinical trial designed to evaluate the efficacy of intraperitoneal insulin administration at the end of laparoscopic surgery in women with insulin resistance, aiming to reduce postoperative adhesion formation. The study will be conducted at a dr saed hospital and will enroll 100 female patients diagnosed with insulin resistance undergoing laparoscopy for infertility or chronic pelvic pain.
Interventions
DRUGActrapid insulin
0.1 IU/kg of short-acting human insulin diluted in 100 mL of normal saline, instilled intraperitoneally before closure
DRUGNormal saline
100 mL normal saline intraperitoneally
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-40 years * Diagnosed insulin resistance (e.g., HOMA-IR \>2.5 or fasting insulin \>15 uIU/mL) * Indicated for laparoscopy for infertility or pelvic pain * BMI 20-35 kg/m² * Able and willing to give informed consent
Exclusion criteria
* Diabetes mellitus requiring pharmacologic treatment * History of peritonitis or major abdominal surgery in the past 6 months * Known allergy or sensitivity to insulin * Chronic steroid or immunosuppressive use * Pregnancy or lactation * Participation in another clinical trial within the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adhesion scoring at second-look laparoscopy | 4-6 weeks postoperatively | Adhesion scoring at second-look laparoscopy (4-6 weeks postoperative) |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative pain scores | Immediately after operation |
| Hypoglycemic events | 2 hours after the operation |
| Fertility rates | At 6 months |
Outcome results
None listed