Effect of Intraperitoneal Insulin Administration After Laparoscopy in Insulin-Resistant Patients on Prevention of Postoperative Adhesion Recurrence: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Actrapid insulin, Normal saline.
- Who it may be relevant to
- Registry conditions: Prevention of Postoperative Adhesions. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Actrapid insulin
0.1 IU/kg of short-acting human insulin diluted in 100 mL of normal saline, instilled intraperitoneally before closure - Drug Normal saline
100 mL normal saline intraperitoneally
Primary outcome measures
- Adhesion scoring at second-look laparoscopy [Time frame: 4-6 weeks postoperatively]
Secondary outcome measures (4)
- Postoperative pain scores [Time frame: Immediately after operation]
- Hypoglycemic events [Time frame: 2 hours after the operation]
- Hypoglycemic events [Time frame: 4 hours after the operation]
- Fertility rates [Time frame: At 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07007130 · Dr Sayed Elakhras study