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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator |
| |
| Control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actrapid insulin | Drug | 0.1 IU/kg of short-acting human insulin diluted in 100 mL of normal saline, instilled intraperitoneally before closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adhesion scoring at second-look laparoscopy | Adhesion scoring at second-look laparoscopy (4-6 weeks postoperative) | 4-6 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain scores | Immediately after operation | |
| Hypoglycemic events | 2 hours after the operation | |
| Hypoglycemic events |
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Inclusion Criteria:
Exclusion Criteria:
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| Normal saline | Drug | 100 mL normal saline intraperitoneally |
|
| 4 hours after the operation |
| Fertility rates | At 6 months |
| ID | Term |
|---|---|
| C000006 | insulin, neutral |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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