Effect of Intraperitoneal Insulin Administration After Laparoscopy in Insulin-Resistant Patients on Prevention of Postoperative Adhesion Recurrence: A Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Prevention of Postoperative Adhesions
• Interventions: Drug: Actrapid insulin; Drug: Normal saline

• Registration Number: NCT07007130
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-27
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study Start: 2025-06-01
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Actrapid insulin	-
Control group	Normal saline	-

Primary Outcome Measures

Name	Time	Method
Adhesion scoring at second-look laparoscopy	4-6 weeks postoperatively	Adhesion scoring at second-look laparoscopy (4-6 weeks postoperative)

Secondary Outcome Measures

Name	Time	Method
Postoperative pain scores	Immediately after operation
Hypoglycemic events	4 hours after the operation
Fertility rates	At 6 months