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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prevention of Postoperative Adhesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

Group Type ACTIVE_COMPARATOR

Actrapid insulin

Intervention Type DRUG

0.1 IU/kg of short-acting human insulin diluted in 100 mL of normal saline, instilled intraperitoneally before closure

Control group

Group Type SHAM_COMPARATOR

Normal saline

Intervention Type DRUG

100 mL normal saline intraperitoneally

Interventions

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Actrapid insulin

0.1 IU/kg of short-acting human insulin diluted in 100 mL of normal saline, instilled intraperitoneally before closure

Intervention Type DRUG

Normal saline

100 mL normal saline intraperitoneally

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No