Prevention of Postoperative AdhesionsNCT07007130
Effect of Intraperitoneal Insulin Administration After Laparoscopy in Insulin-Resistant Patients on Prevention of Postoperative Adhesion Recurrence: A Randomized Controlled Trial
A study testing Actrapid insulin and Normal saline in people with Prevention of Postoperative Adhesions, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Prevention of Postoperative Adhesions
- What is being tested?
- Actrapid insulin and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Prevention of Postoperative Adhesions
- Being tested
- Actrapid insulin, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actrapid insulinDrug
0.1 IU/kg of short-acting human insulin diluted in 100 mL of normal saline, instilled intraperitoneally before closure
Normal salineDrug
100 mL normal saline intraperitoneally
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Not described Receives: Drug: Actrapid insulin |
| Control group | Sham comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion scoring at second-look laparoscopy
Adhesion scoring at second-look laparoscopy (4-6 weeks postoperative)
Measured: 4-6 weeks postoperatively
Secondary outcomes (4)
Postoperative pain scores
Measured: Immediately after operation
Hypoglycemic events
Measured: 2 hours after the operation
Hypoglycemic events
Measured: 4 hours after the operation
Fertility rates
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Postoperative AdhesionsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007130
- Sponsor's protocol ID
- Dr Sayed Elakhras study
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraperitoneal Insulin Administration After Laparoscopy in Insulin-Resistant Patients on Prevention of Postoperative Adhesion Recurrence: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07007130
- Acronym / sponsor ID
- Dr Sayed Elakhras study
- Conditions
- Prevention of Postoperative Adhesions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: Actrapid insulin |
| Control group | Sham comparator | Drug: Normal saline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Actrapid insulin0.1 IU/kg of short-acting human insulin diluted in 100 mL of normal saline, instilled intraperitoneally before closure | Drug | Intervention group |
| Normal saline100 mL normal saline intraperitoneally | Drug | Control group |
Primary outcome
Adhesion scoring at second-look laparoscopy
Time frame: 4-6 weeks postoperatively
Adhesion scoring at second-look laparoscopy (4-6 weeks postoperative)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Actrapid insulin and Normal saline in people with Prevention of Postoperative Adhesions, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion scoring at second-look laparoscopy (time frame: 4-6 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.