ICE Study

Duration of Study:

24 months. 

Number of participants:

 70

Participating centres:

• University Hospital of North Midlands, Stoke on Trent, United Kingdom 

• Birmingham Women’s and Children NHS Foundation Trust, Birmingham, United Kingdom.
  

  Funded by:

National Institute for Health Research, (Research for Patient benefit)

Chief Investigator:

• Mr. Gourab Misra, FRCOG, Diploma in Advanced Gynecological Endoscopy, MCH Robotic Surgery, (Consultant Gynecologist University Hospital of North Midlands)

• Professor Thomas Justin Clark, FRCOG, MD (Hons), DFFP, Consultant Gynecologist at Birmingham Women’s and Children NHS Foundation Trust.

If you are eligible, would like to take part and your local hospital is a study site, they will send you information about the ICE study.

To take part you will be asked to sign a consent form and asked some questions about your health and your endometriosis symptoms. After this you will be randomised to receive:

Group 1 (traditional technique stents):

A small stent (soft tube) will be temporarily placed in each ureter to identify and protect it during surgery. The stents are either removed at the end of the operation or may be left in for4-6 weeks.

Group 2 (new technique dye):

The dye will be injected through a ureteric catheter into each ureter. This dye allows surgeons to see the ureters under a special light.

Whichever group you are in, you will continue to receive NHS care. We will follow you up in the study for 12 weeks using by sending questionnaires for you to complete at home.

There is an extra part of the study that is optional. In this extra part, we will ask some participants to take part in a focus group.

If you agree to take part in the ICE study, we will ask you whether or not you would like to receive information about these focus groups and to be contacted by the facilitators.

You can find out more information about ICE here. (insert links)

Endometriosis is a common non-cancerous condition where tissue similar to the womb lining is found growing elsewhere, most commonly inside the pelvis. Symptoms vary but can include intense pelvic pain and infertility.

Symptoms of endometriosis

Endometriosis is often found in areas around the womb, such as the ovaries, fallopian tubes and lining of the pelvis.

It also sometimes affects organs, such as the bladder and bowel. Rarely, endometriosis is found in areas outside the pelvis, such as in the chest.

Symptoms happen when patches of endometriosis break down and bleed during your period but cannot leave your body.

You might have some symptoms during your period, such as:

• severe period pain, that stops you from doing your normal activities
• heavy periods, where you need to change your pads or tampons every 1 to 2 hours, or you may bleed through to your clothes.
  pain when you poo or pee

You can have other symptoms at any time in your menstrual cycle, such as:

• pain in your lower tummy and back (pelvic area)
• pain during or after sex
• extreme tiredness (fatigue)
• pain or bleeding in other areas, such as in the chest, which may cause shortness of breath and coughing up blood
• You may also have difficulty getting pregnant and have low mood or anxiety.

Endometriosis is commonly diagnosed in women and girls, from when their periods start (puberty) through to menopause. It can affect anyone who has periods.

We need women aged 18-50 years old undergoing minimal access surgery (Laparoscopic or Robotic Assisted) for deep endometriosis.

If you decide to participate, we will confirm that you are scheduled for endometriosis surgery and that you fit the target population.

You will have the opportunity to discuss the study with the research team, ask questions, and give written informed consent.

• University Hospital of North Midlands

• Birmingham Women and Children’s NHS