Surgery for cervix cancer follow up questionnaire

  • Research type

    Research Study

  • Full title

    Surgery for cervix cancer follow up questionnaire

  • IRAS ID

    190098

  • Contact name

    Arjun Jeyarajah

  • Contact email

    Arjun.Jeyarajah@bartshealth.nhs.uk

  • Sponsor organisation

    Barts Health NHS trust

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    Some women with early cervical cancer have a choice between a Trachelectomy or radical Hysterectomy. The oncological outcomes are comparable with 4% recurrence rates. However there is limited long term morbidity data including bladder dysfunction, lymphoedema, quality of life, problems with cervical suture, rates of premature menopause for Trachelectomy operations.

    Trachelectomy involves removing the cervix, surrounding tissue and pelvic lymph nodes on both sides. A stitch in the cervix is inserted and the isthmus of the Uterus is sutured to the vagina, preserving the Uterus enabling a pregnancy in the future.

    Fertility rates of 70% and pre-term delivery rate of 17% at <32 weeks have been shown. However follow up is usually <5 years and therefore may not be representative.

    St. Bartholomews hospital was the first hospital in the UK to perform a Trachelectomy operation in 1994. As a result we have looked after a large group of women over a long period of time. Other Cancer centres have only performed Trachelectomy operations within last few years.

    Obtaining recurrence rates and long term morbidity data will help in the pre-operative counselling of these women and enable patients with problems to be identified (if not already done so), so they get the right treatment.

    We are proposing a questionnaire study to collect recurrence rates, pregnancy outcomes, and long term morbidity data in patients following a Trachelectomy and recurrence rates and long term morbidity data in patients following a radical hysterectomy. All patients operated on 1/1/1994-01/02/2016 fulfilling inclusion and not exclusion criteria will receive an invitation letter, patient information sheet, questionnaire (specific for op) consent form and stamped addressed envelope in the post or in clinic. This will not cost them anything and will take 15 minutes to complete. We may also telephone them if necessary. The participants will not need to do anything else.

  • REC name

    London - London Bridge Research Ethics Committee

  • REC reference

    16/LO/1510

  • Date of REC Opinion

    30 Nov 2016

  • REC opinion

    Further Information Favourable Opinion