RecruitingObservational

Reconstruction after advanced pelvic cancer surgery

If you have advanced cancer in your lower belly area (pelvis), you might need big surgery to remove it. This surgery can leave a gap. Doctors often use tissues from other parts of your body or special animal-based patches to fill this gap, a process called reconstruction. This study wants to understand how these different reconstruction methods affect patients over 12 months after surgery. Researchers will look at how your daily life changes, if you have complications, and the costs involved. The goal is to help patients and doctors make better decisions together about which reconstruction method might be best, leading to fewer regrets and better long-term health.

At a glance

Status

Recruiting

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

236

Start

17 May 2022

Estimated completion

01 Dec 2026

Advanced pelvic cancers

What is this study about?

This study is looking into a really important topic for people who have major surgery for advanced cancers in their lower stomach area (pelvis). These cancers can affect organs like the bowel, bladder, or reproductive organs. Sometimes, the cancer spreads deeply, and to give you the best chance of getting well, doctors might need to perform a very big operation called Extended Margin Cancer Surgery (EMCS). This surgery removes not just the cancer but also some surrounding parts, which can leave a large empty space in the pelvis.

Leaving this space empty can cause problems like fluid build-up, infections, and wounds that don't heal well. This is sometimes called 'empty pelvis syndrome' and it can make recovery difficult and affect your quality of life. To help prevent these issues, surgeons often use special techniques to fill that empty space. They might use tissue flaps (which are pieces of muscle and skin taken from another part of your body) or special animal-derived meshes (like a soft patch) to reconstruct the area.

While these reconstruction methods are used, doctors don't fully understand how each type affects a patient's quality of life, how many complications they might have, or the financial costs involved in the long run. This study aims to gather this missing information. It will follow patients for 12 months after surgery to see how different reconstruction methods impact their lives, health, and finances. The findings will help doctors and patients make more informed choices about the best way to manage recovery after this challenging surgery.

Key takeaways

Study examines different ways to rebuild the body after major pelvic cancer surgery.
Aims to understand impact on quality of life, complications, and costs.
Compares using tissue flaps versus medical meshes for reconstruction.
Involves completing questionnaires over 12 months after surgery.
No new treatments or procedures are part of the study.
Findings will help patients and doctors make better decisions in the future.

Who may be eligible?

This study is looking for adults aged 18 or older who have advanced cancer in their pelvis. This includes cancers of the bowel, anus, womb, ovaries, cervix, bladder, prostate, or other rare cancers called sarcomas. You would be considered if you are having major surgery to remove the cancer, and your doctors plan to rebuild the area using either a tissue flap or a special mesh.

You cannot take part if your doctors don't think surgery will help cure your cancer, or if you are only having a smaller type of surgery that doesn't include significant reconstruction of the pelvic floor. Also, if your reconstruction only involves sewing the skin together, or if you are unable or unwilling to give your consent (permission) to join the study, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced cancer in your pelvis (e.g., bowel, bladder, reproductive organs)?
Are you having major surgery that removes cancer and requires reconstruction of the pelvic floor?
Will your reconstruction involve a tissue flap or a special mesh?
Are you able and willing to give your informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be one of 236 patients from 10 different NHS hospitals. You won't need to take any new medicines or have extra tests just for the study. Instead, the study will gather information about the care you're already receiving.

The main part of your involvement will be filling out questionnaires about your quality of life at different times: when you first join the study, and then again 3, 6, and 12 months after your surgery. Researchers will also look at your existing health records to understand things like complications, how long you stay well, and if the cancer comes back. They will also look at healthcare costs. Some patients will also be invited for an interview to share their experiences in more depth.

Potential risks and benefits

There are no identified risks for participating in this specific study, as it mainly involves filling out questionnaires and looking at your existing medical information. You won't be having any extra procedures. The main benefit of taking part is that your experiences will help doctors and future patients make better decisions about rebuilding the body after major pelvic cancer surgery. This information is currently missing. You are always free to change your mind and withdraw from the study at any time without affecting your medical care.

Locations (17)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Southampton NHS Foundation Trust
City only
Southampton, United Kingdom
Salisbury NHS Foundation Trust
City only
Salisbury, United Kingdom
Dorset County Hospital NHS Foundation Trust (uhs)
City only
Dorchester, United Kingdom
Leeds Teaching Hospitals NHS Trust
City only
Leeds, United Kingdom
Mid Yorkshire Teaching NHS Trust
City only
Wakefield, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Unverified
Newcastle upon Tyne, United Kingdom
University Hospitals Dorset NHS Foundation Trust
Unverified
Poole, United Kingdom
Yeovil District Hospital NHS Foundation Trust
Unverified
Yeovil, United Kingdom
Swansea Bay University Local Health Board
Unverified
Neath, United Kingdom
Portsmouth Hospitals University National Health Service Trust
Unverified
Portsmouth, United Kingdom
Hampshire Hospitals NHS Foundation Trust
Unverified
Basingstoke, United Kingdom
Royal Devon University Healthcare NHS Foundation Trust
Unverified
Exeter, United Kingdom

Common questions

What kind of cancers are included in this study?

This study includes advanced cancers of the bowel (rectum, anus), bladder, prostate, and female reproductive organs (womb, ovaries, cervix), as well as certain rare cancers called sarcomas, all located in the pelvic area.

What does 'perineal reconstruction' mean?

It means surgery to rebuild the area between the legs after major cancer surgery. This is often done using your own tissue (a 'flap') or a special medical patch ('mesh') to fill the space left by the removed cancer and organs.

Do I need to take new medication for this study?

No, you do not need to take any new medication or have any extra procedures specifically for this study.

How long will I be involved in the study?

Your involvement will last for 12 months after your surgery, during which you will complete questionnaires at specific times.

Will my information be kept private?

Yes, all your personal and medical information will be handled confidentially and used according to strict privacy guidelines.

How to find out more

Malcolm West

malcolm.west@uhs.nhs.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.