Clinical trial · Observational
Reconstruction in Extended MArgin Cancer Surgery
REMACS - Understanding the Impact of Perineal Reconstruction After Extended MArgin Cancer Surgery on Longer-term Quality of Life, Morbidity and Health Economic Outcomes - a Prospective Longitudinal Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Advanced pelvic cancers are uncommon, with treatment being challenging. Around 4000 patients every year need treatment in the UK. Cancers can involve multiple organs and often need radiotherapy and chemotherapy before surgery. Surgery usually requires removal of multiple pelvic organs, including muscles, bone, and skin around the anus (the perineum). This can lead to complications relating to both the empty pelvis syndrome and closure of the perineal defect. Reconstruction is challenging, with frequently occurring complications, reducing speed of recovery and quality of life. This study investigates complication frequency, quality of life and expenses following different reconstruction techniques. The investigators hope to improve patient and doctor decision-making in this area and find the best methods of reconstruction to improve outcomes. REMACS has three work packages: 1. Maintenance of a database of patients undergoing colorectal surgery at Southampton and Salisbury Hospitals, including those undergoing extra-levator abdominoperineal excision and pelvic exenteration. This includes all routinely collected clinical data, imaging, health resource use, and patient reported outcome measures. 2. A collaborative national prospective cohort study investigating morbidity, health resource use, longitudinal quality of life outcomes (EORTC QLQ-C30 and disease-specific modules) and quality adjusted life years. The investigators will also assess financial toxicity using the comprehensive score for financial toxicity. 3. A qualitative study using semi-structured interviews to undertake a more complex evaluation of quality of life and patient experiences in patients that have recovered from their surgeries. The last two work packages have now been funded by an NIHR Research for Patient Benefit Grant
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Cancer | Malignant Abdominal Neoplasm | ALIAS | 0.90 |
| Pelvic Cancer | Malignant Pelvic Neoplasm | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
| Surgery--Complications | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological mesh reconstruction | Procedure | — | UNRESOLVED |
| Myocutaneous flap reconstruction | Procedure | — | UNRESOLVED |
| Primary closure reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients undergoing abdominoperineal excision
- description
- Abdominoperineal excision alone consists of removing only the rectum and anus
- interventionNames
- Procedure: Biological mesh reconstruction
- Procedure: Myocutaneous flap reconstruction
- Procedure: Primary closure reconstruction
- label
- Patient undergoing infralevator pelvic exenteration
- description
- Anterior pelvic exenteration includes resection of the structures of the anterior pelvis, namely the bladder, urethra and inner reproductive organs. Posterior pelvic exenteration comprises resection of the structures of the posterior pelvic cavity with reproductive organs and rectum, with or without the anal canal. Lateral compartment excision describes the resection of pelvic sidewall structures, such as the iliac vessels, piriformis and obturator internus muscles, and ischium, along with sacrotuberous and sacrospinous ligaments. Total pelvic exenteration entails removal of the bladder, urethra, inner reproductive organs, rectum, and anus with their muscles and ligaments. An infralevator pelvic exenteration includes the removal of the anus with their muscles and ligaments.
- interventionNames
- Procedure: Biological mesh reconstruction
- Procedure: Myocutaneous flap reconstruction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female patients aged 18 or older * Patients that have undergone pelvic exenteration or abdominoperineal excision at participating sites, at any time, that have complete data (work package 1 - Colorectal Surgery Database) * Patients undergoing pelvic exenteration or abdominoperineal excision at participating sites (work package 2 - prospective study) * Patients that have already had pelvic exenteration or abdominoperineal resection that can speak English (work package 3 - mixed-methods study) Exclusion Criteria: * Patients eligible for, but that are unfit, decline or are not offered abdominoperineal excision or pelvic exenteration surgery * Patients that undergo surgery by an intersphincteric abdominoperineal resection approach * Patients that are unable to complete the questionnaire over the telephone or online with a researcher * Patients unable or unwilling to provide informed consent * Patients that are prisoners in the custody of HM Prison Service or who are offenders supervised by the probation service
References
Publications (0)
Data not yet available