A Review of Functional and Surgical Outcomes of Gynaecological Reconstruction in the Context of Pelvic Exenteration

Study Overview
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Brief Summary
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Patients with locally advanced pelvic malignancy undergo radical procedures, necessitate organ reconstruction. Little is known about the preferred methods of gynaecological organ reconstruction in the context of pelvic exenteration. This review aims to identify which methods are commonly used and what outcomes are associated with each technique in order to further guide future practice.

Detailed Description
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The mainstay of treatment for patients with locally advanced pelvic malignancy is radical surgical excision combined, with (neo)adjuvant chemoradiotherapy where appropriate. The primary objective is to obtain a negative resection margin (R0) in order to achieve long-term survival. Centralisation of care and refinements in surgical technique have enabled surgeons specializing in advanced pelvic oncology to embark upon more aggressive approaches to accomplishing an R0 resection. With improved oncological outcomes has come an increased focus on quality-of-life (QoL), functional sequelae and patient experience and survivorship. Adequate experience and proficiency with reconstructive techniques has become one of the key components for surgeons practicing in pelvic oncology. Reconstructive procedures should be undertaken with the goals of improving wound healing, reducing morbidity and restoring anatomic form and function. These factors are of utmost importance in the context of pelvic exenteration, where wound complications are prevalent as a result of a larger pelvic dead space and the potential for contamination. Adverse impact on sexual function following pelvic surgery is also common where the autonomic nerves are involved. This is further compounded by the need to resect part or all of the vulvovaginar complex as part of an extirpative procedure, with resultant declines in QoL and overall psychosexual wellbeing. A number of methods have been proposed for reconstruction of the pelvic floor and vulva/vagina in females, including skin grafting, skin flaps, fasciocutaneous and myocutaneous flaps, as well as the formation of a neovagina in specific circumstances. Thereis a paucity of data with regard to the optimal approach to gynaecological organ reconstruction, with the majority of the literature referring to single-centre, retrospective series. This review sought to assess the preferred methods for gynaecological reconstruction at an international level, the clinical and technical particulars leading to the choice of each method and the short-term outcomes associated with each technique.

Official Title
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PelvEx 7: A Review of Functional and Surgical Outcomes of Gynaecological Reconstruction in the Context of Pelvic Exenteration

Conditions
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Pelvic Cancer

Intervention / Treatment
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* Procedure: Gynaecological reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven locally advanced or recurrent pelvic cancer (all subtypes - Rectal, Urological, Gynae, Sarcome) Aged over 18 years Undergoing a multi-visceral extended pelvic resection and requiring gynaecological reconstruction at the time of index operation Time period: 1st July 2016 - 31st July 2021 Exclusion Criteria: Strong evidence of metastatic or peritoneal disease No histological evidence of gynaecological organ involvement Procedure not carried out with curative intent Insufficient patient follow-up (Minimum of 30 days)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neovaginal reconstruction<br>Neovaginal reconstruction post-vulvovaginal resection | Procedure: Gynaecological reconstruction<br>* Methods of vulvovaginal reconstruction, e.g. flap formation, neovagina formation<br>|
| Flap Reconstruction<br>Flap closure of perineal defect post-gynaecological organ resection | Procedure: Gynaecological reconstruction<br>* Methods of vulvovaginal reconstruction, e.g. flap formation, neovagina formation<br>|
| No reconstruction/Primary closure<br>Primary closure of defect post-multivisceral, gynaecological organ-involving, resection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Number of patients experiencing short-term (up to 30 days postoperatively) morbidity | July 2016 - July 2021 | 
| Gynaecological Reconstruction | Number of patients with each method of reconstruction | July 2016 - July 2021 | 
| Perineal wound complications | Number of patients with superficial wound infections, abscess, dehiscence by type of reconstruction | July 2016 - July 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyspareunia | Dyspareunia | July 2016 - July 2021 | 
| Return to intercourse | Return to intercourse | July 2016 - July 2021 | 
| Pelvic pain | Chronic pelvic pain by type of reconstruction | July 2016 - July 2021 | 
| Histological outcomes | Radicality of resection, e.g. R0, R1 or R2, and histological subtypes | July 2016 - July 2021 |