Gluteus maximus myocutaneous flap versus vertical rectus abdominis myocutaneous flap (VRAM) in primary reconstruction of pelvic floor defects following radical pelvic surgery,A randomised controlled monocentric Study

Not Applicable

Conditions: C20
C76.3
Malignant neoplasm of rectum
Pelvis

Registration Number: DRKS00005796

Lead Sponsor: niversitätsklinik für Allgemein- und Viszeralchirurgie, Klinikum Oldenburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

Inclusion Criteria

1-Patients suffering from primary or secondary pelvic malignancies e.g. colorectal,gynaecological and urological malignancies which indicate a radical pelvic procedure in the form of TPE or APE
2-Patients should be at least 18 years old and physically and mentally fit for consent.
3-A signed consent form accepting the participation of the study shpuld be provided

Exclusion Criteria

1-Contemporary psychiatric illness
2-Patients unwilling to consent
3-Patients participating in parallel contradicting studies.
4-Patients under immunosppressive therapy
5-Locoregional dystrophies or history of previous operations in the planned flap harvest area.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1•Length of hospital stay<br>2•Mortality rate amongst the patients of the two groups<br>3•Duration of woundhealing<br>4•Local complications, including: <br>a-Donor site morbidity<br>b-Delayed woudhealing<br>c-Rate of flap related compications e.g. dehiscence and flap necrosis (partial and/or total)<br>5•Incidence of abdominal and pelvic floor herniation<br>

Secondary Outcome Measures

Name	Time	Method
1-Incidence of postoperative morbidity and complications in the form of:<br>•DVT, pulmonary embolism<br>•Bed sores<br>•Nosocomial infection<br>•Sepsis<br>2-Assessment of the quality of life of the patients in both groups using the Short Form (36) at the 3rd and the 6th months postoperatively. <br>3-Assessment of the delay of a planned adjuvant therapy(chemo- or radiotherapy) because of local and/or general complications.<br>