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

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 - GLUTVRAM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005796

Enrollment

Registered

2014-05-09

Start date

2014-06-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C20 C76.3

Interventions

Group 1: 30 patients will undergo a primary reconstruction of the pelvic floor and perineum following radical oncologic resection of the pelvic malignancy via unilateral or bilateral gluteus maximus m

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
1-Incidence of postoperative morbidity and complications in the form of: • DVT, pulmonary embolism • Bed sores • Nosocomial infection • Sepsis 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. 3-Assessment of the delay of a planned adjuvant therapy(chemo- or radiotherapy) because of local and/or general complications.	—

Measure

Time frame

1-Incidence of postoperative morbidity and complications in the form of: • DVT, pulmonary embolism • Bed sores • Nosocomial infection • Sepsis 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. 3-Assessment of the delay of a planned adjuvant therapy(chemo- or radiotherapy) because of local and/or general complications.

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Countries

Germany

Contacts

Public ContactAhmed Abdou

Universitätsklinik für Allgemein- und Viszeralchirurgie, Klinikum Oldenburg

ahmedabdou@gmx.de0441/403-77297

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026