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NCT Number: NCT06800534

Perineal and Abdominal Reconstruction: a Comparison of Reconstructive Methodologies

The different reconstructive methods (V-Y flap, lotus flap, gracilis muscle flap, TRAM flap) will be compared with the complications that occurred following the surgery, so as to define which reconstructive methods have led to fewer complications and in which categories of patients.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Marco Pignatti, MD

CONTACT

[email protected]

+390512143614

About this study

he study is of a non-interventional observational nature. It involves the collection of patient data in pseudonymous form from preoperative and postoperative assessments in accordance with daily clinical practice and normally performed for proper patient management.

The data recorded in the study are obtained from the medical records of patients who are normally accessed by the doctors of the operating unit during daily practice.

After having performed a meticulous collection of the basic data of the patients (gender, age, remote pathological history, recent pathological history, type of demolitive and reconstructive surgery performed), the different reconstructive methods (V-Y flap, lotus flap, gracilis muscle flap, TRAM flap) will be compared with the complications that occurred following the surgery, so as to define which reconstructive methods have led to fewer complications and in which categories of patients.

The complications are assessed through the retrospective analysis of the outpatient reports that are normally drawn up during the usual follow-up outpatient visits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing pelvic-perineal amputations for oncological disease or chronic inflammatory diseases whose surgical treatment required the collaboration of the plastic surgeon
  • Patients with complications in the abdominal or pelvic-perineal region of surgical relevance and requiring reconstruction (enteric fistulas, abdominal wall defects)
  • Age greater than or equal to 18 years
  • Acquisition of written informed consent

Exclusion criteria

  • Incomplete or missing data.

Treatment and study plan

Primary outcomes

  1. Technical Success

    Time frame: From the first patient enrolled to the 50th patient, an average of 2 years

    Technical success is assessed by the number of reinterventions after 1 year from the treatment and the number of major complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Pignatti, MD

CONTACT

[email protected]

+390512143614

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: PLAST-GEN-1

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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