FindTrial
Sign In

Use of medical device Bakri Balloon in surgery done to remove multiple organs in the pelvis.

Novel use of the Bakri balloon to minimize empty pelvis syndrome following total pelvic exenteration.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036913
Enrollment
30
Registered
2021-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C20- Malignant neoplasm of rectum

Interventions

Intervention1: Bakri balloon: Prosthetic device Bakri balloon will be inserted through a perineal incision into the empty pelvic cavity in a manner similar to the pelvic drain which is routinely used

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients undergoing total pelvic exenteration either minimally invasive or open in whom the Bakri balloon is placed will be included.

Exclusion criteria

Exclusion criteria: Patients who do not give consent for Bakri balloon placement.

Design outcomes

Primary

MeasureTime frame
Early and late Post operative complicationsTimepoint: 2 years—

Secondary

MeasureTime frame
30 day post operative mortality Timepoint: 2 years—

Countries

India

Contacts

Public ContactAvanish Saklani

Tata Memorial Hospital

asaklani@hotmail.com

Outcome results

None listed

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