Revisiting Omental Transposition in Locally Advance and Locally Recurrent Breast Cancer

NCT03052621 | Completed DMC

• 1 other identifier: 635/59
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Locally advance breast cancer and extensive locoregional recurrence are still considered as complexity of reconstruction. Although previous studies concluded that omental transposition was considerably indicated in poor vascularity in irradiated tissue, secondary infection and large defect become the obstacles of local tissue flaps. While some centres showed the excellent healing of omental transposition. Meanwhile, many studies showed the preferable outcome in escalating radiotherapy in term of locoregional control. In the investigators' institute, omental transposition in breast cancer has been developed for twenty years. The only institute in Thailand enhanced using this procedure in order to closure of large primary breast cancer and chest wall recurrence. This procedure is undertaken by single surgeon (Dr. K.J.). The investigators' protocol of omental transposition is including preoperative chemotherapy, preoperative accelerated radiation up to 80 Gy, approval of breast cancer centre committee, and meticulous wound care including vacuum assisted wound dressing, non-adhesive dressing. As a result, survival time could be improved.

Conditions

Survival Rate

Outcome Measures

Primary Outcomes (1)

• Survival time

  22 years

Study Arms (2)

Curative group

Locally advance breast cancer and locally recurrent breast cancer without metastasis underwent omental transposition

Procedure: Omental transposition

Palliative group

Locally advance breast cancer and locally recurrent breast cancer with metastasis underwent omental transposition

Procedure: Omental transposition

Interventions

Omental transposition PROCEDURE

Harvesting the omentum to cover irradiated defects of breast cancer

Also known as: Omental graft

Curative group; Palliative group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients with locally advance or locally recurrent breast cancer that aggressive chemoradiation needed.

You may qualify if:

• The patients with omental transposition operation within King Chulalongkorn Memorial Hospital
• More than 18 years of age

You may not qualify if:

• The patients with refusal

Sponsors & Collaborators

• Queen Sirikit Centre for Breast Cancer: lead

Study Sites (1)

Queen Sirikit Centre for Breast Cancer

Bangkok, Bangkok, 10330, Thailand

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: February 14, 2017
• Study Start: January 1, 1994
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

TH (1)