Revisiting Omental Transposition in Locally Advance and Locally Recurrent Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Survival Rate
• Intervention / Treatment: Procedure: Omental transposition

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Queen Sirikit Centre for Breast Cancer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• The patients with refusal

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Curative group; Locally advance breast cancer and locally recurrent breast cancer without metastasis underwent omental transposition	Procedure: Omental transposition; Harvesting the omentum to cover irradiated defects of breast cancer; Other Names: Omental graft
Palliative group; Locally advance breast cancer and locally recurrent breast cancer with metastasis underwent omental transposition	Procedure: Omental transposition; Harvesting the omentum to cover irradiated defects of breast cancer; Other Names: Omental graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival time	22 years

Collaborators and Investigators

• Sponsor: Queen Sirikit Centre for Breast Cancer

Study record dates

Study Major Dates

• Study Start: January 1, 1994
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 5, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): February 14, 2017
• Last Update Submitted That Met QC Criteria: February 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 635/59

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No