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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03052621
Other study ID # 635/59
Secondary ID
Status Completed
Phase N/A
First received January 5, 2017
Last updated February 13, 2017
Start date January 1994
Est. completion date December 2016

Study information

Verified date February 2017
Source Queen Sirikit Centre for Breast Cancer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Omental transposition
Harvesting the omentum to cover irradiated defects of breast cancer

Locations

Country Name City State
Thailand Queen Sirikit Centre for Breast Cancer Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Queen Sirikit Centre for Breast Cancer

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival time 22 years
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