New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT04677075
Collaborator
(none)
30
1
3
9.9

Study Details

Study Description

Brief Summary

Mastectomy is a cornerstone operative procedure in breast cancer treatment leaving a raw area behind with possibility of failure of primary closure sometimes with unavailability of facilities of reconstruction. This opened the door for this research to find a formula to predict the need of reconstruction

Condition or Disease Intervention/Treatment Phase
  • Procedure: mastectomy

Detailed Description

Surgical intervention for breast cancer includes dealing with the primary tumour, added to it is the axillary dissection with variable options in both of them according to multiple factors. Mastectomy represents a part of several operations as radical and modified radical mastectomy, while in others it may be the whole operation as in palliative simple mastectomy. Moreover, re-excision of local recurrence is another form of surgical intervention.

At the step of mastectomy or re-excision of locally recurrent disease, the challenge of closure may arise, as simple primary closure may not be possible because of wide wound gap. In this situation, reconstruction is unavoidably needed and this situation represents one of two situations in which reconstruction is indicated.

As reconstruction sometimes needs certain expertise which may not be available momentarily and needs previous arrangement. Moreover sometimes mastectomy exceeds the previous expectation leaving a big gap beyond simple approximation, so the investigators developed a formula to assess the need of reconstructive coverage.

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
New Formula to Predict the Need for Reconstructive Coverage Following Mastectomy
Actual Study Start Date :
Aug 15, 2020
Actual Primary Completion Date :
Nov 15, 2020
Actual Study Completion Date :
Nov 15, 2020

Arms and Interventions

Arm Intervention/Treatment
mastectomy group

patients with breast cancer and eligible for mastectomy

Procedure: mastectomy
mastectomy either simple or modified radical

Outcome Measures

Primary Outcome Measures

  1. sternal length [for each patient at time of operation]

    the length of the sternum in cm

  2. Upper flap length [for each patient at time of operation]

    the perpendicular line from the highest point of the upper border of mastectomy ellipse to the clavicle in cm

  3. Lower flap length [for each patient at time of operation]

    the perpendicular line from the lowest point of the lower border of mastectomy ellipse to the 7th rib in cm

  4. flap index [through study completion, an average of 3 months]

    entangling of the above measurement in an equation to yield a number so when the distance from the clavicle to the 7th rib (in the midclavicular plane) is subtracted from it, a number is yielded, predicting the feasibility of closure without need to reconstruction

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients needs total mastectomy for management of their breast condition
Exclusion Criteria:
  • Patient with breast disease treated surgically by any intervention other than total mastectomy

  • Patients with skin disease affecting its stretchability

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine Zagazig Sharqia Egypt 44519

Sponsors and Collaborators

  • Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Joseph Rizk Awad, lecturer of surgery, Zagazig University
ClinicalTrials.gov Identifier:
NCT04677075
Other Study ID Numbers:
  • mastectomy coverage formula 20
First Posted:
Dec 21, 2020
Last Update Posted:
Dec 21, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Joseph Rizk Awad, lecturer of surgery, Zagazig University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2020