| CTRI Number |
CTRI/2024/05/066983 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does stitching down of flap tissue affect the fluid build up under flap after surgery for breast cancer |
|
Scientific Title of Study
|
To study the effect of flap fixation on seroma formation in patients undergoing modified radical mastectomy a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amjad Sayeed |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of General Surgery, 5th Floor, Nehru Buidling,
Post Graduate Institute Of Medical Education and Reasearch, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9608976638 |
| Fax |
|
| Email |
amjadsayeed001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Professor Divya Dahiya |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of General Surgery, 5th floor, Nehru Buidling,
Post Graduate Institute Of Medical Education and Reasearch, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9501583520 |
| Fax |
|
| Email |
dahiyadivya30@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Professor Divya Dahiya |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of General Surgery, 5th floor, Nehru Buidling,
Post Graduate Institute Of Medical Education and Reasearch, Sector 12, Chandigarh
Chandigarh CHANDIGARH 160012 India |
| Phone |
9501583520 |
| Fax |
|
| Email |
dahiyadivya30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Dr Amjad Sayeed |
| Address |
Department of general surgery, 5th floor, Nehru Building
Post Graduate Institute Of Medical Education and Research, Sector 12, Chandigarh
PIN: 160012 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amjad Sayeed |
Postgraduate Institute of Medical Education and Researcgh, Chandigarh |
Dept of General Surgery, Block B, 5th floor, Nehru Hospital, POGIMER, Chandigarh Chandigarh CHANDIGARH |
09608976639
amjadsayeed001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Drain placement without flap fixation |
After modified radical mastectomy, the flaps will not be fixed. Only suction drain will be placed. |
| Intervention |
Fixation of mastectomy flap to pectoralis major followed by drain placement |
After Modified radical mastectomy, the skin flap will be fixed to pectoralis major with intermittent vicryl 3-0 sutures placed approximately 2.5cm apart
this will be followed by suction drain placement
Frequency: This intervention will be done only once at the time of surgery
Duration of intervention: The flap fixation process will take about 10 minutes. This will remain with the patient in the whole post operative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Biopsy proven breast cancer patients who are scheduled for Modified Radical Mastectomy
2. Female Aged 18-60 years
3. Acceptance of the study by the patient by a valid informed consent
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1. Patients who will undergo breast conservative surgery
2. Patients who will have sentinel node biopsy only
3. Patients who had breast reconstruction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the total duration of drain kept in patients undergoing modified radical mastectomy
|
at 4 weeks, 8 weeks and 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the total volume of drain output in patients undergoing modified radical mastectomy |
at 4 weeks, 8 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Breast cancer
is the most common cancer and is the leading cause of cancer related death
among women worldwide. According to the World Health Organization, the
estimated number of newly diagnosed breast cancer cases worldwide was 2,26,1419
in 2020.1 Breast cancer has ranked number one cancer among Indian
females with age adjusted rate as high as 25.8 per 100,000 women and mortality
12.7 per 100,000 women.2
Treatment
options include surgery, chemotherapy, immunotherapy, radiation therapy,
hormonal therapy, and targeted therapy. The most common type of breast surgery
is either modified radical mastectomy (MRM) or breast conservative surgery
(BCS) with axillary dissection. Mastectomy remains the common surgical
treatment. Seroma is the most common complication following breast cancer
surgery (15-85%)3 which is defined as accumulation of fluid in the
dead space. Seroma forms secondary to accumulation of lymphatic fluid due to
damage of lymphatic vessels after axillary dissection. Fluid collection usually
occurs between pectoralis muscle and skin flap. It can also cause pain,
discomfort, delays wound healing and increases the risk of infection which
further increases the hospital stay and delays the start of adjuvant treatment.
Exact
pathophysiology of seroma formation is not known. Several factors are held
responsible for seroma formation which includes the type of surgery and extent
of lymph node dissection. Type of surgical instrument used in the surgery also
affects the seroma formation as use of electrocautery increases the incidence
of seroma formation.4 However, various predictors have been
anticipated which may contribute to seroma formation like age, high body mass
index, breast volume, diabetes, hypertension, radiation, neoadjuvant
chemotherapy, lymph node involvement by the tumor and the number of lymph nodes
dissected during surgery.
To obliterate
the dead space after surgery various mechanical and chemical methods have also
been proposed which decreases the seroma formation subsequently. Ways to
prevent seroma formation includes 1) external compression, 2) flap fixation, 3)
use of tissue glues/ tranexamic acid 4) quilting or 5) use of closed suction
wound drainage.5 Drains keep the wound dry and help flaps to stick
to the chest wall. However, there are several disadvantages of prolonged
drainage such as continuous discomfort to the patient, accidental slippage of
drain, infection because of retrograde migration of bacteria, prolonged
hospitalization or frequent visits to the hospital.
Ideal wound
closure should minimize seroma formation by holding skin flaps firmly to the
chest wall and obliterating the dead space. However,
there is no optimal method but one of
the widely tested methods is flap fixation. In this, instead of directly
closing the flaps and leaving a cavity beneath it, the flaps are first sutured
to the underlying pectoralis major muscle to obliterate the dead space. There is a lack of consensus with different groups producing conflicting
results about the efficacy of this technique in reducing seroma formation.
Therefore, we aim
to study the effect of flap fixation on seroma formation in patients undergoing
modified radical mastectomy. |