| CTRI Number |
CTRI/2024/08/071877 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
International Research on Advanced Surgery for Serious Rectal Cancer Cases |
|
Scientific Title of Study
|
Robotic multi-visceral resection for locally-advanced rectal
cancer – an international multicenter study. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avanish Saklani |
| Designation |
Professor & Colorectal Surgeon |
| Affiliation |
Tata memorial hospital dr ernest Borges marg parel Mumbai |
| Address |
Department of Surgical Oncology tata memorial hospital dr ernest Borges marg parel Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7400319886 |
| Fax |
|
| Email |
asaklani@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avanish Saklani |
| Designation |
Professor & Colorectal Surgeon |
| Affiliation |
Tata memorial hospital dr ernest Borges marg parel Mumbai |
| Address |
Department of Surgical Oncology tata memorial hospital dr ernest Borges marg parel Mumbai
MAHARASHTRA
400012
India |
| Phone |
7400319886 |
| Fax |
|
| Email |
asaklani@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avanish Saklani |
| Designation |
Professor & Colorectal Surgeon |
| Affiliation |
Tata memorial hospital dr ernest Borges marg parel Mumbai |
| Address |
Department of Surgical Oncology tata memorial hospital dr ernest Borges marg parel Mumbai
MAHARASHTRA
400012
India |
| Phone |
7400319886 |
| Fax |
|
| Email |
asaklani@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Portsmouth Hospitals NHS Trust (PHT) |
| Address |
Queen Alexandra Hospital
Southwick Hill Road, Cosham, PO6 3LY |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Australia
France
India
Turkey
United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Avanish Saklani |
Tata Memorial Hospital |
Professor and Chief, Division of Colorectal services, Department of surgical oncology,Homi Bhabha Building 12th floor,Room No.1212,Tata Memorial Hospital,Dr.ernest borges street parel,Mumbai and ACTREC Kharghar Navi Mumbai Ext.7176
Mumbai
MAHARASHTRA |
7400319886
91-22-24146937
asaklani@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata memorial centre Institutional Ethics Committee III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K628||Other specified diseases of anus and rectum, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Age 18 years or above
2)Diagnosed with rectal cancer, up to 15cm from the anorectal junction
3)Preoperative scans suggest a T4 rectal cancer with involvement of one or more of the following structures-Urinary Bladder, Colon, Uterus, Vagina, Prostate, Seminal vesicles, Small bowel, Ovary
4)Patient assessed as fit for surgery (ASA I-III)
5)Elective surgery |
|
| ExclusionCriteria |
| Details |
1)Patients having signs of metastatic disease
2)Emergency resections
3)Palliative procedures
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess oncological safety and feasibility assessed by CRM involvement and conversion to open surgery |
Baseline assesment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary end points included duration of operation, amount of blood loss, length of hospital stay, & postoperative complications |
30 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="31"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Cancers
originating within 15 cm of the anal verge are defined as rectal cancers. They
are quite common cancers in the western world and comprise about one quarter of
all the colorectal cancers. The mainstay of treatment of these
cancers is surgery either with or without neoadjuvant therapy (chemo- or
radiotherapy). The surgical techniques have evolved over time in order to
improve outcomes. There was a time when abdominoperineal excision of rectum was
considered gold standard for low rectal cancers. Leaving everyone
with a permanent colostomy and, despites having had treatment, with poor
survival rates. Since the introduction of the TME surgery (Total Mesorectal
Excision) by Heald et al. in 1982, the oncological outcome of rectal cancer
patients has improved significantly. Improvement of the surgical technique in
combination with the advent of modern instruments facilitated sphincter saving
low and ultra-low anterior resections. During the same time as the introduction
of the TME surgery,in the late 80’s, minimal invasivelaparoscopic colorectal
surgery started and lead to significant improvements in the short term
postoperative outcomes. Since 1992 the laparoscopic approach was
applied to rectal cancer with promising results.However,
there was criticism on the laparoscopic approach, based on a long learning
curve, high conversion rates, lack of flexibility of the instruments and limited
hand eye coordination with lack of tactile perception. In order
to overcome these limitations, more recently, other minimal invasive
techniques, such as robotic (assisted) surgery and the trans-anal approach
(TaTME)were introduced as an alternative to laparoscopic surgery for better
patient outcomes.The
debate whether robotic assisted surgery is superior to laparoscopic surgery is
anongoing debate without a clear answer at this moment in favour of either one
of the techniques.The lack of significant difference between
the two approaches might be caused by surgical trials being performed with
robotic surgeons still in the beginning of their learning curve.The
debate whether robotic assisted surgery is superior to laparoscopic surgery is
anongoing debate without a clear answer at this moment in favour of either one
of the techniques.The lack of significant difference between
the two approaches might be caused by surgical trials being performed with
robotic surgeons still in the beginning of their learning curve. |