| CTRI Number |
CTRI/2024/12/078395 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of outcomes between two types of omentum removal during surgery in ovarian cancer patients |
|
Scientific Title of Study
|
Perioperative Outcomes in Total infragastric Omentectomy with or without Perigastric Arcade Resection in advanced epithelial OVarian cancer: A non-inferiority randomized-controlled-trial(POTOPAR-OV) |
| Trial Acronym |
POTOPAR-OV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjunath Shantaram Nayak |
| Designation |
Senior resident, Surgical Oncology |
| Affiliation |
All India Institute Of Medical Sciences Jodhpur |
| Address |
Room no 509,5th floor ,A block ,Department of surgical Oncology,AIIMS Jodhpur,Basni ,Phase 2 ,Industrial area
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9483759462 |
| Fax |
|
| Email |
manju.nayak1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeewan Ram Vishnoi |
| Designation |
Additional professor and Head, Department of Surgical Oncology |
| Affiliation |
All India Institute Of Medical Sciences- Jodhpur |
| Address |
Room no 509,5th floor ,A block ,Department of surgical Oncology,AIIMS Jodhpur,Basni ,Phase 2 ,Industrial area
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9455061569 |
| Fax |
|
| Email |
drjvishnoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeewan Ram Vishnoi |
| Designation |
Additional professor and Head, Department of Surgical Oncology |
| Affiliation |
All India Institute Of Medical Sciences- Jodhpur |
| Address |
Room no 509,5th floor ,A block ,Department of surgical Oncology,AIIMS Jodhpur,Basni ,Phase 2 ,Industrial area
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9455061569 |
| Fax |
|
| Email |
drjvishnoi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of medical sciences(AIIMS) Jodhpur,Basni ,Phase 2 ,Industrial area, Jodhpur, Rajasthan, India-342005 |
|
|
Primary Sponsor
|
| Name |
Manjunath Shantaram Nayak |
| Address |
Room no 509,5th floor ,A block ,Department of surgical Oncology,AIIMS Jodhpur,Basni ,Phase 2 ,Industrial area, Jodhpur, Rajasthan, India-342005 |
| 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 |
| Manjunath Shantaram Nayak |
All India Institute of Medical sciences(AIIMS Jodhpur) |
Room no. 509, 5th floor, A block, department of Surgical Oncology, OPD building, AIIMS Jodhpur, Basni(Phase-II) industrial area
Jodhpur
RAJASTHAN |
9483759462
manju.nayak1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(clinical trial), All India Institute Of Medical Sciences Jodhpur Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1 (Omentectomy with perigastric arcade exclusion) |
Patients in control arm are in whom total infragastric omentectomy done excluding the perigastric arcade which is being routinely done during omentectomy. |
| Intervention |
Group 2 (Omentectomy including perigastric arcade) |
Patients in intervention arm are in whom total infragastric omentectomy done including the perigastric arcade after ligating right and left gastroepiploic vessels. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Stage III or IV epithelial ovarian cancer patients undergoing primary cytoreductive or interval cytoreductive surgery |
|
| ExclusionCriteria |
| Details |
Gross disease present in perigastric arcade part of omentum during intraoperative assessment.
Previous gastric surgery
Recurrent ovarian cancer |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare perioperative complication rates between total infragastric
omentectomy with or without perigastric arcade resection during cytoreductive
surgery in advanced epithelial ovarian cancer |
one week post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the rate of microscopic involvement of the perigastric arcade of the omentum in patients undergoing total infragastric omentectomy with perigastric arcade resection & their predictive factors. |
Two weeks post surgery |
| To compare other perioperative outcomes between two arms including intraoperative blood loss, operative time, intensive care unit (ICU) admission rates & length of hospital stay (days). |
one week post surgery |
| To compare patients quality of life after 30 days of surgery among the perigastric arcade removal and perigastric arcade preserving groups based on EORTC QLQ-OV28 questionnaire. |
1 month post surgery |
| To compare the disease-free survival in both perigastric arcade removal and perigastric arcade preserving groups after 6 months of surgery. |
six months post surgery |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
30/12/2024 |
| 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="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [manju.nayak1234@gmail.com].
- For how long will this data be available start date provided 01-03-2027 and end date provided 01-03-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Despite the omentum being an established site for epithelial ovarian cancer metastases, the extent of its removal has not yet been adequately addressed. Removal of the perigastric arcade (PGA) of the omentum is one of the controversial aspects of omentectomy given its proximity to the stomach and thus the fear of injury, vascular compromise, and gastroparesis. There are no specific guidelines regarding the level of omentectomy, and therefore, in an attempt to fill the existing gaps in recent evidence, we are conducting the current study to assess the distribution of microscopic disease in the PGA (including the left and right gastro-epiploic vessels) in patients with epithelial ovarian cancer without macroscopic involvement of PGA and to compare intraoperative and immediate postoperative complications and the course of recovery in patients in whom the PGA was resected and those in whom the arcade was preserved during omentectomy. |