| CTRI Number |
CTRI/2024/09/074415 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between ablation of superior hypogastric plexus and ablation of both superior hypogastric plexus and ganglion impar using radiofrequency method to reduce lower abdominal pain in women with endometriosis |
|
Scientific Title of Study
|
Comparative efficacy between fluoroscopy guided radiofrequency ablation of superior hypogastric plexus and radiofrequency ablation of both superior hypogastric plexus and ganglion impar in endometriosis related pelvic pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rhitushree Biswas |
| Designation |
Post Graduate Trainee (MD) |
| Affiliation |
Dept. of Physical Medicine and RehabilitationIPGMER, KOLKATA |
| Address |
53, A.C. Road; P.O.- Khagra, DIST-Murshidabad, Pin -742103
Dept. of Physical Medicine & Rehabilitation
IPGMER & SSKM Hospital
Bhowanipore
Kolkata 700020
Murshidabad
WEST BENGAL
742103
India |
| Phone |
7797357101 |
| Fax |
|
| Email |
biswasrhitushree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Pramanik |
| Designation |
Professor and Head Of the Department |
| Affiliation |
Institute Of Postgraduate Medical Education and Research |
| Address |
School Of Physical Medicine
Institute Of Post Graduate Medical Education & Research and SSKM Hospital
AJC Bose Road
Bhowanipore
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9432594882 |
| Fax |
|
| Email |
rpramanik2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Pramanik |
| Designation |
Professor and Head Of the Department |
| Affiliation |
Institute Of Postgraduate Medical Education and Research |
| Address |
SCHOOL OF PHYSICAL MEDICINE
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION & RESEARCH AND SSKM HOSPITAL
AJC BOSE ROAD
BHOWANIPORE
KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
9432594882 |
| Fax |
|
| Email |
rpramanik2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute Of Postgraduate Medical Education and Research,
SSKM Hospital |
|
|
Primary Sponsor
|
| Name |
Institue of Postgraduate Medical Education and Research, SSKM Hospital |
| Address |
AJC Bose Road
Bhowanipore
Kolkata
West Bengal-700020 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| RHITUSHREE BISWAS |
Institute Of Postgraduate Medical Education and Research, Kolkata |
School Of Physical Medicine, Institute Of Postgraduate Medicine Education and Research, SSKM Hospital, AJC Bose Road, Bhowanipore, Kolkata
Kolkata
WEST BENGAL |
7797357101
biswasrhitushree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fluoroscopy guided Radiofrequency Ablation of Superior Hypogastric Plexus |
These procedures will be done for pelvic pain in endometriosis, under C-Arm guidance, posterolateral approach with 145 cm 22 G Radiofrequency Cannula for Superior Hypogastric Plexus Radiofrequency lesioning was performed at 80 degree C after injecting 1 ml 2 % Lignocaine per site. Duration of the procedure will be average 30 min. |
| Comparator Agent |
Fluoroscopy guided Radiofrequency Ablation of Superior Hypogastric Plexus with Ganglion Impar |
These procedures will be done for pelvic pain in endometriosis, under C-Arm guidance, posterolateral approach with 145 cm 22 G Radiofrequency Cannula for Superior Hypogastric Plexus and trans-sacrococcygeal approach for Ganglion Impar with 100 cm 22G radiofrequency cannula. Radiofrequency lesioning was performed at 80 degree C after injecting 1 ml 2 % Lignocaine per site. Duration of the whole procedure will be average 45 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
i. Patient suffering from endometriosis diagnosed by Department of Obstetrics and Gynaecology with the help of imaging technique (e.g.- USG, MRI) &/or laparoscopic method &/or histology as supplement to clinical features.
ii. Age of patient: above 18 years
iii. Patient with moderate to severe pain (VAS≥4)
iv. Consent of the patient for the procedure
v. Pain not controlled by conservative method
|
|
| ExclusionCriteria |
| Details |
i. Abnormal coagulation profile
ii. Allergy or contraindications to the used medication
iii. Patients with local &/or systemic infections
iv. History of neurological or psychiatric disorder
v. Pregnancy
vi. Patients suffering from unstable cardiovascular or respiratory disorder
vii. Distorted local anatomy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VISUAL ANALOG SCALE |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="6"
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 - NO
|
Brief Summary
Modification(s)
|
PROPOSED TOPIC OF RESEARCH: COMPARATIVE EFFICACY BETWEEN FLUOROSCOPY GUIDED RADIOFREQUENCY ABLATION OF SUPERIOR HYPOGASTRIC PLEXUS & RADIOFREQUENCY ABLATION OF BOTH SUPERIOR HYPOGASTRIC PLEXUS AND GANGLION IMPAR IN ENDOMETRIOSIS RELATED PELVIC PAIN
OBJECTIVES OF PROPOSED RESEARCH: To observe separate efficacy of radiofrequency ablation (RFA) of Superior Hypogastric Plexus and RFA of Superior Hypogastric Plexus with Ganglion Impar and also compare between their efficacy in endometriosis related pelvic pain.
BACKGROUND OF PROPOSED RESEARCH: Endometriosis is one of the most common and debilitating diseases of women in reproductive age group. It constitute a great burden of different kinds of pelvic pain in women . There is significant impact of endometriosis, and particularly pain symptoms, not only on quality of life, but also on a range of activities and life domains including physical functioning, everyday activities and social life, education and work, sex, intimacy and intimate partnerships, and mental health and emotional well being. A significant number of patients, suffering from endometriosis associated pelvic pain are either non-responsive or inadequately responsive to available treatment modalities and research is ongoing to find new therapeutic options for this disease. For these patients, radiofrequency ablation of nerve plexuses carrying pain sensation from those viscera may be an effective alternative. There is scarcity of literatures on efficacy of RFA of superior hypogastric plexus as well as superior hypogastric plexus with ganglion impar in endometriotic pelvic pain reduction. So, our humble approach in this study is not only to assess the efficacy of these two procedures separately, but also compare between their efficacy in endometriotic pain reduction.
RESEARCH HYPOTHESIS: Significant reduction of pain in terms of VAS score in Endometriosis related pain following RFA of both Superior Hypogastric Plexus as well as Superior Hypogastric Plexus with Ganglion Impar. There will be significant difference of VAS score between these two procedures and combined approach will be more efficacious to reduce pain significantly.
METHODOLOGY: STUDY DESIGN- Parallel group, open label, randomised controlled trial STUDY DURATION- 18 months PLACE OF STUDY- Department of Physical Medicine & Rehabilitation, IPGME&R and SSKM Hospital STUDY POPULATION- Patients attending OPDs and admitted in IPDs of Department of Obstetrics & Gynaecology and Department of Physical Medicine and Rehabilitation. SAMPLE SIZE- TOTAL 38 (19 in each group) |