| CTRI Number |
CTRI/2025/10/096274 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Surgical anatomy and its clinical Relevance |
|
Scientific Title of Study
|
Surgical anatomy of sciatic nerve and pudendal Nerve in deep gluteal space and its clinical Relevance |
| 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 Ranjana Verma |
| Designation |
Professor and Head |
| Affiliation |
Government Institute of Medical Sciences(GIMS) |
| Address |
Department of Anatomy
GIMS, Greater Noida
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
7701807013 |
| Fax |
|
| Email |
ranjanaverma318@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prerna Jain |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences(GIMS) |
| Address |
Department of Anatomy
GIMS, Greater Noida
Kasna, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9891390487 |
| Fax |
|
| Email |
drprernajain98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prerna Jain |
| Designation |
PG Student |
| Affiliation |
Government Institute of Medical Sciences(GIMS) |
| Address |
Department of Anatomy
GIMS, Greater Noida
Kasna, Greater Noida
UTTAR PRADESH
201310
India |
| Phone |
9891390487 |
| Fax |
|
| Email |
drprernajain98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences (GIMS) Kasna Greater Noida Gautam Buddha Nagar Uttar Pradesh Pin 201310 |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences (GIMS) |
| Address |
Government Institute of Medical Sciences (GIMS) Kasna Greater Noida Gautam Buddha Nagar Uttar Pradesh Pin 201310 |
| 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 |
| Dr Prerna Jain |
Government Institute of Medical Sciences |
Department of Anatomy
Ground floor, Academic block Gims Hospital Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9891390487
drprernajain98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GIMS Greater Noida |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G549||Nerve root and plexus disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Cadavers received in the Department of Anatomy, GIMS, Greater Noida under Uttar Pradesh Anatomy Act, 1956.
2.Properly embalmed adult human lower limb specimens.
|
|
| ExclusionCriteria |
| Details |
1.Specimens exhibiting signs of previous surgeries in the area of interest.
2.Specific lower limb deformities seen externally.
3.Incomplete anatomical structures.
4.Inadequate tissue preservation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To see Location of SN and PN 4
Zone A/B/C
2. Morphometric parameters
-To measure the diameter of SN and PN at the exit of GSF
-To measure the diameter of SN and PN at the level of IS.
-To measure the distance between SN and PN at the exit of GSF
-To measure the distance between SN and PN at the level of IS
-Cross-sectional areas (CA) of both nerves
3.Microanatomy of SN and PN |
At the time of dissection at baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
30/10/2025 |
| 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) |
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
|
Damage to nerves arising from sacral plexus including sciatic nerve (SN) and pudendal nerve (PN) can greatly compromise bowel, bladder, and sexual functions and may also result in severe motor dysfunction in the lower extremities.1 Incontinence happens when the external anal and vaginal sphincters lose their nerve supply because of damage to the sacral nerve.2 The complexity of sacral plexus injuries poses significant challenges to functional reconstruction by limiting available surgical options. As a result, there is scarcity of data suggesting treatment strategies that are currently applicable in clinical practice, often leading to suboptimal and incomplete functional recovery. Some surgical methods including direct anastomosis and nerve transfer have been established recently and show some purposeful recoveries in case of bladder and bowel incontinence. |