| CTRI Number |
CTRI/2025/01/079568 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Anorectal Manometry Profile In Functional Constipation Or IBS-C: Insights From Eastern India |
|
Scientific Title of Study
|
Study Of Anorectal Manometry Profile Of Patients With Functional Constipation Or Constipation Predominant Irritable Bowel Syndrome In A Tertiary Care Center Of Eastern India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Probal Saha |
| Designation |
Post Doctorate Trainee Gastroenterology |
| Affiliation |
IPGMER AND SSKMH |
| Address |
4th floor, Ronald Ross Building, IPGMER and SSKM HOSPITAL, 244 AJC Bose Road, Kolkata
BURABURI TALA, POST OFFICE- MALDA,POLICE STATION- ENGLISH BAZAR, DISTRICT- MALDA, STATE- WESR BENGAL
Maldah
WEST BENGAL
700020
India |
| Phone |
9064379502 |
| Fax |
|
| Email |
sahaprobal2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arka Banerjee |
| Designation |
Associate Professor Department of Gastroenterology |
| Affiliation |
IPGMER AND SSKMH |
| Address |
4th Floor,Ronald Ross Building,IPGMER and SSKM HOSPITAL, 244 AJC Bose Road, KOLKATA
4th Floor,Ronald Ross Building,IPGMER and SSKM HOSPITAL, 244 AJC Bose Road, KOLKATA
Kolkata
WEST BENGAL
700020
India |
| Phone |
9433454747 |
| Fax |
|
| Email |
dr.arkobanerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Probal Saha |
| Designation |
Post Doctorate Trainee Gastroenterology |
| Affiliation |
IPGMER AND SSKMH |
| Address |
4th Floor,Ronald Ross Building, IPGMER and SSKM HOSPITAL, 244 AJC Bose Road,KOLKATA
BURABURI TALA, POST OFFICE- MALDA,POLICE STATION- ENGLISH BAZAR, DISTRICT- MALDA, STATE- WESR BENGAL
Maldah
WEST BENGAL
700020
India |
| Phone |
9064379502 |
| Fax |
|
| Email |
sahaprobal2@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital,4th floor Ronald Ross Building, 24 AJC Bose Road, Kolkata 700020 |
|
|
Primary Sponsor
|
| Name |
IPGMER and SSKM Hospital |
| Address |
4th floor Ronald Ross Building,IPGMER and SSKM Hospital, 24 AJC Bose Road, Kolkata 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 |
| PROBAL SAHA |
School of digestive and liver disease , IPGMER and SSKM Hospital |
Room no.2,Ground Floor, School of digestive and liver disease, IPGMER and SSKM Hospital, 244 AJC Bose road, Kolkata
Kolkata
WEST BENGAL |
9064379502
sahaprobal2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME AND R RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anorectal Manometry |
we will look for
Resting pressure(mmHg)
Squeeze pressure (mmHg)
Type of Dyssynergic defecation
Sensory Testing -
1.First sensation (ml)
2.Desire to defecate (ml)
3.Max tolerable volume (ml)
Rectal Hyposensitivity – Present / Absent
Rectoanal inhibitory response – Present / Absent
Balloon expulsion test – Normal/ Abnormal
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either gender and age group above 18 years and less than 65 years, chronic constipation of more than 6-month duration defined according to ROME IV criteria (with Bristol stool form I to III) and fulfilling the ROME IV criteria of Functional constipation or constipation-predominant irritable bowel syndrome.
2.Normal sigmoidoscopy/colonoscopy |
|
| ExclusionCriteria |
| Details |
Patients having Constipation due to secondary causes like mechanical obstruction and drugs.
Patients having diabetes mellitus (HbA1c more than 7.5)
Patients having thyroid disease (TSH value more than 7)
Patients having decompensate liver disease.
Patients having Stage 3 and above Chronic kidney disease
Patients having history of abdominal surgery except cholecystectomy and appendectomy
Patients having history of Gynecological surgery
Patients not giving consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Differences in anorectal manometry parameters between functional constipation and constipation predominant irritable bowel syndrome group.
|
At end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients with dyssynergia.
|
At end of study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
07/02/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Purpose of the study to evaluate the anorectal manometry profile of patients with functional constipation or constipation predominant irritable bowel syndrome. Initially basic details will be taken, question related to onset of symptoms, progression of symptoms and other relevant questions on present, past and personal details will be asked. Those who will fulfill inclusion criteria will be included in study. Subjects will be asked about their blood test reports and radiological investigations. Subject will undergo digital rectal examination, ultrasound of whole abdomen, colonoscopy/ sigmoidoscopy and anorectal manometry. After that difference in anorectal manometry between functional constipation and constipation predominant irritable bowel syndrome will be evaluated. |