| CTRI Number |
CTRI/2025/03/082155 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/01/2026 |
| 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
|
Laparoscopic Adnexal Surgery Versus Open Adnexal Surgery For Adnexal Masses |
|
Scientific Title of Study
|
Comparative Study Of Laparoscopic Adnexal Surgery Versus Open Adnexal Surgery For Adnexal Masses |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JAVVAJI KAVITHA |
| Designation |
Junior resident (Post Graduate) |
| Affiliation |
SHRI B.M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE AND HOSPITAL |
| Address |
OBG OPD NO2,Department of OBG Shri B.M patil medical college hospital and research centre Bangaramma sajjan campus, Solapur road,Vijayapura 586103
Bijapur
Bijapur
KARNATAKA
586103
India |
| Phone |
6305416149 |
| Fax |
|
| Email |
javvajikavitha1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Shobha Shiragur |
| Designation |
Professor |
| Affiliation |
SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
OBG OPD NO 2,Department of OBG Shri B.M Patil medical college hospital and research centre Bangaramma sajjan, campus Solapur road, Vijayapura 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9663330846 |
| Fax |
|
| Email |
shobha.shiragur@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
JAVVAJI KAVITHA |
| Designation |
Junior resident (Post Graduate) |
| Affiliation |
SHRI B.M PATIL MEDICAL COLLEGE AND HOSPITAL |
| Address |
OBG OPD NO2,Department of OBG ShriB.M patil medical college hospital and reasearch centre Bangaramma sajjan campus,Solapur road, Vijayapura 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
6305416149 |
| Fax |
|
| Email |
javvajikavitha1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| OBG OPD NO 2 Shri B.M Patil medical college hospital and research centre, Bangaramma sajjan campus, Solapur road, vijayapura 586103 |
|
|
Primary Sponsor
|
| Name |
SHRI BM PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
OPD NO2,Department of OBG Shri B.M patil medical college hospital and research centre ,Bangaramma sajjan campus,Solapur road, VIJAYAPURA 586103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 JAVVAJI KAVITHA |
SHRI B.M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
OBG OPD NO2, Shri B.M patil medical college hospital and research centre, Bangaramma sajjan campus, Solapur road, vijayapura 586103
Bijapur
KARNATAKA |
6305416149
javvajikavitha1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical clearance committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N709||Salpingitis and oophoritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LAPAROSCOOPIC ADNEXAL SURGERY FOR ADNEXAL MASSES |
GROUP A - Patients who will undergo Laparoscopic surgery for adnexal masses |
| Comparator Agent |
OPEN ADNEXAL SURGERY FOR ADNEXAL MASSES |
GROUP B- Patients who will undergo Laparotomy(open surgery) for adnexal masses |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women with adnexal masses undergoing surgery either laparoscopy or laparotomy |
|
| ExclusionCriteria |
| Details |
Women with Abnormal uterine bleeding
Women with fibroids
Women with malignancies like carcinoma cevix and carcinoma endometrium
Haemodynamically instable patients
Cardiac failure, Liver failure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare post operative complications and duration of hospital stay in women undergoing laparoscopic adnexal surgery versus open adnexal surgery |
To compare post operative complications and duration of hospital stay in women undergoing laparoscopic adnexal surgery versus open adnexal surgery at the time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare duration of procedure, duration of anesthesia, post operative pain, cost of procedurein women undergoing laparascopic adnexal surgery and open adnexal surgery |
To compare duration of procedure,duration of anesthesia,postoperative pain, cost of procedure at the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This Randomised control study will be done in the Department of Obstetrics and Gynaecology BLDE (DU) SHRI B.M. Patil Medical College Hospital and Research Centre, Vijayapura, Karnataka, India. Women who are attending Obstetrics and Gynaecolology OPD are considerd for surgery.
GROUP A - Patients who will undergo Laparoscopic surgery for adnexal masses.
GROUP B - Patients who will undergo Laparotomy (open surgery) for adnexal masses. |