| CTRI Number |
CTRI/2022/01/039299 [Registered on: 10/01/2022] Trial Registered Prospectively |
| Last Modified On: |
29/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Closure techniques in vaginal hysterectomy |
|
Scientific Title of Study
|
Effects of Horizontal vs Vertical Vaginal Cuff Closure Techniques on Vagina Length and Sexuality after Vaginal Hysterectomy: -a randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajlaxmi Mundhra |
| Designation |
Associate Professor |
| Affiliation |
aiims rishikesh |
| Address |
Department of Obs Gynae AIIMS Rishikesh Dehradun UTTARANCHAL 249203 India |
| Phone |
8057482137 |
| Fax |
|
| Email |
rmundhra54@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rajlaxmi Mundhra |
| Designation |
Associate Professor |
| Affiliation |
aiims rishikesh |
| Address |
Department of Obs Gynae AIIMS Rishikesh Dehradun UTTARANCHAL 249203 India |
| Phone |
8057482137 |
| Fax |
|
| Email |
rmundhra54@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Rajlaxmi Mundhra |
| Designation |
Associate Professor |
| Affiliation |
aiims rishikesh |
| Address |
Department of Obs Gynae AIIMS Rishikesh Dehradun UTTARANCHAL 249203 India |
| Phone |
8057482137 |
| Fax |
|
| Email |
rmundhra54@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of obs gynae AIIMS Rishikesh |
| Address |
Department of obs gynae AIIMS Rishikesh |
| 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 Rajlaxmi Mundhra |
AIIMS Rishikesh |
Department of Obs Gynae
AIIMS Rishikesh
Uttarakhand India
pin-249203
India Dehradun UTTARANCHAL |
08057482137
rmundhra54@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N813||Complete uterovaginal prolapse, (2) ICD-10 Condition: N811||Cystocele, (3) ICD-10 Condition: N812||Incomplete uterovaginal prolapse, (4) ICD-10 Condition: N818||Other female genital prolapse, (5) ICD-10 Condition: N816||Rectocele, (6) ICD-10 Condition: N815||Vaginal enterocele, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
vaginal cuff closure techniques |
either vertical or horizontal vaginal cuff closure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
All the cases of benign Pelvic organ prolapse with Stage 2 or higher (measured using pelvic organ prolapse quantification system) will be enrolled in the study |
|
| ExclusionCriteria |
| Details |
Malignant pelvic organ prolapse
suspicious to be malignant |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vaginal Length [ Time Frame: up to 4-6 weeks post-operative]
The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, immediate postoperatively at 4-6 weeks postoperatively
|
Vaginal Length [ Time Frame: up to 4-6 weeks post-operative]
The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, immediate postoperatively at 4-6 weeks postoperatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative observation including:
1. Operative time
2. Intraoperative blood loss
3. Number of stitches taken in closure of vaginal vault
4. Vault closure time
Post-operative:
1. Vaginal vault dehiscence/ Vault hematoma/ Granulation tissue
2. Bladder/Bowel complaints
3. Sexual Function [ Time Frame: Pre-operative and 3 months post-operatively]
Sexual function will be measured with PISQ_IR questionnaire (standardised validated questionnaire to assess sexual function in pelvic organ prolapse) preoperatively and at 3months post operatively.
-Follow up visits at 7-10 days, 6 weeks and 3 months.
|
intraoperative, 7-10 days, 6 weeks and 3 months |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
18/01/2022 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The American Association of Gynecologic Laparoscopists (AAGL) recommends that “most hysterectomies for benign disease should be performed either vaginally or laparoscopically.†PFDs (pelvic floor diseases) includes vaginal bulging, urinary or fecal incontinence, pelvic organ prolapse (POP), pelvic pain, pelvic pressure or a sense of heaviness, difficulties emptying the bladder, and other sensory and emptying abnormalities of the gastrointestinal tract. These complaints can cause sexual inactivity. Given the sensitive nature of prolapse with its effect on physical appearance of female genitals, particularly when the condition is advanced, it seems likely that such prolapse would render at least some women self-conscious. Major concern after POP surgery includes not only successful anatomical correction of any protrusion but also the impact of surgery on the quality of life including sexual life. Only a few prospective comparative studies on sexual function before and after POP surgery have been conducted, and only a few studies have attempted to define the optimal method of vaginal cuff closure after vaginal hysterectomy (VH). Those that have, have done so only in terms of the effects of the closure type on vaginal length; they did not assess the effects of various techniques on sexual functioning. To address this area, we prospectively evaluated sexual function in women before and after VH with McCall Culdoplasty and compared the effects of horizontal and vertical vaginal cuff closure on sexuality. |