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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  
AIIMS Rishikesh 
 
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  
Name  Address 
nil  nil 
 
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  
Status 
Not Applicable 
 
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.

 
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