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Clinical Trials/CTRI/2022/01/039299
CTRI/2022/01/039299Not yet recruitingNot Applicable

Effects of Horizontal vs Vertical Vaginal Cuff Closure Techniques on Vagina Length and Sexuality after Vaginal Hysterectomy: -a randomized controlled trial.

Department of obs gynae AIIMS Rishikesh1 site in 1 country50 target enrollmentStarted: January 18, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, immediate postoperatively at 4-6 weeks postoperatively

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •Malignant pelvic organ prolapse suspicious to be malignant.

Outcomes

Primary Outcomes

The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, immediate postoperatively at 4-6 weeks postoperatively

Time Frame: 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]

Time Frame: 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 Outcomes

  • Intraoperative observation including:(1. Operative time)

Investigators

Sponsor
Department of obs gynae AIIMS Rishikesh
Sponsor Class
Research institution and hospital

Study Sites (1)

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