Non-descent vaginal hysterectomy versus laparoscopic/ open hysterectomy for benign gynaecological diseases: A systematic review and meta-analysis.

Study Question: Among women undergoing hysterectomy for benign gynaecological diseases, how does non-descent vaginal hysterectomy compare with laparoscopic or open hysterectomy in terms of operative, postoperative, and long-term outcomes? What is already known The hysterectomy is one of the most commonly performed gynaecological surgeries. Different routes of hysterectomy have been used depending upon the indication for surgery, expertise of the surgeon, infrastructure available and patient preferences. Open (abdominal) hysterectomy has been considered to be a safer route over the centuries, owing to the ease and convenience offered by the large abdominal incision. But, with the introduction of enhanced recovery, there has been a re-emphasis on the concept of the least invasive route for benign conditions. Vaginal route offers and advantage of least invasiveness, utilising the natural passage for performing surgeries, no scar and early recovery. With laparoscopy surgery gaining its popularity over last few decades, there is greater interest, both on the part of surgeons and patients, in this route of surgery. Laparoscopy is shown to lead y enhanced recovery and less blood loss compared to open surgery, but, at the same time, increased operative duration and risk of surgical injuries. Search Strategy A systematic literature search on PubMed, EMBASE, Scopus, Cochrane Library and Clinical trials.gov will be done to extract data for the articles and studies published between 1st January 2001 and 31st December 2025. Only full text articles in English language will be included. We will conduct a systematic literature search on PubMed, Embase, Scopus, Cochrane Library and Clinical trials.gov, to extract data for the published articles. The following keywords will be used to retrieve the studies: Participants, setting and methods The studies will be filtered according to eligibility criteria and duplicate studies will be removed. Inclusion Criteria The studies with the following test & control populations will be included. Participants: women undergoing hysterectomy by vaginal route for indications other than UV prolapse (non-descent vaginal hysterectomy) for benign gynaecological conditions. Exclusion criteria Hysterectomy for benign conditions by abdominal (open)route or laparoscopic route. Vaginal hysterectomy for prolapse. Outcomes Primary Outcome: 1. Post-operative recovery- ambulation time (hours), time to routine activities (weeks) 2. post-operative pain (at day 1, day 2, day 3 post-op)- VAS scoe, number of analgesic doses, Secondary Outcome: 3. Introperative and post-operative complications (infection- systematic and wound, febrile morbidity, return to theatre, need for conversion to laparotomy, duration of hospital stay, mortality, vaginal bleeding, vault infection, paralytic ileus, DVT) 4. Blood loss during surgery (drop in Hb level, need for blood transfusion) 5. UTI , urinary retention 6. Operative duration Protocol and Registration The protocol will be prospectively registered at OSF. The recommendations of the Cochrane Handbook for Systematic Reviews of Interventions guidelines and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) will be followed. The deadline for publication is set at December 31, 2025. There is no requirement for approval from an ethical committee. Data screening and extraction Two independent reviewers (Dr. HK and Dr. MM) will retrieve the studies separately and simultaneously. The studies will be filtered according to inclusion and exclusion criteria and duplicate studies will be removed. Only full-text articles will be included. Any conflict will be discussed and resolved with the third reviewer (Dr. SP). All decisions will be recorded in Microsoft word. In case of any doubt or questions about the original data, the review team will contact the corresponding author by email. In case of any doubt or questions about the original data, the review team will contact the corresponding author by email. For missing data, study investigators will be contacted via email for providing those details. The following data will be extracted from the selected studies: study design, comparator, sample size, study duration (start and end dates), eligibility criteria, data regarding demographic characteristics of pts included (age, parity, BMI), study design, year of study, geographical region, indication for surgery, number of participants, size of uterus, previous pelvic surgery, co-morbidity if any, time to recover, cost, tolerance of normal diet Assessment of risk of bias and quality of studies For the RCTs the risk of bias will be assessed according to the Cochrane Collaboration Network Risk Assessment Tool, the biases could be selection bias, performance bias, detection bias, attrition bias, reporting bias, and publication bias. The bias will be assessed at the outcome level. Funnel plot will be drawn using RevMan version 5.4. Each of the two reviewers will assess this risk of bias using the Cochrane tool. Two assessors (Dr HK and MM) will score every publication, which will then be compared to arrive at a consensus. In case of a difference in opinions, this will be documented and resolved with the help of a third assessor (Dr. SP). The Newcastle-Ottawa Scale for cohort study, will be used for assessment of study quality and risk of bias in case of observational studies. Each of the two reviewers will assess the risk of bias. In case of any discrepancy, opinion of the third reviewer will be sought to resolve the issue. Statistical analysis For continuous variables, the mean difference will be used, while the odds ratio or risk ratio will be used for dichotomous data. For effect sizes, a confidence interval of 95% and a p-value < 0.05 will be used for statistical significance. Heterogeneity will be evaluated using the I2 statistic, and based on its value, a fixed or random effect model will be used for analysis. All analyses will be done using R version 4.0.5 or STATA version 15. Subgroup analysis Following subgroup will be analysed separately 1. NDVH versus abdominal hysterectomy 2. NDVH versus laparoscopic hysterectomy Study Funding: None

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