Post Operative Morbidity in Laparoscopic Vs Transvaginal cuff closure after Total Laparoscopic Hysterectomy - A Double blind Randomised controlled trial

After a detailed history and physical examination of a female more than 40 years and considering inclusion and exclusion criteria, patients will be recruited for the study. A participant information sheet will be given to the patients and after a verbal explanation about the study, written informed consent in patient’s vernacular language will be taken. A case record form will be used for collecting the data. The demographic history of patient will be noted. Menstrual history, contraceptive history, obstetric history, personal and family history will be asked. A detailed examination of the patient will be done which will include general physical examination, respiratory, cardiovascular, abdominal examination and pelvic examination which will include per speculum, per vaginum examination, if required. All routine investigations like complete blood count (CBC), Random blood sugar (RBS), urine routine and microscopy (URINE R/M), serum electrolytes (SE), liver function test (LFT), blood group (ABORH), prothrombin tine/international normalized ratio (PT/INR), viral markers, and ultrasonography if required will be done. 11 Randomisation will be done by using computer generated random number tables. It will be a double blind randomized controlled trial . In this patient undergoing TLH and observer who will observe patient on follow up will be blind , hence double blind randomized controlled trial . All eligible participants who will give consent for the study will be randomly allocated to group A undergoing Laparoscopic cuff closure) or group B (undergoing Transvaginal cuff closure). Preoperative patient preparation, surgical methods, and postoperative patient care will be comparable. Their descriptive medical records and thorough patient details in their personal files will be maintained. At the time of discharge, the patients will be advised to avoid coitus for 2 weeks and heavy weight lift for 6 weeks. The patients will be asked to follow‑up after 1 week, one month, and thereafter three months, if no other indication for frequent visits. The 3 month follow-up period has been chosen because it has shown that almost all vaginal cuff dehiscences after TLH occur within 2 months after surgery. Assessment of vaginal cuff complications will be done either subjectively or objectively. This complications include vaginal cuff dehiscence , post operative vaginal bleeding , vaginal cuff hematoma and post operative infections .

Detection of vaginal complications will be conducted through:

• An objective assessment during the follow-up appointment

• Information from hospital admissions, emergency department visits, or physician evaluations within the 3-month follow-up period, gathered during recent medical history assessment.