Hysterectomy Clinical Trial
— LAVHOfficial title:
Comparative Study of Laparoscopic Assisted Vaginal Hysterectomy and Minilap Hysterectomy for Benign Gynaecological Conditions
NCT number | NCT03548831 |
Other study ID # | IEC 429/2014 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | June 2016 |
Verified date | May 2018 |
Source | Manipal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Minilaparotomy hysterectomy (MLH) relies on the simplicity of traditional open technique of abdominal hysterectomy, imparts cosmesis and faster recovery of laparoscopic hysterectomy yet avoids the long learning curve, cost of expensive setup and instrumentation associated with the minimally invasive approaches namely laparoscopy and robotics. In the present study, we tried to ascertain if the results obtained with MLH can be compared to LAVH in terms of its feasibility, intraoperative variables, and complications. The null hypothesis was that both MLH and LAVH are comparable techniques, so where cost and surgeon's experience are the confining issues, patients can be reassured that MLH gives comparable results.
Status | Completed |
Enrollment | 52 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Non descent uterus with benign gynaecological conditions Exclusion Criteria: - Uterine size > 20 weeks - Minilaparotomy was contraindicated in patients where severe adhesions might exist eg - - Endometriosis - Previous pelvic inflammatory disease - Patients with one or more contraindications for LAVH were excluded - - Cardiac or respiratory morbidity contraindicating laparoscopy - Frozen pelvis - Cervix flushed with vagina |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Manipal University |
Fanfani F, Fagotti A, Longo R, Marana E, Mancuso S, Scambia G. Minilaparotomy in the management of benign gynecologic disease. Eur J Obstet Gynecol Reprod Biol. 2005 Apr 1;119(2):232-6. — View Citation
Garry R, Fountain J, Brown J, Manca A, Mason S, Sculpher M, Napp V, Bridgman S, Gray J, Lilford R. EVALUATE hysterectomy trial: a multicentre randomised trial comparing abdominal, vaginal and laparoscopic methods of hysterectomy. Health Technol Assess. 2004 Jun;8(26):1-154. — View Citation
Hoffman MS, Lynch CM. Minilaparotomy hysterectomy. Am J Obstet Gynecol. 1998 Aug;179(2):316-20. — View Citation
Pelosi MA 2nd, Pelosi MA 3rd. Pelosi minilaparotomy hysterectomy: a non-endoscopic minimally invasive alternative to laparoscopy and laparotomy. Surg Technol Int. 2004;13:157-67. Review. — View Citation
Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007 Nov;110(5):1091-5. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | BMI | Weight and height will be combined to report BMI in kg/m^2 | Pre operatively | |
Primary | Duration of surgery | All surgeries were performed by two gynecologists with an almost equal level of surgical competence. | Intra operatively | |
Primary | Blood loss | Total amount of blood loss was calculated during both the methods. It was calculated by adding up the mop count (one fully soaked mop ~ 50 ml of blood loss) and the amount of fluid in the suction pump minus the saline used for irrigation. | Intra operatively | |
Primary | Postoperative pain | There are various methods to score pain. In our study, we used visual analogue scale for the scoring. The pain was scored every 6th hourly for the first 24hrs and thereafter 24th hourly till 72 hrs. The Visual Analogue Scale (VAS) (Figure 14) is a scoring scale on which the patient rates his/her pain on a scale of 0 to 10, 0 representing no pain and 10 representing excruciating or intolerable pain. The scoring is subjective and gives the patient freedom to choose the intensity of the pain as per their perception. |
Starting from immediate post-operative period till 72 hours. | |
Secondary | Weight of uterus | In grams unit | Intra operatively | |
Secondary | Intra-operative complications | Visceral injury such as bladder/ ureter / bowel injury | Intra-operatively | |
Secondary | Conversion rate | Conversion to conventional laparotomy | Intraoperatively | |
Secondary | Post operative complications | Secondary haemorrhage, Urinary Tract Infection, Urinary retention, Wound infection, Thrombo-embolic complications, Febrile morbidity | Upto 1 month | |
Secondary | Duration of hospital stay | In days | Upto 1 month |
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