Clinical trial NCT03548831: Comparative Study of LAVH and Minilaparotomy Hysterectomy
Official title: Comparative Study of Laparoscopic Assisted Vaginal Hysterectomy and Minilap Hysterectomy for Benign Gynaecological Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hysterectomy
Minimal Invasive Surgery
Benign Gynecologic Neoplasm
Keywords: Minilaparotomy
Hysterectomy
Laparoscopic assisted vaginal hysterectomy
Benign
Gynaecology
Lead sponsor: Manipal University
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 52
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are admitted in the Department of OBG, Kasturba Hospital, Manipal for hysterectomy for benign gynaecological disorders with non descent uterus.

Brief summary: 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.

Detailed description: Around 600,000 hysterectomies are performed every year in the United States, making hysterectomy the second most common surgery for women, first being cesarean section. Most of the hysterectomies are done for non cancerous conditions. And the most common indication for the same is symptomatic fibroid uterus.

In spite of being the most common gynaecological surgery the route of hysterectomy has always been an issue of debate since early 19th century. In the beginning it started as vaginal hysterectomy which soon was taken over by laparotomy route. With the advent of laparoscopy as the recent minimally invasive route the choices have further increased. Laparoscopic route has prompted the need for development of other forms of hysterectomy which are minimally invasive and are associated with less perioperative morbidity with better postoperative outcomes. Abdominal route includes both conventional and minilaparotomy; laparoscopic route includes both Laparoscopic Assisted Vaginal Hysterectomy (LAVH) as well as Total Laparoscopic Hysterectomy (TLH). Each method has its own advantages and disadvantages. The vaginal route is preferable because it is associated with less perioperative morbidity and faster recovery. Although laparoscopic route offers minimally invasive alternative to abdominal hysterectomy when vaginal route is contraindicated (In case of huge fibroid uterus or patients with pelvic pathology), it has its own drawbacks. The laparoscopic instruments are costly, there is a long learning curve involved in the training, and the operating time with this route is prolonged.

The EVALUATE study suggested that majority of surgeons(67%) preferred abdominal approach as the route of surgery, especially when dealing with pelvic pathology. Hence, minilaparotomy hysterectomy as an alternative minimally invasive surgery method was started. It relies on traditional open techniques and inexpensive instrumentation, making it significantly faster than laparoscopy and easy to perform. Hoffman et al found minilaparotomy hysterectomy procedure effective and safe in non-obese women in whom vaginal approach was contraindicated. Fanfani et al did a retrospective analysis on 252 patients who underwent minilaparotomy hysterectomy and found it to be a feasible route of surgery in benign gynaecological conditions with operative time similar or shorter as compared to vaginal, laparotomy and laparoscopy surgery. Few surgeons have modified the incision depending on the their experience which led to development of Pelosi method of Minilaparotomy Hysterectomy in 2003.

The final choice of the route and method depends on multiple factors which include indication of surgery, size of fibroid, equipments available in the surgical set up, surgeons' expertise, patient's financial background.

All patients followed the same standard pre-operative protocol. All surgeries were performed under general anesthesia with endotracheal intubation. Demographic details that included age, parity, body mass index (BMI), baseline investigations, diagnosis, and co-morbidities, were collated a day prior to the day of surgery. On admission, patients were informed in detail about the operation modalities and the associated complications. Patients along with their relatives were counselled about the advantages and disadvantages of both the surgical methods and the final decision was made on a joint consensus between the surgeon and the patient, following which an informed written consent was obtained.

The aim of the study was to compare the feasibility of two minimally invasive surgical procedures in low resource settings (such as India) - Laparoscopic assisted vaginal hysterectomy (LAVH) and Minilaparotomy hysterectomy (transverse suprapubic incision \<7cm).

Eligibility criteria: 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

Primary outcomes:
measure: Duration of surgery
timeFrame: Intra operatively
measure: Blood loss
timeFrame: Intra operatively
measure: Postoperative pain
timeFrame: Starting from immediate post-operative period till 72 hours.
Secondary outcomes:
measure: Weight of uterus
timeFrame: Intra operatively
measure: Intra-operative complications
timeFrame: Intra-operatively
measure: Conversion rate
timeFrame: Intraoperatively
measure: Post operative complications
timeFrame: Upto 1 month
measure: Duration of hospital stay
timeFrame: Upto 1 month
Other outcomes:
measure: BMI
timeFrame: Pre operatively
Locations:
Study officials:
affiliation: Manipal University
name: Abhilasha Agarwal, MS
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1097/01.AOG.0000285997.38553.4b.
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. doi: 10.3310/hta8260.
citation: Hoffman MS, Lynch CM. Minilaparotomy hysterectomy. Am J Obstet Gynecol. 1998 Aug;179(2):316-20. doi: 10.1016/s0002-9378(98)70358-8.
citation: 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. doi: 10.1016/j.ejogrb.2004.07.040.
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.
citation: Agarwal A, Shetty J, Pandey D, Jain G. Feasibility and Compatibility of Minilaparotomy Hysterectomy in a Low-Resource Setting. Obstet Gynecol Int. 2018 Aug 1;2018:8354272. doi: 10.1155/2018/8354272. eCollection 2018.