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Comparative Study of LAVH and Minilaparotomy Hysterectomy (LAVH)

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ClinicalTrials.gov Identifier: NCT03548831
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Abhilasha Agarwal, Manipal University

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.

Condition or disease
Hysterectomy Minimal Invasive Surgery Benign Gynecologic Neoplasm

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).


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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparative Study of Laparoscopic Assisted Vaginal Hysterectomy and Minilap Hysterectomy for Benign Gynaecological Conditions
Actual Study Start Date : August 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Group/Cohort
MLH
Minilaparotomy Hysterectomy
LAVH
Laparoscopic Assisted Vaginal Hysterectomy



Primary Outcome Measures :
  1. Duration of surgery [ Time Frame: Intra operatively ]
    All surgeries were performed by two gynecologists with an almost equal level of surgical competence.

  2. Blood loss [ Time Frame: Intra operatively ]
    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.

  3. Postoperative pain [ Time Frame: Starting from immediate post-operative period till 72 hours. ]

    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.



Secondary Outcome Measures :
  1. Weight of uterus [ Time Frame: Intra operatively ]
    In grams unit

  2. Intra-operative complications [ Time Frame: Intra-operatively ]
    Visceral injury such as bladder/ ureter / bowel injury

  3. Conversion rate [ Time Frame: Intraoperatively ]
    Conversion to conventional laparotomy

  4. Post operative complications [ Time Frame: Upto 1 month ]
    Secondary haemorrhage, Urinary Tract Infection, Urinary retention, Wound infection, Thrombo-embolic complications, Febrile morbidity

  5. Duration of hospital stay [ Time Frame: Upto 1 month ]
    In days


Other Outcome Measures:
  1. BMI [ Time Frame: Pre operatively ]
    Weight and height will be combined to report BMI in kg/m^2



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Benign gynaecological conditions
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548831


Sponsors and Collaborators
Manipal University
Investigators
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Principal Investigator: Abhilasha Agarwal, MS Manipal University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abhilasha Agarwal, Junior Resident, Manipal University
ClinicalTrials.gov Identifier: NCT03548831     History of Changes
Other Study ID Numbers: IEC 429/2014
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: All IPD that underlie results in a publication maybe shared after sponsor approval. Present status - undecided.

Keywords provided by Abhilasha Agarwal, Manipal University:
Minilaparotomy
Hysterectomy
Laparoscopic assisted vaginal hysterectomy
Benign
Gynaecology

Additional relevant MeSH terms:
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Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms