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CompletedNCT03548831LAVHUpdated Jun 7, 2018

Comparative Study of LAVH and Minilaparotomy Hysterectomy

An observational study in Hysterectomy, Minimal Invasive Surgery and Benign Gynecologic Neoplasm, sponsored by Manipal University. Completed. Open to female participants. Per ClinicalTrials.gov, last updated 2018-06-07.

Sponsored by Manipal University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
52
Sex
Female
01

Study 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.

Read the 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).

02

Conditions studied

  • Hysterectomy
  • Minimal Invasive Surgery
  • Benign Gynecologic Neoplasm

Keywords

  • Minilaparotomy
  • Hysterectomy
  • Laparoscopic assisted vaginal hysterectomy
  • Benign
  • Gynaecology
03

In context

Genital Neoplasms, Female

81 studies on the registry are indexed under Genital Neoplasms, Female; 18 are open to participants now.

This study's enrollment of 52 is below the median of 350 across 16 observational studies indexed under Genital Neoplasms, Female.

Browse Genital Neoplasms, Female studies →

Lead sponsor

Manipal University is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Non descent uterus with benign gynaecological conditions

Exclusion criteria

Exclusion Criteria:

  • Uterine size > 20 weeks
  • Minilaparotomy was 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
52 participants (actual)
Patient registry
No

Groups and cohorts

  • MLH

    Minilaparotomy Hysterectomy

  • LAVH

    Laparoscopic Assisted Vaginal Hysterectomy

06

What researchers measure

Primary outcomes

  1. Duration of surgery

    All surgeries were performed by two gynecologists with an almost equal level of surgical competence.

    Time frame: Intra operatively

  2. 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.

    Time frame: Intra operatively

  3. 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.

    Time frame: Starting from immediate post-operative period till 72 hours.

Secondary outcomes

  1. Weight of uterus

    In grams unit

    Time frame: Intra operatively

  2. Intra-operative complications

    Visceral injury such as bladder/ ureter / bowel injury

    Time frame: Intra-operatively

  3. Conversion rate

    Conversion to conventional laparotomy

    Time frame: Intraoperatively

  4. Post operative complications

    Secondary haemorrhage, Urinary Tract Infection, Urinary retention, Wound infection, Thrombo-embolic complications, Febrile morbidity

    Time frame: Upto 1 month

  5. Duration of hospital stay

    In days

    Time frame: Upto 1 month

Other outcomes

  1. BMI

    Weight and height will be combined to report BMI in kg/m\^2

    Time frame: Pre operatively

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 17978124 ↗
  • 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. PubMed 15215018 ↗
  • Hoffman MS, Lynch CM. Minilaparotomy hysterectomy. Am J Obstet Gynecol. 1998 Aug;179(2):316-20. doi: 10.1016/s0002-9378(98)70358-8. PubMed 9731832 ↗
  • 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. PubMed 15808386 ↗
  • 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. PubMed 15744686 ↗
  • 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. PubMed 30154857 ↗

Individual participant data

Plan to share: Undecided — All IPD that underlie results in a publication maybe shared after sponsor approval. Present status - undecided.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2014 to primary completion in Jun 2016, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2018
First posted
Jun 7, 2018
StartActual
Aug 2014
Primary completionActual
Jun 2016
CompletionActual
Jun 2016
Last update
Jun 7, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03548831
Lead sponsor
Manipal University
Responsible party
Abhilasha Agarwal (Junior Resident, Manipal University) — Principal investigator
First posted
Jun 7, 2018
Start date
Aug 2014
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jun 7, 2018

Study contacts

Abhilasha Agarwal, MS
principal investigator · Manipal University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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