Comparative Study of LAVH and Minilaparotomy Hysterectomy

NCT03548831 | Completed DMC

• 1 other identifier: IEC 429/2014
• Study Type: observational
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hysterectomy; Minimal Invasive Surgery; Benign Gynecologic Neoplasm

Keywords

Minilaparotomy; Hysterectomy; Laparoscopic assisted vaginal hysterectomy; Benign; Gynaecology

Outcome Measures

Primary Outcomes (3)

• Duration of surgery

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

  Intra operatively

• 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

• 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 Outcomes (5)

• Weight of uterus

  Intra operatively

• Intra-operative complications

  Intra-operatively

• Conversion rate

  Intraoperatively

• Post operative complications

  Upto 1 month

• Duration of hospital stay

  Upto 1 month

Other Outcomes (1)

• BMI

  Pre operatively

Study Arms (2)

MLH

Minilaparotomy Hysterectomy

LAVH

Laparoscopic Assisted Vaginal Hysterectomy

Eligibility Criteria

• Gender Eligibility Details: Benign gynaecological conditions
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Non descent uterus with benign gynaecological conditions

You may not qualify if:

• 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

Sponsors & Collaborators

• Manipal University: lead

Related Publications (6)

• 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.

  PMID: 17978124 BACKGROUND

• 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.

  PMID: 15215018 BACKGROUND

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

  PMID: 9731832 BACKGROUND

• 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.

  PMID: 15808386 BACKGROUND

• 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.

  PMID: 15744686 BACKGROUND

• 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.

  PMID: 30154857 DERIVED

Study Officials

• Abhilasha Agarwal, MS

  Manipal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Resident

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: June 7, 2018
• Study Start: August 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 7, 2018

Record last verified: 2018-05