Clinical trial · Observational

Comparative Study of LAVH and Minilaparotomy Hysterectomy

Comparative Study of Laparoscopic Assisted Vaginal Hysterectomy and Minilap Hysterectomy for Benign Gynaecological Conditions

NCT03548831CI-TRIAL-00033234LAVHcompletedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Benign Gynecologic Neoplasm	Benign Female Reproductive System Neoplasm	ALIAS	0.90
Hysterectomy	—	UNRESOLVED	—
Minimal Invasive Surgery	—	UNRESOLVED	—

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
MLH
description
Minilaparotomy Hysterectomy
label
LAVH
description
Laparoscopic Assisted Vaginal Hysterectomy

Primary outcomes (3)

measure
Duration of surgery
timeFrame
Intra operatively
description
All surgeries were performed by two gynecologists with an almost equal level of surgical competence.
measure
Blood loss
timeFrame
Intra operatively
description
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.

Eligibility

Eligibility (as posted)

Sex: Female

Show eligibility criteria text

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

References

Publications (6)

BACKGROUNDWu 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
BACKGROUNDGarry 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
BACKGROUNDHoffman 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
BACKGROUNDFanfani 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
BACKGROUNDPelosi 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
DERIVEDAgarwal 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