Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access

Pain Clinical Trial

Official title:

Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03373513
• Other study ID #: R-SSH
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2018
• Source: Herning Hospital
• Contact: Finn F Lauszus, MD,PhD
• Phone: 28495640
• Email: finlau[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

robotic single site surgery (R-SSH) is a novel technique, which may be superior to conventional multiport hysterectomy in select patients regarding cosmesis and postoperative pain. We, perform a randomized trial to compare R-SSH with multiport laparoscopic hysterectomy with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.

Description:

The study is scheduled to start February 2018 and compares robotic single-site hysterectomy to conventional multiport hysterectomy. Procedures are performed by an experienced two-surgeon team. Patients are randomized to either conventional multiport hysterectomy (N=62) or R-SSH (N=62). Eligibility criteria are the same as for study 1. Patient's satisfaction with body image and cosmesis is assessed at different time points pre- and postoperatively by means of validated cosmesis scales and Body Image Questionnaire. Postoperative pain and analgesia use will be registered as well as secondary outcome parameters as described above. A follow-up at 1, 3 and 6 month include evaluation of the scar and registration of port-site hernias and vaginal dehiscence or other complications. Interviews and diaries will include time of return to home and work, daily activities including sexuality The R-SSH is performed using da Vinci, Xi robotic system. One single port, diameter 2 cm is applied. Applying an additional assistant port is defined conversion of procedure The laparoscopy is performed using our standard equipment and 4 trocars, 5 mm each.

Socio-economical consequences of R-SSH versus conventional laparoscopic hysterectomy Study details in preparation

Sample size calculation was based a previous study on fast track hysterectomy, which showed a difference in return to work of 4 days. 62 women in each group is needed with standard deviation ±8 and a power of 80%. To include those not working, we calculated that with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group the sample was sufficient to detect of difference of 0.1 in visual analog pain score with a power of 80%. All calculation are based on two-sided testing with alpha of 0.05.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: December 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hysterectomy on benign indication,

• American Society of Anesthetists group 1 or 2,

• BMI less than 35 kg/m2

• uterine size less than 300 g estimated by ultrasound, using Ferraris formula.

Exclusion Criteria:

• adhesions

• prior extensive abdominal surgery

• prior midline incision,

• cutis laxa of abdomen surgery

• endometriosis

• more than 1 cesarean section

• malignant disease

Related Conditions & MeSH terms

• Activity, Motor
• Pain
• Wound

Intervention

Procedure:
• Robotic single-site Hysterectomy
Robotic assisted Periumbilical single incision hysterectomy
• Laparoscopic hysterectomy
Multiport laparoscopic hysterectomy

Locations

Country	Name	City	State
Denmark	Gynecology Dept. Herning Hospital	Herning

Sponsors (1)

Lead Sponsor	Collaborator
Herning Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;(8):CD003677. doi: 10.1002/14651858.CD003677.pub5. Review. — View Citation

El Hachem L, Andikyan V, Mathews S, Friedman K, Poeran J, Shieh K, Geoghegan M, Gretz HF 3rd. Robotic Single-Site and Conventional Laparoscopic Surgery in Gynecology: Clinical Outcomes and Cost Analysis of a Matched Case-Control Study. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):760-8. doi: 10.1016/j.jmig.2016.03.005. Epub 2016 Mar 15. — View Citation

Golkar FC, Ross SB, Sperry S, Vice M, Luberice K, Donn N, Morton C, Hernandez JM, Rosemurgy AS. Patients' perceptions of laparoendoscopic single-site surgery: the cosmetic effect. Am J Surg. 2012 Nov;204(5):751-61. doi: 10.1016/j.amjsurg.2011.07.026. — View Citation

Sandberg EM, la Chapelle CF, van den Tweel MM, Schoones JW, Jansen FW. Laparoendoscopic single-site surgery versus conventional laparoscopy for hysterectomy: a systematic review and meta-analysis. Arch Gynecol Obstet. 2017 May;295(5):1089-1103. doi: 10.1007/s00404-017-4323-y. Epub 2017 Mar 29. Review. — View Citation

Yeung PP Jr, Bolden CR, Westreich D, Sobolewski C. Patient preferences of cosmesis for abdominal incisions in gynecologic surgery. J Minim Invasive Gynecol. 2013 Jan-Feb;20(1):79-84. doi: 10.1016/j.jmig.2012.09.008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return-to-work	Time from operation to return work	up to six months after operation or until work is resumed, whichever came first
Secondary	Pain measured by subjective score	Visual analogue pain score with a minimum of '0' up to '10' on a 10 cm continious scale	Visual analogue pain score first, second, third, fourth, fifth, and six months after operation