Single Site Versus Multi Site Robotic Hysterectomy

NCT03662451 | Withdrawn DMC

• 1 other identifier: Single site robot study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Robotic single site surgery (R-SSH) is a novel technique, which may be superior to multi site hysterectomy (R-MSH) in select patients regarding cosmesis and postoperative pain. A randomized trial is performed to compare R-SSH with R-MSH with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.

Conditions

Rehabilitation; Pain, Postoperative; Wound Infection

Keywords

Return-to-work; Cosmesis; Visual analogue pain score

Outcome Measures

Primary Outcomes (1)

• Scar appearance and satisfaction

  Appearance and evaluation of scar by POSAS scale (see www.posas.org and reference below) which has a scale from 1-10, where 1 is minimum and 10 is maximum; on scar's pain, its itching, on difference from normal skin, on stiffness, on thickness, on irregularity and general satisfaction

  Six months after operation

Secondary Outcomes (1)

• Scoring of abdominal pain

  Visual analogue pain score at first, second, third, fourth, fifth, and sixth month after operation

Study Arms (2)

Robotic single-site hysterectomy

ACTIVE COMPARATOR

Robotic single-site hysterectomy is performed in this arm

Procedure: Robotic assisted hysterectomy

Robotic multi-site hysterectomy

ACTIVE COMPARATOR

Robotic multi-site hysterectomy is performed in this arm

Procedure: Robotic assisted hysterectomy

Interventions

Robotic assisted hysterectomy PROCEDURE

Periumbilical single incision vs multiple abdominal incisions for hysterectomy

Robotic multi-site hysterectomy; Robotic single-site hysterectomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hysterectomy on benign indication,
• American Society of Anesthetists group 1 or 2,
• BMI less than 30 kg/m2
• uterine size less than 300 g estimated by ultrasound, using Ferraris formula.

You may not qualify if:

• adhesions
• prior extensive abdominal surgery
• prior midline incision
• cutis laxa of abdomen surgery
• endometriosis
• more than 1 cesarean section
• malignant disease

Sponsors & Collaborators

• Herning Hospital: lead
• Herlev Hospital: collaborator

Study Sites (1)

Gynecology Dept. Herning Hospital

Herning, 7400, Denmark

Location

Related Publications (6)

• 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.

  PMID: 26992935 BACKGROUND

• 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.

  PMID: 23140831 BACKGROUND

• 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.

  PMID: 28357561 BACKGROUND

• 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.

  PMID: 23312246 BACKGROUND

• 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;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.

  PMID: 26264829 BACKGROUND

• Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. Eplasty. 2010 Jun 21;10:e43.

  PMID: 20596233 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Wound Infection

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Infections

Study Officials

• Finn F Lauszus, PhD

  Herning Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Women are randomized to either robotic single site or multi site hysterectomy

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: September 7, 2018
• Study Start: October 15, 2024
• Primary Completion: October 16, 2024
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

DK (1)