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Completed

NCT Number: NCT01847703

Robotic Versus Abdominal Surgery for Endometrial Cancer

This study is intended to explore differences in oncologic and surgical safety between robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial cancer.

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Key information

Conditions

Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

About this study

Hypothesis: Robotic assisted laparoscopy (RAL)is equal in terms of oncologic and surgical safety as conventional abdominal surgery (AS) for high risk endometrial cancer (EC).

Methods: Women with high risk EC (defined as high grade endometrial, clear cell or serous) are randomized to either RAL or AS. Both groups will undergo complete surgical staging (hysterectomy, bilateral salpingoophorectomy, pelvic and paraaortal lymphadenectomy)

Primary endpoint: Number of harvested lymph nodes per station Secondary endpoints: Recurrences up to 3 year after surgery. Lymphatic side-effects, quality of life, cost, surgical morbidity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-75 years of age
  • High risk endometrial cancer

Exclusion criteria

  • WHO performance>1
  • Severe comorbidity, ASA>3
  • Unable to understand information

Treatment and study plan

Robotic surgery

Procedure

Minimal invasive surgery performed with daVinci robotic system

Abdominal surgery

Procedure

Current gold standard

Primary outcomes

  1. Number of harvested lymph nodes

    Time frame: 2 years

    Extracted lymphatic tissue from 3 stations (above inferior mesenteric artery, below inferior mesenteric artery, pelvic) is analysed by a pathologist and the number of nodes for each station recorded and compared between the two groups

Secondary outcomes

  1. Recurrence of cancer

    Time frame: 3 years

    Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site

  2. Lymphatic side-effects

    Time frame: 2 years

    Lymphatic side-effects will be monitored by repeated computed tomography (CT) 3 months and 12 months after surgery. Enrolled women will be asked specific, validated questions at follow-up

  3. Quality of life

    Time frame: 2 years

    All included participants will be asked to fill out a questionnaire (EORTC) to assess quality of life before and 1 year after surgery

  4. Healthcare cost

    Time frame: 2 years

    All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer

Acronym: RASHEC

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
May 7, 2013
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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