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Cervical CancerROBO-GYNNCT01247779

Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy

A study testing gynecologic surgery - standard coelioscopy and gynecologic surgery - robot assisted coelioscopy in people with Cervical Cancer and Uterus Cancer, run by Centre Oscar Lambret at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer, Uterus Cancer, Ovarian Cancer
What is being tested?
gynecologic surgery - standard coelioscopy and gynecologic surgery - robot assisted coelioscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
386 participants
Where
17 sitesFrance
Study dates
Dec 2010to Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patient with uterus cancer depending on hysterectomy ± pelvic lymphadenectomy or a restadification
  • patient with cervical cancer depending on enlarged colpo-hysterectomy ± pelvic lymphadenectomy or a surgery after concomitant radiochemotherapy, or lombo aortic lymphadenectomy for a locally advanced cancer, or a restadification
  • patient with cervical cancer depending on a restadification
  • patient aged over 18 years
  • previous antitumor treatment allowed but necessarily disrupted 20 days before inclusion
  • WHO score equal or inferior to 3
Show all 10Show fewer
  • cirrhosis-related Child-Pugh score under or equal to A7 are allowed
  • life expectancy equal or superior to 12 weeks
  • patient affiliated to health insurance
  • dated and signed informed consent

Who cannot join

  • metastatic disease
  • pregnant or breastfeeding woman
  • patient unable to proceed follow-up visit, because of geographic, social or mental reasons

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • CHU Bordeaux, Hôpital Saint-André

    Bordeaux, 33300

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Centre Oscar Lambret

    Lille, 59000

  • CHRU Lille, Hôpital Jeanne de Flandres

    Lille, 59037

  • CHU Limoges

    Limoges, 87042

  • Institut Paoli Calmette

    Marseille, 13009

  • CHU Nîmes

    Nîmes, 30029

  • Polyclinique KenVal

    Nîmes, 30900

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Polyclinique Courlancy

    Reims, 51100

  • Centre hospitalier de Roubaix

    Roubaix, 59056

  • Institut de Cancérologie de l'Ouest Site René Gauducheau

    Saint-Herblain, 44805

  • Institut Claudius Regaud

    Toulouse, 31052

  • CHU Rangueil

    Toulouse, 31059

  • CHRU de Tours

    Tours, 37044

  • Centre Hospitalier de Valenciennes

    Valenciennes, 59322

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

Official title: Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy

The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.

Read the detailed description

Laparoscopic surgery, also called minimally invasive surgery (MIS), is a surgical method less invasive than classical laparoscopic open procedure. Particularly, MIS is used for resection of some gynecological cancer such as endometrial cancer, cervical cancer or ovarian cancer. Several studies demonstrated that MIS induce less surgical complications (bleeding, infections, post-operative pains...), shorter hospitalization time, earlier recovery of activity and better quality of life than laparoscopic open procedure.

However, MIS is the selected method in only 9 to 25 % of gynecologic cancer surgery in France. This is likely due to the longer learning curve of MIS compared to laparoscopic open procedure.

In 2001 the FDA allowed the use of robot assisted laparoscopic surgery (RALS). This technique adds some advantage to laparoscopic surgery. Indeed, surgeon operates with better precision while seated comfortably at a computer console viewing a 3-D image of the surgical field. Moreover learning curve of RALS is shorter than MIS. Comparative studies between RALS and MIS demonstrate an equivalence of these techniques for operation length and bleeding. However for surgery linked complications and time for recovery of activity, RALS had better results than MIS.

Despite its expensive cost, RALS is now commonly used in North America (90% of prostatectomy and 40% of cancer linked hysterectomy). However RALS need to be evaluated in a randomized clinical trial before it's acceptation in gyneco-oncology in France.

Thus, the purpose of the ROBOGYN clinical trial is to compare clinical benefit of RALS and MIS in a randomized study for patients with cancer of cervix, uterus or ovary.

Being tested
gynecologic surgery - standard coelioscopy, gynecologic surgery - robot assisted coelioscopy
Keywords
gynecology, oncology, coelioscopy, robot, morbidity
Medical subject headings
Uterine Cervical Neoplasms, Uterine Neoplasms, Ovarian Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gynecologic surgery - standard coelioscopyProcedure or surgery

    lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

  • gynecologic surgery - robot assisted coelioscopyProcedure or surgery

    lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

Study groups in NCT01247779
Study groupRoleWhat they receive
Standard CoelioscopyActive comparatorgynecologic surgery - standard coelioscopy
Receives: Procedure: gynecologic surgery - standard coelioscopy
Robot-assisted coelioscopyExperimentalgynecologic surgery - robot assisted coelioscopy
Receives: Procedure: gynecologic surgery - robot assisted coelioscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perioperative morbidity at six months

    To estimate the rate of complications within the first six months after surgery, according to the Clavien-Dindo and NCI CTCAE-v4.0 grading scales

    Measured: six months after surgery

Secondary outcomes (7)

  1. Anesthesic and ventilator parameters

    Description of anesthesic and ventilator parameters

    Measured: every 30 min during the surgery

  2. Post-operative analgesia

    collect of antalgic treatments

    Measured: at 24h, 48h after sugery and until discharge

  3. Surgeon's ergonomy

    according to Borg and NASA-TLX scales

    Measured: every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale)

  4. Patient-reported survey of patient health

    36-item short form health Survey (SF36) : Scoring is a two-step process. First, numeric values of all items are recoded per the scoring key (for example, values are 0/100, or 0/25/50/75/100 depending the items). All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores: physical functioning, Role functioning/physical, Role functioning/emotional, Energy/fatigue, Emotional well-being, Social functioning, Pain, General health, Health change. Scale scores represent the average for all items in the scale that the respondent answered.

    Measured: until 2 years after surgery

  5. Description of surgical procedures

    operative time (overall intervention, incision or "skin-to-skin", robot).

    Measured: during surgery

  6. Progression-free survival

    delay between the date of randomization and the date of the following event: local relapse, regional relapse, metastasis or death.

    Measured: until 2 years after surgery

  7. Anatomopathology

    rate of exeresis with histologically healthy resection margins (R0), number of lymph nodes removed.

    Measured: during surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionMar 2016
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
386 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01247779
Sponsor's protocol ID
ROBOGYN - 1004
Other IDs
PHRC10-1908, 2010-A00605-34
Acronym
ROBO-GYN
Status last verified
Mar 2026
First submitted
19 Nov 2010
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Narducci F, Bogart E, Hebert T, Gauthier T, Collinet P, Classe JM, Lecuru F, Delest A, Motton S, Conri V, Ferrer C, Marchal F, Ferron G, Probst A, Thery J, Le Deley MC, Lefebvre D, Francon D, Leblanc E, Lambaudie E. Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: Results of the randomized ROBOGYN-1004 trial. Gynecol Oncol. 2020 Aug;158(2):382-389. doi: 10.1016/j.ygyno.2020.05.010. Epub 2020 May 25.

    PubMed 32467054

Questions about this trial

What is this clinical trial studying?

A study testing gynecologic surgery - standard coelioscopy and gynecologic surgery - robot assisted coelioscopy in people with Cervical Cancer and Uterus Cancer, run by Centre Oscar Lambret at 17 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perioperative morbidity at six months (time frame: six months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01247779, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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