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

Ovarian Cancer Clinical Trial

— ROBO-GYN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247779
• Other study ID #: ROBOGYN - 1004
• Secondary ID: 2010-A00605-34
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: November 2017

Study information

• Verified date: March 2019
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: November 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• metastatic disease

• pregnant or breastfeeding woman

• patient unable to proceed follow-up visit, because of geographic, social or mental reasons

Related Conditions & MeSH terms

• Cervical Cancer
• Ovarian Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms
• Uterus Cancer

Intervention

Procedure:
• gynecologic surgery - standard coelioscopy
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy
• gynecologic surgery - robot assisted coelioscopy
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

Locations

Country	Name	City	State
France	CHU Bordeaux, Hôpital Saint-André	Bordeaux
France	Polyclinique Bordeaux Nord Aquitaine	Bordeaux
France	Centre Oscar Lambret	Lille
France	CHRU Lille, Hôpital Jeanne de Flandres	Lille
France	CHU Limoges	Limoges
France	Institut Paoli Calmette	Marseille
France	CHU Nîmes	Nimes
France	Polyclinique KenVal	Nimes
France	Hôpital Européen Georges Pompidou	Paris
France	Polyclinique Courlancy	Reims
France	Centre hospitalier de Roubaix	Roubaix
France	Institut de Cancérologie de l'Ouest Site René Gauducheau	St HERBLAIN
France	CHU Rangueil	Toulouse
France	Institut Claudius Regaud	Toulouse
France	CHRU de Tours	Tours
France	Centre Hospitalier de Valenciennes	Valenciennes
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Centre Oscar Lambret	CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	six months after surgery
Secondary	Anesthesic and ventilator parameters	Description of anesthesic and ventilator parameters	every 30 min during the surgery
Secondary	Post-operative analgesia	collect of antalgic treatments	at 24h, 48h after sugery and until discharge
Secondary	Surgeon's ergonomy	according to Borg and NASA-TLX scales	every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale)
Secondary	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.	until 2 years after surgery
Secondary	Description of surgical procedures	operative time (overall intervention, incision or "skin-to-skin", robot).	during surgery
Secondary	Progression-free survival	delay between the date of randomization and the date of the following event: local relapse, regional relapse, metastasis or death.	until 2 years after surgery
Secondary	Anatomopathology	rate of exeresis with histologically healthy resection margins (R0), number of lymph nodes removed.	during surgery