Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study

Conditions

Effects of Chemotherapy, Peritoneal Cavity Cancer, Stage IV Ovarian Carcinoma

Keywords

Ovarian Cancer, Laparoscopy, Neoadjuvant Chemotherapy, Robotic, Interval Debulking Surgery

Brief summary

Phase II multicentric study

Detailed description

The aim of this prospective Phase II multicentric study is to assess feasibility and early complications rate of total laparoscopic/robotic interval debulking surgery in patients with a clinical complete/partial response to neoadjuvant chemotherapy for advanced ovarian cancer.

Jose Alejandro Rauh‐Hain, Alexander Melamed, René Pareja, Taymaa May, Abdulrahman Sinno et al. (14 authors)

JAMA Network Open2024-11-2111 citations

10.1001/jamanetworkopen.2024.46325

Feasibility of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III–IV ovarian cancer: the ULTRA-LAP trial pilot study

Roberto Tozzi, Marco Noventa, Carlo Saccardi, Giulia Spagnol, Orazio De Tommasi et al. (7 authors)

Journal of Gynecologic Oncology2023-10-197 citations

10.3802/jgo.2024.35.e14

Minimally invasive interval debulking surgery in ovarian neoplasm (MISSION trial-NCT02324595): a feasibility study.

Gueli Alletti S, Bottoni C, Fanfani F, Gallotta V, Chiantera V, Costantini B, Cosentino F, Cosentino F, Ercoli A, Scambia G, Fagotti A.

2015-10-3157 citations

10.1016/j.ajog.2015.10.922

Interventions

PROCEDURELaparoscopic interval debulking surgery

Diagnostic laparoscopy with a careful exploration of peritoneal cavity: if available a 5 mm flexible tip videolaparoscope will be used to explore all peritoneal recesses.For eligible patients,will be placed 3 5mm trocar in standard position for pelvic surgery:cytoreduction will consist in total/radical hysterectomy,bilateral salpingo-oophorectomy,radical omentectomy.If needed pelvic/upper peritonectomy will be performed:in these cases additional trocar can be placed in right or left subcostal spaces. All surgical procedure requested will have be carried out by laparoscopy/robotic or by laparotomy,in case of increased surgical risk or technical impossibility:the case will be registered as laparotomic conversion.At the end of surgical procedures residual tumor will be registered

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

No

Inclusion criteria

* Age \>18 years, * Advanced ovarian cancer submitted to neoadjuvant chemotherapy, * Clinical or serological complete/partial response (RECIST; GCIG), * PS ≤ 2 (ECOG), * Informed consent

Exclusion criteria

* Borderline and non-epithelial ovarian tumors, * Stable/progressive disease, * ASA 3-4, * Severe cardiopulmonary disease, * BMI \> 40

Design outcomes

Primary

Measure	Time frame	Description
Operative complication rate	30 days	Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery

Secondary

Measure	Time frame	Description
Progression Free survival	one year	time to recurrence
Overall Survival	One year	time to last follow up/death

Countries

Italy

Outcome results

None listed