NCT04709055

Brief Summary

Incidence of digestive cancers increase and half of new cases will be people of 75 years or more in 2050. Surgery is one of the main treatment's strategy but post-operative morbi-mortality increases with age. Pre-operative Geriatric Assessment enable to identify frail or vulnerable patients at risk of post-operative complications. The coordinating team postulate that a geriatric and surgical co-management with a combination of several targeted geriatric interventions with usual post-operative care could improve the post-operative care and decrease the risk of morbi-mortality in older patients with digestive cancers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
630

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

January 14, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2024

Completed
Last Updated

January 19, 2021

Status Verified

September 1, 2020

Enrollment Period

3.6 years

First QC Date

October 28, 2020

Last Update Submit

January 15, 2021

Conditions

Digestive Cancer

Keywords

AgeGeriatric AssesmentCo-managementSurgeryDigestive Cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo

    at 30 days after surgery

Secondary Outcomes (25)

  • Percentage of patients with postoperative complications of each grade in the Clavien-Dindo

    at Day 14 and Day 30

  • Percentage of patients with each complication among a prespecified list of complication

    at Day 14 and Day 30

  • Social Status

    at Day 14 and Day 30 after surgery

  • Activities of Daily Living Scale

    at Day 14 and Day 30 after surgery

  • Instrumental Activities of Daily Living Scale

    at Day 14 and Day 30 after surgery

  • +20 more secondary outcomes

Study Arms (2)

Co-management arm (geriatric and surgical)

EXPERIMENTAL
Other: Co-management

Usual care

ACTIVE COMPARATOR
Other: Usual care

Interventions

Co-managementOTHER

Personalized and intensive geriatric peri-operative care

Co-management arm (geriatric and surgical)
Usual careOTHER

Pre-operative and post-operative geriatric care as per usual practice

Usual care

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged 75 years or more
  • Gastric, colo-rectal, pancreatic cancer or hepatic metastasis needed a surgical treatment
  • Health Insurance
  • At risk of post-operative complication through Surgical Risk Calculator (\>25%) or surgeon judgment.
  • Written consent

You may not qualify if:

  • Surgery in emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris - Hôpital européen Georges-Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Elena PAILLAUD LAURENT PUIG, MD, PhD

    Assistance Publique Hôpitaux de Paris (AP-HP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena PAILLAUD LAURENT PUIG, MD, PhD

CONTACT

(0)1 56 09 21 64elena.paillaud@aphp.fr

Frédérique PESCHAUD, MD, PhD

CONTACT

(0)1 49 09 53 35frederique.peschaud@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

January 14, 2021

Study Start

January 14, 2021

Primary Completion

August 14, 2024

Study Completion

October 14, 2024

Last Updated

January 19, 2021

Record last verified: 2020-09

Locations

FR(1)