An observational study in Colonic Neoplasms and Colonic Diverticulosis, sponsored by Groupe Hospitalier de la Rochelle Ré Aunis. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Groupe Hospitalier de la Rochelle Ré Aunis · Observational
Among 213 studies in Colonic Neoplasms with a site in France — 49 open to participants now, 66 under way, 13 of them phase 3. Colonic Neoplasms · France.
Among the 213 studies in Colonic Neoplasms with a site in France, this one is the 50th largest by enrollment of the 55 observational ones that give a count, is one of 11 that started in 2020, is one of 55 observational ones, and was the 140th registered.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
Browse Colonic Neoplasms studies →49 of the 213 studies in Colonic Neoplasms with a site in France are open now. Recruiting first, the newest first:
Gustave Roussy, Cancer Campus, Grand Paris · Sites in France
Ages 18+
Incyte Corporation · Sites in France, United States, Argentina and 19 more countries
Ages 18+
University Hospital, Clermont-Ferrand · Sites in France
Ages 18+
Pfizer · Sites in France, United States, Spain
Ages 18+
Pfizer · Sites in France, United States, Argentina and 14 more countries
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 326 Colonic Neoplasms studies recruiting now, 203 (62%) set no upper age limit and 71 (22%) stop at 75 or younger; 19 take children under 18; 34 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
213 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 56 · Phase 3 44 · Phase 4 3
First in 1990; this study’s year is marked. 11 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 227 across 555 observational studies indexed under Colonic Neoplasms.
Median enrollment 186 across the 143 interventional studies, 220 across the 55 observational. Of the 106 that completed or were terminated, 20 (19%) have results posted.
This tab as a report to print or save as PDF → With an account.
45 of 213 have an industry lead sponsor. The 10 most frequent:
Groupe Hospitalier de la Rochelle Ré Aunis is the lead sponsor of 22 studies on the registry; 6 are open to participants now.
Groupe Hospitalier de la Rochelle Ré Aunis has 1 study filed under Colonic Neoplasms — fewer than ten, so there is no comparison to draw.
10 of the studies in Colonic Neoplasms with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07000474University Hospital, BrestMultiparametric Characterization of Colorectal Cancers (METRAD) | 2026-12-31 |
| NCT05433142Xencor, Inc.Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma | 2027-02 |
| NCT05577143University Hospital, LilleBlood Screening for Adult Colorectal Cancer | 2027-03 |
| NCT05462717Revolution Medicines, Inc.Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors | 2027-03-31 |
| NCT06287814University Hospital, MontpellierFrench Assessment of MRD by Liquid Biopsies in Stage III CRC Patients (FRENCH.MRD.CRC) | 2027-04-11 |
Among the 213 studies in Colonic Neoplasms with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The success of the enhanced recovery program after surgery leads us to consider outpatient management of the colectomy. To this end, the investigators have designed an observational and prospective study of left laparoscopic colectomy on an outpatient basis. The objective is to assess the harmlessness of this management compared to standard management in the context of a public hospital.
In France, colectomy represents about 40,000 interventions per year, most of them scheduled, and 2/3 in a context of neoplasia. This surgery is associated with numerous postoperative complications. Since the start of Enhanced Recovery After Surgery (ERAS) in 1997, complications have been steadily reduced by optimizing surgical and anaesthetic techniques. At the same time, the average length of post-operative stay has decreased. In 2014, ERAS was the subject of recommendations by the French Society of Anaesthesia and Resuscitation, taken up by the French Health Authority (HAS) in 2016, and which are now an integral part of surgical management in colorectal surgery. More recently, two teams have set up an outpatient colectomy program. The three studies published on this subject show encouraging results, in a private structure, with no increase in postoperative complications.
In accordance with the recommendations on ERAS published by the HAS, a program involving pre-, per- and post-interventional investment, has been put in place. Patients are discharged on D0, followed by close monitoring by a home care nurse twice daily. This nurse is in charge of collecting clinical data in order to detect possible early signs of post-operative complications that would justify re-hospitalisation after a medical-surgical decision.
Patients taken care for a left colectomy due to colonic neoplasm or diverticulosis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Left laparoscopic laparoscopic colectomy patient managed on an outpatient basis
Procedure: Colectomy
colectomy due to neoplastic (stage 1) or diverticulosis
30-day readmission rate
Number of re-hospitalisation after a medical-surgical decision due to post-operative complications
Time frame: 30 days after surgery
Pain measurement: pain rating scale
Score at the numerical pain rating scale
Time frame: 7 days after surgery
Mobilization
Time (in hours) between extubation and first mobilization
Time frame: Day 0
Ileus
Number of day between surgery and first gas / stool
Time frame: up to 7 days after surgery
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2020 to primary completion in Nov 2022, 23 months.
Of 186 non-industry observational studies under Colonic Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 116. This study's 23 months is below that.
Counting every sponsor, half of 224 studies reached it within 50 months; a quarter within 24 and three quarters within 116.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier de la Rochelle Ré Aunis