An interventional study of Tube drain insertion in Rectal Cancer, Rectal Neoplasms and Anastomotic Leak, sponsored by University of Rome Tor Vergata. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2017-10-30.
Sponsored by University of Rome Tor Vergata · Not applicable, Interventional, and Prevention
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Among 103 studies in Rectal Neoplasms with a site in Italy — 32 open to participants now, 41 under way, 3 of them phase 3. Rectal Neoplasms · Italy.
Among the 103 studies in Rectal Neoplasms with a site in Italy, this one is the 47th largest by planned enrollment of the 70 interventional ones that give a count, is one of 2 that started in 2017, is one of 25 with no phase, and was the 41st registered.
2,401 studies on the registry are indexed under Rectal Neoplasms; 588 are open to participants now.
Browse Rectal Neoplasms studies →32 of the 103 studies in Rectal Neoplasms with a site in Italy are open now. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Italy, United States, Canada and 6 more countries
Ages 18+
Gruppo Oncologico del Nord-Ovest · Sites in Italy, France, Germany and 1 more country
Ages 18+
Fondazione del Piemonte per l'Oncologia · Sites in Italy
Ages 18–75
National Cancer Institute, Naples · Sites in Italy
Ages 18+
Delcath Systems Inc. · Sites in Italy, United States, Czechia and 6 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 404 Rectal Neoplasms studies recruiting now, 210 (52%) set no upper age limit and 142 (35%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.
This study: 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.
103 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 8 · Phase 2 20 · Phase 3 21 · Phase 4 1
First in 1991; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 65 across 1,752 interventional studies indexed under Rectal Neoplasms.
Median enrollment 182 across the 70 interventional studies, 218 across the 30 observational. Of the 34 that completed or were terminated, 4 (12%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 103 have an industry lead sponsor. The 10 most frequent:
University of Rome Tor Vergata is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
University of Rome Tor Vergata has 3 studies filed under Rectal Neoplasms — fewer than ten, so there is no comparison to draw.
12 of the studies in Rectal Neoplasms with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06607458Delcath Systems Inc.Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease | 2026-12 |
| NCT05938322Fondazione Policlinico Universitario Agostino Gemelli IRCCSKetogenic Diet Compliance in Patients Undergoing Radiotherapy for Pelvic Cancers | 2026-12 |
| NCT04184973Colospan Ltd.Efficacy and Safety of the CG-100 Intraluminal Bypass Device | 2026-12-31 |
| NCT06952101Fondazione del Piemonte per l'OncologiaA Global, Integrated, Personalized, Stage-related, Multimodal Therapeutic Approach for Rectal Adenocarcinoma Based on Organ Sparing and Mininvasivity | 2026-12-31 |
| NCT04815694Fondazione Policlinico Universitario Agostino Gemelli IRCCSTHeragnostic Utilities for Neoplastic DisEases of the Rectum by MRI Guided Radiotherapy | 2027-01 |
Add all 12 to your calendar (.ics) → With an account.
Among the 103 studies in Rectal Neoplasms with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Anastomotic leakage (AL) is considered the commonest major complication after surgery for rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.
Patients who underwent low or ultralow anterior resection for rectal cancer were enrolled between 01/2015 and 06/2017. A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.
Patients were followed-up on the ward and then in the outpatient's department at two weeks, and one month postoperative. Patients who were suspected to have AL underwent CT with rectal contrast to assess the integrity of the anastomosis. The primary outcome was the incidence of AL. We adopted the definition published by the International Study Group of Rectal Cancer.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Tube drain insertion
A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.
Anastomotic leakage
Prevention
Time frame: 30 days
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2017; primary completion for Dec 2017, 2 months later.
Of 329 non-industry interventional studies with no phase under Rectal Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 78. This study's planned 2 months is below that.
Counting every sponsor, half of 336 studies reached it within 51 months; a quarter within 23 and three quarters within 78.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University of Rome Tor Vergata