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Outcomes of Resection at Different Times Between the End of Neoadjuvant Treatment and Surgery

Evaluation of Anatomopathological, Oncological and Surgical Outcomes in Relation to the Different Times Between the End of Neoadjuvant Treatment and Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04013347
Enrollment
167
Registered
2019-07-09
Start date
2005-01-01
Completion date
2017-03-21
Last updated
2019-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoadjuvant Chemoradiotherapy, Rectal Tumor, Surgery, Surgery--Complications

Brief summary

Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal tumours. Ideal time interval between the end of NRCT and surgery is still debated; a 6-8 weeks time interval is considered optimal, but shorter or longer intervals have been associated with better oncological outcomes. Moreover, there is a lack of data about clinical postoperative outcomes and different time intervals after the end of NRCT. Here, effect that different time intervals have on postoperative complications with particular regard to the anastomotic dehiscence have been evaluated. Methods One hundred-sixty-seven patients underwent surgery after long-course NRCT. Three different time intervals were considered: (0-42; 43-56; \>57 days).

Detailed description

Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal adenocarcinoma. Even though a 6-8 weeks' time interval after the end of NRCT and surgery is considered ideal, the optimal time for surgery is still controversial.

Interventions

Low Anterior Resection and Abdominoperineal Resection

Sponsors

Campus Bio-Medico University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

\- patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015. To evaluate the anastomotic dehiscence were excluded patients undergone to Abdomino-perineal resection (APR) and 4 patients for whom data were not available.

Design outcomes

Primary

MeasureTime frameDescription
number of patient with surgical complications1 month after surgeryrate of surgical complications
number of patient with low tumor regression grade1 week after surgeryrate of low tumor regression grade (1-2)

Secondary

MeasureTime frameDescription
number of patient with anastomotic dehiscence1 month after surgeryrate of anastomotic dehiscence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026