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

NCT04013347 | Completed

• 1 other identifier: 08/17 OSS ComEt CBM
• Study Type: observational
• Target: 167
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Neoadjuvant Chemoradiotherapy; Rectal Tumor; Surgery; Surgery--Complications

Outcome Measures

Primary Outcomes (2)

• number of patient with low tumor regression grade

  rate of low tumor regression grade (1-2)

  1 week after surgery

• number of patient with surgical complications

  rate of surgical complications

  1 month after surgery

Secondary Outcomes (1)

• number of patient with anastomotic dehiscence

  1 month after surgery

Study Arms (3)

Early Surgery

Surgery after ≤ 42 days from the end of neoadjuvant radio-chemotherapy

Procedure: Rectal Resection

Late Surgery

Surgery after 43-56 days from the end of neoadjuvant radio-chemotherapy

Procedure: Rectal Resection

Very Late Surgery

Surgery after 57 or more days from the end of neoadjuvant radio-chemotherapy

Procedure: Rectal Resection

Interventions

Rectal Resection PROCEDURE

Low Anterior Resection and Abdominoperineal Resection

Early Surgery; Late Surgery; Very Late Surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

One hundred and sixty-seven patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015 were retrospectively analysed.

You may qualify if:

• \- 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.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Related Publications (1)

• Caputo D, Angeletti S, Fiore M, Ciccozzi M, Coppola A, Cartillone M, La Vaccara V, Spagnolo G, Trodella L, Coppola R. Delayed surgery after radio-chemotherapy for rectal adenocarcinoma is protective for anastomotic dehiscence: a single-center observational retrospective cohort study. Updates Surg. 2020 Jun;72(2):469-475. doi: 10.1007/s13304-020-00770-1. Epub 2020 Apr 18.

  PMID: 32306273 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Proctectomy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 9, 2019
• Study Start: January 1, 2005
• Primary Completion: March 1, 2015
• Study Completion: March 21, 2017
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share