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Outcomes of Resection at Different Times Between the End of Neoadjuvant Treatment and Surgery
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).
| Condition or disease | Intervention/treatment |
|---|---|
| Neoadjuvant Chemoradiotherapy Rectal Tumor Surgery Surgery--Complications | Procedure: Rectal Resection |
| Study Type : | Observational |
| Actual Enrollment : | 167 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Evaluation of Anatomopathological, Oncological and Surgical Outcomes in Relation to the Different Times Between the End of Neoadjuvant Treatment and Surgery |
| Actual Study Start Date : | January 1, 2005 |
| Actual Primary Completion Date : | March 1, 2015 |
| Actual Study Completion Date : | March 21, 2017 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Early Surgery
Surgery after ≤ 42 days from the end of neoadjuvant radio-chemotherapy
|
Procedure: Rectal Resection
Low Anterior Resection and Abdominoperineal Resection
|
|
Late Surgery
Surgery after 43-56 days from the end of neoadjuvant radio-chemotherapy
|
Procedure: Rectal Resection
Low Anterior Resection and Abdominoperineal Resection
|
|
Very Late Surgery
Surgery after 57 or more days from the end of neoadjuvant radio-chemotherapy
|
Procedure: Rectal Resection
Low Anterior Resection and Abdominoperineal Resection
|
- number of patient with low tumor regression grade [ Time Frame: 1 week after surgery ]rate of low tumor regression grade (1-2)
- number of patient with surgical complications [ Time Frame: 1 month after surgery ]rate of surgical complications
- number of patient with anastomotic dehiscence [ Time Frame: 1 month after surgery ]rate of anastomotic dehiscence
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
No Contacts or Locations Provided
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 28, 2019 | ||||
| First Posted Date | July 9, 2019 | ||||
| Last Update Posted Date | July 9, 2019 | ||||
| Actual Study Start Date | January 1, 2005 | ||||
| Actual Primary Completion Date | March 1, 2015 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
number of patient with anastomotic dehiscence [ Time Frame: 1 month after surgery ] rate of anastomotic dehiscence
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Outcomes of Resection at Different Times Between the End of Neoadjuvant Treatment and Surgery | ||||
| Official Title | Evaluation of Anatomopathological, Oncological and Surgical Outcomes in Relation to the Different Times Between the End of Neoadjuvant Treatment and Surgery | ||||
| 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). |
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| 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. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
|
||||
| Intervention | Procedure: Rectal Resection
Low Anterior Resection and Abdominoperineal Resection
|
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| Study Groups/Cohorts |
|
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| Publications * | 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
167 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | March 21, 2017 | ||||
| Actual Primary Completion Date | March 1, 2015 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
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. |
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| Sex/Gender |
|
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| Ages | 18 Years to 90 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04013347 | ||||
| Other Study ID Numbers | 08/17 OSS ComEt CBM | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Vincenzo La Vaccara, Campus Bio-Medico University | ||||
| Study Sponsor | Campus Bio-Medico University | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Campus Bio-Medico University | ||||
| Verification Date | July 2019 | ||||
