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This study aimed to compare the outcomes of early versus late surgical resection in patients who underwent curative total mesorectal excision after neoadjuvant chemoradiation. Half of the participants will undergo surgery before 8 weeks, while the other half will undergo surgery after 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early surgery group | Experimental | İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy. |
|
| Late surgery group | Experimental | İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total mesorectal excision before 56 days (4-8 weeks) | Procedure | Low anterior resection or abdominoperineal resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response Rate | Complete pathological response, defined as the absence of viable tumor cells, may develop after neoadjuvant treatment for rectal cancer. Prognostic factors affecting pathological complete response will be evaluated. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Completeness of the Mesorectal Dissection | Examination will be made in a fresh state for completeness of the mesorectal dissection and will be graded according to the criteria of Quirke as follows: Low: (Grade 1) Little bulk of the mesorectum with defects down into the muscularis propria and/or very irregular circumferential resection margin. Moderate: (Grade 2) Moderate bulk of the mesorectum but there is irregularity in the mesorectal surface. Moderate coning of the specimen toward the distal margin. At no site is the muscularis propria visible with exception of the insertion of the levator muscles. Moderate irregularity of the circumferential resection margin. High: (Grade 3) Intact mesorectum with smooth mesorectal surface. No defect deeper than 5 mm. No coning on the specimen. Smooth circumferential resection margins on slicing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Z.Erhan Akgun, Proffesor | Ege University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36254732 | Derived | Akgun E, Caliskan C, Bozbiyik O, Yoldas T, Doganavsargil B, Ozkok S, Kose T, Karabulut B, Elmas N, Ozutemiz O. Effect of interval between neoadjuvant chemoradiotherapy and surgery on disease recurrence and survival in rectal cancer: long-term results of a randomized clinical trial. BJS Open. 2022 Sep 2;6(5):zrac107. doi: 10.1093/bjsopen/zrac107. | |
| 30155949 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Classic Interval Group | İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy. Total mesorectal excision before 56 days (4-8 weeks): Low anterior resection or abdominoperineal resection |
| FG001 | Long Interval Group | İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy. Total mesorectal excision after 56 days (8-12 weeks): Low anterior resection or abdominoperineal resection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
350 patients were randomly assigned. After perioperative evaluation of 350 patients who underwent CRT , 15 patients in the CI group (no surgery, 5; R2 resection, 5; stage IV disease, 2; lost to follow-up, 3) and eight in the LI group (no surgery, 4; R2 resection, 2; stage IV disease, 2) were excluded from the study. 327 included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Classic Interval Group | İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy. Total mesorectal excision before 56 days (4-8 weeks): Low anterior resection or abdominoperineal resection |
| BG001 | Long Interval Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathological Complete Response Rate | Complete pathological response, defined as the absence of viable tumor cells, may develop after neoadjuvant treatment for rectal cancer. Prognostic factors affecting pathological complete response will be evaluated. | Posted | Count of Participants | Participants | 2 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Classic Interval Group | İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy. Total mesorectal excision before 56 days (4-8 weeks): Low anterior resection or abdominoperineal resection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anastomotic leakage | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erhan Akgun,MD, Proffessor | Ege University Hospital | +902323905050 | z.erhan.akgun@ege.edu.tr |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Total mesorectal excision after 56 days (8-12 weeks) | Procedure | Low anterior resection or abdominoperineal resection |
|
| 30 days after surgery |
| Tumour Regression Grade | All pathological examinations were undertaken by two experienced gastrointestinal pathologists. Pathological treatment response to neoadjuvant chemoradiotherapy was evaluated by a five-tiered system described by Mandard. Tumor regression grade groups were identified as: Grade 1: the absence of residual cancer Grade 2: the presence of residual cancer cells scattered throughout the fibrosis Grade 3: an increase in the number of residual cancer cells but fibrosis still predominant Grade 4: residual cancer outgrowing fibrosis Grade 5, the absence of regressive changes Grade 1 considered as complete response. Grade 2-4 considered as partial response and Grade 5 considered as no response. | 30 days after surgery |
| Surgical Complications | Morbidity will be assessed according to the classification of Clavien-Dindo as follows: Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside Grade 2: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade 3: Requiring surgical, endoscopic or radiological intervention (Grade 3a: Intervention not under general anesthesia, Grade 3b: Intervention under general anesthesia) Grade 4: Life-threatening complication requiring Intensive Care Unit management (Grade 4a: Single organ dysfunction (including dialysis), Grade 4b: Multiorgan dysfunction) Grade 5 Death | 90 days after surgery |
| Recurrence | Both pelvic recurrence and distant metastasis will be assessed. | 5 years after surgery |
| Disease-free Survival | Recurrence free survival | 5 years after surgery |
| Overall Survival | Total survival with or without disease | 5 years after surgery |
| Akgun E, Caliskan C, Bozbiyik O, Yoldas T, Sezak M, Ozkok S, Kose T, Karabulut B, Harman M, Ozutemiz O. Randomized clinical trial of short or long interval between neoadjuvant chemoradiotherapy and surgery for rectal cancer. Br J Surg. 2018 Oct;105(11):1417-1425. doi: 10.1002/bjs.10984. Epub 2018 Aug 29. |
İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy. Total mesorectal excision after 56 days (8-12 weeks): Low anterior resection or abdominoperineal resection |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Completeness of the Mesorectal Dissection | Examination will be made in a fresh state for completeness of the mesorectal dissection and will be graded according to the criteria of Quirke as follows: Low: (Grade 1) Little bulk of the mesorectum with defects down into the muscularis propria and/or very irregular circumferential resection margin. Moderate: (Grade 2) Moderate bulk of the mesorectum but there is irregularity in the mesorectal surface. Moderate coning of the specimen toward the distal margin. At no site is the muscularis propria visible with exception of the insertion of the levator muscles. Moderate irregularity of the circumferential resection margin. High: (Grade 3) Intact mesorectum with smooth mesorectal surface. No defect deeper than 5 mm. No coning on the specimen. Smooth circumferential resection margins on slicing. | Posted | Count of Participants | Participants | 30 days after surgery |
|
|
|
| Secondary | Tumour Regression Grade | All pathological examinations were undertaken by two experienced gastrointestinal pathologists. Pathological treatment response to neoadjuvant chemoradiotherapy was evaluated by a five-tiered system described by Mandard. Tumor regression grade groups were identified as: Grade 1: the absence of residual cancer Grade 2: the presence of residual cancer cells scattered throughout the fibrosis Grade 3: an increase in the number of residual cancer cells but fibrosis still predominant Grade 4: residual cancer outgrowing fibrosis Grade 5, the absence of regressive changes Grade 1 considered as complete response. Grade 2-4 considered as partial response and Grade 5 considered as no response. | Posted | Count of Participants | Participants | 30 days after surgery |
|
|
|
| Secondary | Surgical Complications | Morbidity will be assessed according to the classification of Clavien-Dindo as follows: Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside Grade 2: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade 3: Requiring surgical, endoscopic or radiological intervention (Grade 3a: Intervention not under general anesthesia, Grade 3b: Intervention under general anesthesia) Grade 4: Life-threatening complication requiring Intensive Care Unit management (Grade 4a: Single organ dysfunction (including dialysis), Grade 4b: Multiorgan dysfunction) Grade 5 Death | Posted | Count of Participants | Participants | 90 days after surgery |
|
|
|
| Secondary | Recurrence | Both pelvic recurrence and distant metastasis will be assessed. | Not Posted | 5 years after surgery | Participants |
| Secondary | Disease-free Survival | Recurrence free survival | Not Posted | 5 years after surgery | Participants |
| Secondary | Overall Survival | Total survival with or without disease | Not Posted | 5 years after surgery | Participants |
| 1 |
| 160 |
| 36 |
| 160 |
| 0 |
| 160 |
| EG001 | Long Interval Group | İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy. Total mesorectal excision after 56 days (8-12 weeks): Low anterior resection or abdominoperineal resection | 4 | 167 | 33 | 167 | 0 | 167 |
| Wound infection | Surgical and medical procedures |
|
| Urinary leakage | Renal and urinary disorders |
|
| Pelvic abscess | Infections and infestations |
|
| Postoperative bleeding | Surgical and medical procedures |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Urinary tract infectio | Renal and urinary disorders |
|
| Prerenal insufficiency | Renal and urinary disorders |
|
| Mechanical bowel obstruction | Gastrointestinal disorders |
|
| Deep vein thrombosis, pulmonary embolism | Vascular disorders |
|
| Other | Surgical and medical procedures |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| High |
|
| Mandard Grade 3 |
|
| Mandard Grade 4 |
|
| Mandard Grade 5 |
|
| Clavien Dindo 3a |
|
| Clavien Dindo 3b |
|
| Clavien Dindo 4a |
|
| Clavien Dindo 4b |
|
| Clavien Dindo 5 |
|
| No complication |
|