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Hypothesis:
In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one and a half times higher in men than in women. The average age of diagnosis is 65. Unlike colon cancer, technical management remains challenging with unresolved operating difficulties. Morbidity of surgical procedures remains high with a very large number of preventive or curative stoma derivations.
Reference in surgical treatment is total excision of the rectum and its mesentery, followed by continuity restoration by immediate coloanal anastomosis (ACAI). In this procedure, rate of fistula that results is reported in the literature between 15 and 25%.
An alternative to ACAI is delayed coloanal anastomosis without reservoir (ACAD). Based on retrospective experiences, we form the hypothesis that ACAD offers a much lower rate of fistula (<5%) and allows diminution of preventive stoma derivation practice. Morbidity and mortality are reduced, and patient's quality of life greatly improved. Direct costs (consumables intraoperative, hospitalization, stoma complications) and indirect (pocket-fitting stoma) are greatly reduced.
This study is a multicentre, two arms, phase 2 clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) | Experimental | Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. |
|
| Colo-anal anastomosis (CAA) | Experimental | Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) | Procedure | 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation |
| Measure | Description | Time Frame |
|---|---|---|
| Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA | Efficacy of the intervention was defined as the absence at day 30 of a symptomatic AL (either with entero-cutaneous fistula or perianastomotic abscess with infectious conditions and/or transit impairment) requiring diverting stoma (curatively for 2-stage CA or prophylactic-based for CA). AL was defined as fecal matter in the drainage system when a drainage system was present. Clinical signs included fever and subocclusion requiring a pelvic scan and collection of liquid and gas in the peri-anastomotic region. Non-symptomatic ALs which did not require any investigation nor treatment, in particular no diverting stoma, were not considered failures. Assuming an efficacy rates of 85% (null hypothesis) and 95% (alternative hypothesis), and relied on a superiority test at the 5% significance level (one-sided) with 80% power, 53 eligible and assessable patients were required. Efficacy of the intervention was concluded if at least 49 patients had no symptomatic AL at day 30. | Delayed coloanal anastomosis effectiveness was evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation. |
| Measure | Description | Time Frame |
|---|---|---|
| Stomata Bypass (Preventive or Therapeutic) | Number of patients with stomata bypass (preventive or therapeutic) at each time of follow-up after surgery (2SCA or CAA). A stomata bypass is the result of a surgical operation in which a damaged part is removed from the ileum (ileostomy) or colon (colostomy) and the cut end diverted to an artificial opening in the abdominal wall. | Presence of stomata bypass was evaluated at 30 days, 1 year and 2 years after surgery (2SCA or CAA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| EVRARD Serge, PU-PH | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU DE BORDEAUX - Hôpital Saint André | Bordeaux | Aquitaine | 33000 | France | ||
| Institut Bergonié |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37949519 | Background | Evrard S, Bellera C, Desolneux G, Cantarel C, Toulza E, Faucheron JL, Rivoire M, Dupre A, Mabrut JY, Bresler L, Marchal F, Bouriez D, Rullier E. Anastomotic leakage and functional outcomes following total mesorectal excision with delayed and immediate colo-anal anastomosis for rectal cancer: Two single-arm phase II trials. Eur J Surg Oncol. 2023 Nov;49(11):107015. doi: 10.1016/j.ejso.2023.107015. Epub 2023 Oct 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) | Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2016 |
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Two multicenter parallel single-arm phase II trials.
One trial assessing 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention.
One trial assessing colo-anal anastomosis (CAA) in centers who routinely performing this intervention.
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|
| Colo-anal anastomosis (CAA) | Procedure | After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch |
|
| Post-operative Morbidity | Post-operative morbidity was assessed in terms number of patients with at least one surgical complications related to treatment and related to a serious adverse event. | During the 30 first days after surgery (2SCA or CAA) |
| Postoperative Mortality | Postoperative mortality was defined by the number of patients who deceased (all cause mortality) during the first 30 days after surgery (2SCA or CAA). | From the date of surgery to 30 days after surgery (2SCA or CAA) |
| Progression-free Survival | Progression-free survival (PFS) was defined as the time from the date of surgery and the date of the earliest of the following events:
Progression was defined as clinical or radioglogical progression. Radiological progression was defined Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions" 1-year and 2-year progression-free rates were estimated. | 1 and 2 years after surgery (2SCA or CAA) |
| Number of Participants With Anal Incontinence at 6 Months | The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20). The rate of patients with anal incontinence (score >=5) at 6 months was reported. | At 6 months after surgery (2SCA or CAA) |
| Number of Participants With Anal Incontinence at 12 Months | The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20). The rate of patients with anal incontinence (score >=5) at 12 months was reported. | At 12 months after surgery (2SCA or CAA) |
| Number of Participants With Anal Incontinence at 24 Months | The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20). The rate of patients with anal incontinence (score >=5) at 24 months was reported. | At 24 months after surgery (2SCA or CAA) |
| Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among CAA | Efficacy of the intervention was defined as the absence at day 30 of a symptomatic AL (either with entero-cutaneous fistula or perianastomotic abscess with infectious conditions and/or transit impairment) requiring diverting stoma. AL was defined as fecal matter in the drainage system when a drainage system was present. Clinical signs included fever and subocclusion requiring a pelvic scan and collection of liquid and gas in the peri-anastomotic region. Non-symptomatic ALs which did not require any investigation nor treatment, in particular no diverting stoma, were not considered failures. The effectiveness of the CAA surgery will be evaluated in terms of absence of fistula requiring stoma diversion. Similarly to 2SCA group, 53 CAA eligible and evaluable patients will be required. If 49 or more patients (out of 53) have no fistula requiring stoma diversion, then we conclude that the CAA is effective. To anticipate any non evaluable patients, we plan to recruit 58 patients CAA. | Colo-anal anastomosis effectiveness will be evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation. |
| Bordeaux |
| Aquitaine |
| 33000 |
| France |
| CHU de GRENOBLE | Grenoble | Auvergne-Rhône-Alpes | 38000 | France |
| Centre Léon Bérard | Lyon | Auvergne-Rhône-Alpes | 69000 | France |
| HOSPICES CIVILS DE LYON - Hôpital de la Croix Rousse | Lyon | Auvergne-Rhône-Alpes | 69000 | France |
| Clinique Du Tonkin | Villeurbanne | Auvergne-Rhône-Alpes | 69000 | France |
| Institut Paoli Calmettes | Marseille | Bouche Du Rhône | 13000 | France |
| Chu de Nancy | Nancy | Lorraine | 54000 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | Lorraine | 54000 | France |
| FG001 | Colo-anal Anastomosis (CAA) | Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Eligible patient (without major protocole deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) | Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation |
| BG001 | Colo-anal Anastomosis (CAA) | Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among 2SCA | Efficacy of the intervention was defined as the absence at day 30 of a symptomatic AL (either with entero-cutaneous fistula or perianastomotic abscess with infectious conditions and/or transit impairment) requiring diverting stoma (curatively for 2-stage CA or prophylactic-based for CA). AL was defined as fecal matter in the drainage system when a drainage system was present. Clinical signs included fever and subocclusion requiring a pelvic scan and collection of liquid and gas in the peri-anastomotic region. Non-symptomatic ALs which did not require any investigation nor treatment, in particular no diverting stoma, were not considered failures. Assuming an efficacy rates of 85% (null hypothesis) and 95% (alternative hypothesis), and relied on a superiority test at the 5% significance level (one-sided) with 80% power, 53 eligible and assessable patients were required. Efficacy of the intervention was concluded if at least 49 patients had no symptomatic AL at day 30. | Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure. | Posted | Count of Participants | Participants | Delayed coloanal anastomosis effectiveness was evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Stomata Bypass (Preventive or Therapeutic) | Number of patients with stomata bypass (preventive or therapeutic) at each time of follow-up after surgery (2SCA or CAA). A stomata bypass is the result of a surgical operation in which a damaged part is removed from the ileum (ileostomy) or colon (colostomy) and the cut end diverted to an artificial opening in the abdominal wall. | Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively. | Posted | Count of Participants | Participants | Presence of stomata bypass was evaluated at 30 days, 1 year and 2 years after surgery (2SCA or CAA) |
| ||||||||||||||||||||||||||||
| Secondary | Post-operative Morbidity | Post-operative morbidity was assessed in terms number of patients with at least one surgical complications related to treatment and related to a serious adverse event. | Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively. | Posted | Count of Participants | Participants | During the 30 first days after surgery (2SCA or CAA) |
| ||||||||||||||||||||||||||||
| Secondary | Postoperative Mortality | Postoperative mortality was defined by the number of patients who deceased (all cause mortality) during the first 30 days after surgery (2SCA or CAA). | Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively. | Posted | Count of Participants | Participants | From the date of surgery to 30 days after surgery (2SCA or CAA) |
| ||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival (PFS) was defined as the time from the date of surgery and the date of the earliest of the following events:
Progression was defined as clinical or radioglogical progression. Radiological progression was defined Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions" 1-year and 2-year progression-free rates were estimated. | Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively. | Posted | Number | 95% Confidence Interval | percentage or paticipants | 1 and 2 years after surgery (2SCA or CAA) |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Anal Incontinence at 6 Months | The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20). The rate of patients with anal incontinence (score >=5) at 6 months was reported. | Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively and who responded to the questionnaire. | Posted | Count of Participants | Participants | At 6 months after surgery (2SCA or CAA) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anal Incontinence at 12 Months | The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20). The rate of patients with anal incontinence (score >=5) at 12 months was reported. | Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively and who responded to the questionnaire. | Posted | Count of Participants | Participants | At 12 months after surgery (2SCA or CAA) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anal Incontinence at 24 Months | The digestive functions, especially anal incontinence was evaluated according to the scale of 5 items Jorge and Wexner (score from 0 to 20). The rate of patients with anal incontinence (score >=5) at 24 months was reported. | Eligible patient (without major protocol deviation) which was operated with complete 2SCA procedure and CAA for 2SCA group and CAA group respectively and who responded to the questionnaire. | Posted | Count of Participants | Participants | At 24 months after surgery (2SCA or CAA) |
| ||||||||||||||||||||||||||||
| Secondary | Absence at Day 30 of a Symptomatic Anastomotic Leakage (AL) Among CAA | Efficacy of the intervention was defined as the absence at day 30 of a symptomatic AL (either with entero-cutaneous fistula or perianastomotic abscess with infectious conditions and/or transit impairment) requiring diverting stoma. AL was defined as fecal matter in the drainage system when a drainage system was present. Clinical signs included fever and subocclusion requiring a pelvic scan and collection of liquid and gas in the peri-anastomotic region. Non-symptomatic ALs which did not require any investigation nor treatment, in particular no diverting stoma, were not considered failures. The effectiveness of the CAA surgery will be evaluated in terms of absence of fistula requiring stoma diversion. Similarly to 2SCA group, 53 CAA eligible and evaluable patients will be required. If 49 or more patients (out of 53) have no fistula requiring stoma diversion, then we conclude that the CAA is effective. To anticipate any non evaluable patients, we plan to recruit 58 patients CAA. | Eligible patient (without major protocol deviation) which was operated with complete CAA procedure. | Posted | Count of Participants | Participants | Colo-anal anastomosis effectiveness will be evaluated in terms of symptomatic anastomotic fistula occurring during the 30 days post anastomosis and requiring stoma derivation. |
|
From dated written informed consents, up to 30 days following last follow-up, with an average of 24 months.
Only Serious Adverse events were collected following NCI-CTCAE (3.0).
Other [Not Including Serious] Adverse Events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2-stage Pull-through Colo-anal Anastomosis Without Prophylactic Derivation (2SCA) | Patients treated with 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) in centers who routinely performing this intervention. 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA): 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy. After surgical resection, the colon is exteriorized through the anus and attached to the buttock. By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation | 4 | 48 | 30 | 48 | 0 | 0 |
| EG001 | Colo-anal Anastomosis (CAA) | Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch | 0 | 52 | 24 | 52 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | CARDIAC GENERAL |
|
| ALTERED GENERAL CONDITION | General disorders | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| ABDOMINO PERINEAL AMPUTATION FOR RECURRENCE OF RECTAL ADENOCARCINOMA | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| MANAGEMENT OF HEPATIC METASTASES OF THE ANTERIOR BORDER OF SEGMENT VII | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| LEFT COLON LUMPECTOMY | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| Hepatic metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| DISEASE PROGRESSION | General disorders | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| METACHRONOUS LIVER METASTASES OF RECTAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| Metastatic recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| ANASTOMOTIC RECURRENCE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| LOCAL AND METASTATIC RECURRENCE (LUNGS) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| HEPATIC EVOLUTIONARY RECOVERY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| PELVIC TUMOR RECURRENCE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | CONSTITUTIONAL SYMPTOMS |
|
| PERISTOMAL DERMATITIS ASSOCIATED WITH SKIN ULCERATION | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | DERMATOLOGY/SKIN |
|
| Ascites (non-malignant) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL |
|
| Fistula, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL |
|
| Anitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL |
|
| RECTAL RESECTION SYNDROME | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL |
|
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL |
|
| Incontinence, anal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL |
|
| Necrosis, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL |
|
| Obstruction, GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL |
|
| Stricture/stenosis (including anastomotic), GI | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | GASTROINTESTINAL |
|
| Hematoma | Vascular disorders | CTCAE (3.0) | Systematic Assessment | HEMORRHAGE/BLEEDING |
|
| Hemorrhage/bleeding associated with surgery, intra-operative or postoperative | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment | HEMORRHAGE/BLEEDING |
|
| Infection with unknown ANC | Infections and infestations | CTCAE (3.0) | Systematic Assessment | INFECTION |
|
| CNS cerebrovascular ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | NEUROLOGY |
|
| Cognitive disturbance | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment | NEUROLOGY |
|
| Psychosis (hallucinations/delusions) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment | NEUROLOGY |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment | PAIN |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | PULMONARY/UPPER RESPIRATORY |
|
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | PULMONARY/UPPER RESPIRATORY |
|
| Stricture/stenosis (including anastomotic), GU | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | RENAL/GENITOURINARY |
|
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | RENAL/GENITOURINARY |
|
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment | SEXUAL/REPRODUCTIVE FUNCTION |
|
| EVENTRATION | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment | SURGERY/INTRA-OPERATIVE INJURY |
|
| BILATERAL INGUINAL HERNIA | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment | SURGERY/INTRA-OPERATIVE INJURY |
|
| STOMAL PROLAPSE | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment | SURGERY/INTRA-OPERATIVE INJURY |
|
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment | VASCULAR |
|
| Visceral arterial ischemia (non-myocardial) | Vascular disorders | CTCAE (3.0) | Systematic Assessment | VASCULAR |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Simone Mathoulin-Pelissier | Institut Bergonié | 0556333333 | S.Mathoulin@bordeaux.unicancer.fr |
| Jul 12, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
|
|
|
Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch |
|
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| OG001 | Colo-anal Anastomosis (CAA) | Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention. Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often. In the absence of fistula, the patient will reoperation for stoma closure of its branch |
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Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.
Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.
In the absence of fistula, the patient will reoperation for stoma closure of its branch
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Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.
Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.
In the absence of fistula, the patient will reoperation for stoma closure of its branch
|
|
Patients operated with colo-anal anastomosis (CAA) in centers who routinely performing this intervention.
Colo-anal anastomosis (CAA): After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.
In the absence of fistula, the patient will reoperation for stoma closure of its branch
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