TriangleNCT01344018 · OUTCOME
Perioperative Complications
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the date of surgery, up to 60 days following surgery
What was measured
Adverse events and side effects possibly related to surgery were assessed according to the Dindo's classification. This scales the observed side effects as Grade 0 No event Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III Requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complication (including CNS complications) requiring IC/ICU-management Grade V Death of a patient For each item, the frequency of the worst grade of the observed toxicity was tabulated by treatment group. The perioperative period commence at the time of surgery (at the time of the induction anaesthesia) to the complete closure of the wound.
Analysis population: all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation followed by surgery)
Groups in this outcome
Surgery Alone
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery
Preoperative Radiotherapy Followed by En-bloc Surgery
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
| Group | Source count |
|---|---|
| Surgery Alone | 128 |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 119 |
Reported measurements
Source class 1
Dindo scale Grade 0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 57 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 34 | Not reported | Not reported | Not reported | Not reported |
Dindo scale Grade 1-2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 57 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 58 | Not reported | Not reported | Not reported | Not reported |
Dindo scale Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 13 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 24 | Not reported | Not reported | Not reported | Not reported |
Dindo scale Grade 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 1 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 2 | Not reported | Not reported | Not reported | Not reported |
Dindo scale Grade 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Surgery Alone | 0 | Not reported | Not reported | Not reported | Not reported |
| Preoperative Radiotherapy Followed by En-bloc Surgery | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 34
- title
- Dindo scale Grade 0
- measurements
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 58
- title
- Dindo scale Grade 1-2
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 24
- title
- Dindo scale Grade 3
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Dindo scale Grade 4
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Dindo scale Grade 5
- denoms
- counts
- group Id
- OG000
- value
- 128
- group Id
- OG001
- value
- 119
- units
- Participants
- description
- Adverse events and side effects possibly related to surgery were assessed according to the Dindo's classification. This scales the observed side effects as Grade 0 No event Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Grade III Requiring surgical, endoscopic or radiological intervention Grade IV Life-threatening complication (including CNS complications) requiring IC/ICU-management Grade V Death of a patient For each item, the frequency of the worst grade of the observed toxicity was tabulated by treatment group. The perioperative period commence at the time of surgery (at the time of the induction anaesthesia) to the complete closure of the wound.
- groups
- description
- En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated. therapeutic conventional surgery
- id
- OG000
- title
- Surgery Alone
- description
- 3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions therapeutic conventional surgery 3-dimensional conformal radiation therapy
- id
- OG001
- title
- Preoperative Radiotherapy Followed by En-bloc Surgery
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- all randomized patients who are eligible and have started their allocated treatment (at least have been operated or received one fraction of irradiation followed by surgery)
- reporting Status
- POSTED
- time Frame
- From the date of surgery, up to 60 days following surgery
- title
- Perioperative Complications
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice