Sphincter preserving surgery after preoperative treatment for ultra-low rectal carcinoma. A French multicenter prospective trial: GRECCAR 1 P Rouanet, M Rivoire, B Lelong, E Rullier, L Vanseymortier, L Mineur, P Lasser, M Pocard, JC Ollier, JL Faucheron, F Dravet, D Pezet, JM Fabre, J Balosso, C Lemanski, S Gourgou, B Saint Aubert. GRECCAR (French surgical research group of rectal carcinoma).
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Sphincter preserving surgery after preoperative treatment for ultra-low rectal carcinoma. A French multicenter prospective trial: GRECCAR 1 P Rouanet,
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Sphincter preserving surgery after preoperative
treatment for ultra-low rectal carcinoma.
A French multicenter prospective trial:
GRECCAR 1
P Rouanet, M Rivoire, B Lelong, E Rullier, L Vanseymortier, L Mineur, P Lasser, M Pocard, JC Ollier, JL Faucheron, F Dravet, D Pezet,
JM Fabre, J Balosso, C Lemanski, S Gourgou, B Saint Aubert.
GRECCAR(French surgical research group of rectal carcinoma).
Inclusion: LRC which requires APRTIP - LA < 2 cm / UT2-T3
PA : Incidence of conservative surgery
SA : - Oncological and functional results
- Down staging impact on survival - Quality of life
Classification of AnoproctectomyBased on : - mucosal resection
- endoanal resection
ISR partial
PISR
ISR complete
CISR
Mucosectomy
M
Intersphincteric Resection
Ano-Proctectomy
Mucosectomy
Partial ISR
Complete ISR
GRECCAR 1 : inclusion curves
4/2001 – 4/2005 : 207 patients in 13 centers
0
10
20
30
40
50
60
70
80
VA CLB IPC StA COL CSC IGR CRG CPS Gren CF Mtpl CAV
0
5
10
15
20
25
30
35
40
2001 2002 2003 2004 2005
HDR
RCT
Effectives
RANDOMISATIONn: 207
HDRn: 106
RCTn: 101
Excludedn: 3
Non opern: 3
Excludedn: 3
Non opern: 2
n: 100 n: 96
Patient characteristics
Rt High Dosen = 100
Rt Chemon = 96
X2 / p
Sex M/F 66/35 64/33 0.93
OMS 0 92% 92% 0.81
Age* 60 (28-83) 64 (21-80) 0.065
weight* (kg) 73 72 0.64
height* (cm) 169 168 0.54
BMI* (Kg/m2) 25.2 25.5 0.87
*median Results at 23 monthsData base ended Feb 06
Tumor characteristicsHDR
n = 100RCTn = 96
X2 / p
Distance ITP-LA* 0.5 (0-3) 0.5 (0-5) 0.35
Fixity 29% 45% 0.015
Circumference > ½ 40% 42% 0.85
Distance ITP-PL* 1.1 (0-3.8) 1.2 (0-5.5) 0.72
Tumor height * 5 4 0.07
T3 66% 75% 0.47
N + 57% 59% 0.75
ITP-LA* 0.5 (0-3) 0.5 (0-6) 0.37
Tumor height* 5 4 0.15
*Median in centimetres
RE
Colo
US
R
Evaluation of neoadjuvant treatments
HDRn = 100
RCTn = 96
X2 / p
Delay Random / Rt 13 (0-37) 13 (8-111) 0.59
Total irrad anal canal 68% 69% 0.16
Symptomatic improvement 55% 61% 0.67
TR: tumour regression 80% 87% 0.26
Distance IP-LA* 1 1 0.74
Fixity 23% 14% 0.14
Circumference 45% 40% 0.55
U IP-LA* 1 (0-4.5) 1 (0-6) 0.43
U Height T* 4 3 0.29
*Median in centimetres
RE
US
R
Treatment toxicities Grade 3-4
HDR RCT
• Peri anal Dermititis 75% 44% p : 0.21
• Diarrhea 53% 40% p : 0.51
• Prostatitis 25% 20% p : 0.74
• Nausea 4% 8% p : 0.49
• Cystitis 18% 28% p : 0.34
• Failure to continue TTT 7% 0
average 5 d (2-15)
Surgery: Conservative rate 85%
HDRn = 100
RCTn = 96
X2 / p
Delay Rt / Surgery 37 (7-88) 44 (13-136) 0.0001
Delay > 4 weeks 76% 89% 0.012
Protection of pelvic Nerves
88% 88% 1
APR 17 - 17% 14 – 14.6% 0.69
APR in second time 4 (1R1/3C) 3 (2R1/1C)
AP - Mucosectomy 12 12
AP – ISR partial 35 27 0.60
AP – ISR complete 36 43
CAA J pouch 76% 77%
CAA coloplasty 8% 12%
CAA direct 13% 7%
72%
Incidence of Conservation in relation to Topography
TIP-LA Cons rate
• 0 very low 76 84%
• ≤ 2 cm low 120 84%
Incidence and distribution of APR by center
0
10
20
30
40
50
60
70
80
90
CLB IGR CF CPS CRG IPC VA SA COL
APRpatients
Operative morbidity
• According to pre op TTT HDR RCTFistula 9% 3% p : 0.13Pelvic abscess 2% 4 % p : 0.40Colonic necrosis 3% 3% p : 0.99Anastomotic stenosis 5% 4% p : 0.75
• According to type of surgery APR M P ISR C ISRFistula 1 (3%) 4 (19%) 4 (6.9%) 2 (2.6%)