Rectal Carcinoma
Conditions
Brief summary
The purpose of this study is to evaluate the safety and oncological feasibility of laparoscopy-assisted surgery for low rectal carcinoma compared with open surgery.
Interventions
Arm I: Patients undergo laparoscopic-assisted rectal resection.
PROCEDUREconventional open rectal resection
Arm II: Patients undergo conventional open rectal resection.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Nanfang Hospital, Southern Medical University
Peking Union Medical College Hospital
Peking University Cancer Hospital & Institute
Chinese PLA General Hospital
Liaoning Cancer Hospital & Institute
RenJi Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Second Affiliated Hospital, School of Medicine, Zhejiang University
West China Hospital
Shengjing Hospital
Fujian Cancer Hospital
The Second Affiliated Hospital of Fujian Medical University
The First Affiliated Hospital of Xiamen University
Zhangzhou Affiliated Hospital of Fujian Medical University
Longyan Affiliated Hospital, Fujian Medical University
Fudan University
Shanghai Zhongshan Hospital
Sun Yat-sen University
Hubei Cancer Hospital
Zhejiang Cancer Hospital
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* histologically proven rectal adenocarcinoma * inferior edge of the tumor located within 5 cm from the dentate line as determined by rigid proctoscopy * diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection or extralevator abdominoperineal excision * T3-4a,N0 or T1-4a,N1-2 treated with neoadjuvant chemoradiotherapy * no evidence of distant metastases * tumor size \<6cm * sufficient organ function * no contraindication to laparoscopic surgery * without other malignancies in medical history
Exclusion criteria
* concurrent or previous diagnosis of invasive cancer within 5 years * locally advanced cancers requiring en bloc multivisceral resection * intestinal obstruction * intestinal perforation * history of colorectal surgery * American Society of Anesthesiologists(ASA) class 4 or 5 * pregnant or breast-feeding women * history of mental disorder * participation in another rectal cancer clinical trial relating to surgical technique
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3 years disease-free survival | 3 years | Disease-free survival is defined as the time from date of surgery to the date of rectal cancer recurrence or metastasis or cancer-related death (locoregional or distant recurrence) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic outcomes | 1 week post operatively | Pathologic outcomes are defined as TME quality, negative CRM and negative DRM, length of proximal resection margin (PRM), length of DRM, and the number of retrieved lymph nodes.The TME quality was graded based on the criteria proposed by Nagtegaal et al. as complete, nearly complete, or incomplete.Positive resection margin, including circumferential resection margin (CRM) and distal resection margin (DRM), was defined as the presence of cancer cells within 1 mm from the cut edge. |
| 30-day postoperative complications | 1 month within operatively | Thirty-day postoperative complications included any complications occurring within 30 days after surgery. Postoperative complications were graded according to the Clavien-Dindo classification. Severe complications were defined as Clavien-Dindo III-V. |
| 30-day postoperative mortality | 30 days post operatively | Thirty-day operative mortality is defined as deaths occurring from any cause during the first 30 postoperative days. |
| Overall survival | 3 and 5 years post operatively | Overall survival is defined as the time from date of surgery to date of death from any cause. |
| Locoregional recurrence rate | 3 and 5 years post operatively | Locoregional recurrence was defined as the presence of any anastomotic, pelvic or perineal tumour documented by clinical and/or pathological examination. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Day 1 | Operative time is defined as the time from skin incision to the completion of skin suture. |
| Conversion to Open Surgery | Day 1 | The conversion is defined as any part of the mesorectal dissection using the traditional open surgery. The surgeon decided the conversion after considering patient safety, technical difficulties, and relevant conditions influencing the completion of TME. |
| Estimated blood loss | Day 1 | Estimated blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation. |
| Length of hospital stay | from the completion of the surgery till discharge from hospital | Duration of hospital stay measured from the day of surgery until the day of discharge from hospital. |
| Patient self-reported bladder and sexual function | at postoperative 3,6 and 12 months | Patient self-reported bladder and sexual function as assessed by the International Prostatic Symptom Score(I-PSS©) for male and female bladder function and the International Index of Erectile Function (IIEF) Female Sexual Function Index(FSFI©) for sexual function. |
| Health related quality of life | at postoperative 3,6 and 12 months | Health related quality of life assessed by EORTC CR29 score, EORTC CR30 score |
Countries
China
Outcome results
None listed