Clinical trial NCT01985698: A Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for Treating Low Rectal Cancer
Official title: A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for the Curative Treatment of Low Rectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: Low rectal cancer
Robotic
Laparoscopic
Abdominoperineal resection
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.

Detailed description: Patients will be eligible for inclusion if their primary tumors is low rectal cancer.

Eligible patients will be randomly assigned to robotic-assisted (arm A) versus laparoscopic (arm B) abdominoperineal resection.

Eligibility criteria: Inclusion Criteria:

* Histologically proven rectal adenocarcinoma
* Inferior edge of the tumor located within 5 cm from the anal verge as determined by colonoscopy withdrawing and digital rectal examination
* No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc) according to ultrasound, CT, PET-CT, etc
* Tumor assessed as cT1-T3 or ycT1-T3 after preoperative neoadjuvant chemoradiotherapy by pelvic MRI
* No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
* Suitable for both robot-assisted and laparoscopic surgery
* American Society of Anesthesiologists (ASA) class I - III
* No other preoperative treatment except neoadjuvant chemoradiotherapy
* Informed consent

Exclusion Criteria:

* Tumors assessed as cT1N0 and suitable for local excision
* Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
* More than one colorectal tumor
* Familial Adenomatosis Polyposis, Lynch Syndrome, acute inflammatory bowel disease
* Schedules need for other synchronous colon surgery
* Absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class \> III)
* Pregnancy or lactation
* Patients and/or family members can not understand and accept this study
* Patients received chemoradiotherapy or other anti-tumor therapy before surgery

Primary outcomes:
measure: postoperative complications
timeFrame: 30 days post operatively
Secondary outcomes:
measure: operative mortality
timeFrame: 30 days post operatively
measure: disease-free survival
timeFrame: 3 years
measure: overall survival
timeFrame: 3 and 5 years
measure: locoregional recurrence rate
timeFrame: 3 and 5 years
Other outcomes:
measure: operative time
timeFrame: Day 1
measure: rate of conversion to open surgery
timeFrame: Day 1
measure: estimated blood loss
timeFrame: Day 1
measure: circumferential resection margin
timeFrame: 10 days post operatively
measure: proximal/distal resection margin
timeFrame: 10 days post operatively
measure: number of retrieved lymph nodes
timeFrame: 10 days post operatively
measure: postoperative hospital stay
timeFrame: 30 days post operatively
measure: self reported bladder function
timeFrame: at postoperative 3, 6 and 1 2 months
measure: self reported sexual function for male patients
timeFrame: at postoperative 3, 6 and 1 2 months
measure: self reported sexual function for female patients
timeFrame: at postoperative 3, 6 and 1 2 months
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jianmin Xu, MD
role: STUDY_CHAIR
References:
citation: Feng Q, Tang W, Zhang Z, Wei Y, Ren L, Chang W, Zhu D, Liang F, He G, Xu J. Robotic versus laparoscopic abdominoperineal resections for low rectal cancer: A single-center randomized controlled trial. J Surg Oncol. 2022 Dec;126(8):1481-1493. doi: 10.1002/jso.27076. Epub 2022 Aug 29.