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Completed

NCT Number: NCT01985698

A Trial of Robotic-assisted Versus Laparoscopic Abdominoperineal Resection for Treating Low Rectal Cancer

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic-assisted resection.

Procedure

Robotic-assisted abdominoperineal resection.

Laparoscopic resection

Procedure

Laparoscopic abdominoperineal resection

Primary outcomes

  1. postoperative complications

    Time frame: 30 days post operatively

    postoperative complications related to operation

Secondary outcomes

  1. operative mortality

    Time frame: 30 days post operatively

    death occurred 30 days after operation

  2. disease-free survival

    Time frame: 3 years

    disease-free survival rate at 3 years after operation

  3. overall survival

    Time frame: 3 and 5 years

    overall survival rate at 3 and 5 years after operation

  4. locoregional recurrence rate

    Time frame: 3 and 5 years

    local recurrence rate at 3 and 5 years after operation

Other outcomes

  1. operative time

    Time frame: Day 1

    Time from cutting the skin to suturing the incision during the surgery, recorded in minute

  2. rate of conversion to open surgery

    Time frame: Day 1

    The rate of patients actually receiving open surgery in robotic or laparoscopic surgery groups.

  3. estimated blood loss

    Time frame: Day 1

    Blood loss will be measured according to the suction and the weight of wet gauze, and then minus the irrigation.

  4. circumferential resection margin

    Time frame: 10 days post operatively

    The circumferential margin will be reported as "positive" or "negative" to define whether tumor is radically resected. It will be reported according to the post-operative pathology. Details are based on NCCN and Chinese guidelines for colorectal cancer.

  5. proximal/distal resection margin

    Time frame: 10 days post operatively

    The proximal/distal resection margin will be reported as "positive" or "negative" to define whether tumor is radically resected. It will be reported according to the post-operative pathology. Details are based on NCCN and Chinese guidelines for colorectal cancer.

  6. number of retrieved lymph nodes

    Time frame: 10 days post operatively

    It will be reported according to the post-operative pathology.

  7. postoperative hospital stay

    Time frame: 30 days post operatively

    The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.

  8. self reported bladder function

    Time frame: at postoperative 3, 6 and 1 2 months

    This section is assessed using a self-rating scale "International prostate symptom score" (IPSS)

  9. self reported sexual function for male patients

    Time frame: at postoperative 3, 6 and 1 2 months

    This section is assessed using a self-rating scale "International Index of Erectile Function" (IIEF-5).

  10. self reported sexual function for female patients

    Time frame: at postoperative 3, 6 and 1 2 months

    This section is assessed using a self-rating scale "Female Sexual Function Index" (FSFI).

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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

Acronym: RLAPR

Important dates

Study start
2013
Primary completion
2016
Study completion
2019
First posted
Nov 15, 2013
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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