Robotic-assisted Versus Conventional Laparoscopic Approach for Rectal Cancer Surgery
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      This is a prospective randomized controlled study that was conducted on patients of both
      sexes and definite age group at National Cancer Institute-Egypt and with adenocarcinoma of
      the rectum located within 15 cm from the anal verge. Tumor localization was categorized as
      the upper rectum (distal border of tumor is from 10 to 15 cm from the anal verge), middle
      rectum (5 to 10 cm from the anal verge) or lower rectum (less than 5 cm from the anal verge)
      as measured by colonoscopy and digital rectal examination. Patients were classified into two
      groups; robotic assisted rectal surgery and conventional laparoscopic rectal surgery.Baseline
      demographics (gender, age, ASA, BMI), preoperative data (distance of the tumor from the anal
      verge, clinical stage, whether preoperative chemoradiation (CRT), presence of residual tumor
      after CRT, intraoperative data (preparation time, actual operative time, estimated blood
      loss, conversion rate to open surgery), postoperative data (pathological stage, number of
      harvested lymph nodes, macroscopic completeness of resection in the form of proximal margin,
      distal margin, circumferential radial margin) and immediate postoperative outcome within one
      month (days of return of bowel function, days of hospital stay, complications, if any, like
      anastomotic leakage, ileus,wound problems and others, rate of re-operation, rate of
      readmission & 30-days mortality) were analyzed and compared.The criteria for patients
      selection were the following: histological diagnosis of adenocarcinoma of rectum, no
      anesthesiological contraindications to minimally invasive surgery, age ≤ 75 years, American
      Society of Anesthesiologists (ASA) ≤ 2 & the procedures performed by the same surgical team.
      Patients with metastatic disease, malignant bowel obstruction and those with irresectable
      tumor were excluded from our study.Preoperative workup (endoscopy with biopsies, radiological
      imaging including pelvic MRI, liver ultrasound, chest X-ray and routine abdominal and digital
      rectal examinations) was routinely carried out. The assignment of patients to either group
      was done by a permuted block randomization. It was an open-labeled study. The study was
      approved by the institutional review board of National Cancer Institute-Cairo University. All
      patients provided written informed consent.
    

Detailed description: 
      Undoubtedly, robotic systems have largely penetrated the surgical field.For any new operative
      approach to become an accepted alternative to conventional methods, it must be proved safe
      and result in comparable outcomes. The purpose of this study is to compare the short-term
      operative as well as oncologic outcomes of robotic assisted and laparoscopic rectal cancer
      resection.

      This is a prospective randomized controlled study that was conducted on all patients of both
      sexes and definite age group attending the National Cancer Institute and with adenocarcinoma
      of the rectum located within 15 cm from the anal verge who were eligible to be included in
      the study. Tumor localization was categorized as the upper rectum (distal border of tumor is
      from 10 to 15 cm from the anal verge), middle rectum (5 to 10 cm from the anal verge) or
      lower rectum (less than 5 cm from the anal verge) as measured by colonoscopy and digital
      rectal examination. Patients were classified into two groups; robotic assisted rectal surgery
      "The robotic system that we use is the da Vinci Si(Intuitive Surgical, Inc.,Sunnyvale,CA)"
      and conventional laparoscopic rectal surgery. Baseline demographics (gender, age, ASA, BMI),
      preoperative data (distance of the tumor from the anal verge, clinical stage, whether
      preoperative chemo-radiation "CRT", presence of residual tumor after CRT), intraoperative
      data (preparation time, actual operative time, estimated blood loss, conversion rate to open
      surgery), postoperative data (pathological stage, number of harvested lymph nodes,
      macroscopic completeness of resection in the form of proximal margin, distal margin,
      circumferential radial margin) and immediate postoperative outcome within one month (days of
      return of bowel function, days of hospital stay, complications, if any, like anastomotic
      leakage, ileus, wound problems and others, rate of reoperation, rate of readmission & 30-days
      mortality) were analyzed and compared.The criteria for patients selection were the following:
      histological diagnosis of adenocarcinoma of rectum, no anesthesiological contraindications to
      minimally invasive surgery, age ≤ 75 years, ASA ≤ 2 & the procedures performed by the same
      surgical team. Patients with metastatic disease, malignant bowel obstruction (MBO) and those
      with irresectable tumor were excluded from our study. Preoperative workup (endoscopy with
      biopsies, radiological imaging including pelvic MRI, liver ultrasound, chest X-ray and
      routine abdominal and digital rectal examinations) was routinely carried out. The assignment
      of patients to either group was done by a permuted block randomization. It was an
      open-labeled study i.e. patients, investigators (surgeons, researchers) and data collectors
      knew which procedure will be done to which patients. The study was approved by the
      institutional review board of the National Cancer Institute, Cairo University. All patients
      provided written informed consent.
    

Intervention name(s): Total Operative time; Margin assessment; Conversion rate to open surgery; Baseline demographics; Preoperative data; Postoperative data
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Investigators compare the preparation time of the procedure in the operating room and the actual operative time; In this intervention investigators measure the proximal, distal and the important circumferential radial margin away from the tumor to determine if this arm is oncologically safe or not.; In this interversion investigators try to measure how much is this arm feasible to completely perform the procedure whether robotically or laparoscopically without conversion to open surgery; These include gender, age, ASA and BMI. All these data are analyzed and compared in both groups; These include distance of the tumor from the anal verge, clinical stage, whether preoperative chemoradiation "CRT", presence of residual tumor after CRT. All were analyzed and compared; These include pathological stage, number of harvested lymph nodes and immediate postoperative outcome within one month (days of return of bowel function, days of hospital stay, complications, if any, like anastomotic leakage, ileus,wound problems and others, rate of reoperation, rate of readmission & 30-days mortality. All were analyzed and compared
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment