Brief 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.

Trial Health

100

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Apr 2015

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

April 29, 2015

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2017

Completed

1.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2018

Completed

2 months until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed

Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

May 31, 2018

Last Update Submit

July 2, 2018

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

Operative time of robotic-assisted rectal cancer surgery.
Comparison of operative time in each arm
30 days postoperative

Secondary Outcomes (1)

Accurate safety margin
30 days postoperative

Study Arms (2)

Robotic-assisted Surgery Group

ACTIVE COMPARATOR

In this arm the investigators use a robotic system to perform resection of the rectum harboring the tumor trying to do that while being oncologically safe. The robotic system that we use is the da Vinci Si (Intuitive Surgical, Inc.,Sunnyvale,CA) Interventions used are total operative time, margin assessment, conversion rate to open surgery, baseline demographics, preoperative data and postoperative data

Procedure: Total Operative timeProcedure: Margin assessmentProcedure: Conversion rate to open surgeryProcedure: Baseline demographicsProcedure: Preoperative dataProcedure: Postoperative data

Laparoscopic Surgery Group

ACTIVE COMPARATOR

In this arm the investigators use a Laparoscopy system to perform resection of the rectum harboring the tumor trying to do that while being oncologically safe. Interventions used are total operative time, margin assessment, conversion rate to open surgery, baseline demographics, preoperative data and postoperative data

Procedure: Total Operative timeProcedure: Margin assessmentProcedure: Conversion rate to open surgeryProcedure: Baseline demographicsProcedure: Preoperative dataProcedure: Postoperative data

Interventions

Total Operative timePROCEDURE

Investigators compare the preparation time of the procedure in the operating room and the actual operative time