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Gastrointestinal Diseases

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Rectal Diseases

robotic assisted rectal resection

laparoscopic rectal resection

Wai Lun Law, MBBS, MS

Wai Lun LAW, MBBS, MS

Hypothesis: the bladder and sexual functions can be better preserved in patients with robotic assisted rectal surgery

This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer.

This is a randomized trial comparing the bladder and sexual function of patients who undergo laparoscopic and robotic assisted rectal resection for rectal cancer

The primary objective of this study is to compare the bladder and sexual functions of patients who undergo laparoscopic and robotic assisted resection for rectal cancer through a randomized controlled trial.

The secondary outcome measures include

1. The operative outcome in terms of the complication rate, hospital stay and reoperation of the two groups;
2. The quality of life of the patients and the cost of the two groups
3. The quality of the resected specimens
4. The local recurrence rates at two years after the surgery

Randomized Trial on Robotic Assisted Resection for Rectal Cancer

Randomized Controlled Trial Comparing the Bladder and Sexual Functions of Patients Who Undergo Laparoscopic and Robotic Assisted Resection for Rectal Cancer

The University of Hong Kong

Professor Wai Lun LAW

open rectal resection

Jae Hwan Oh, M.D., ph.D.

The investigators designed the randomized prospective trial of comparing open and laparoscopic resection in locally advanced rectal cancer after preoperative chemoradiation in order to determine the oncologic and functional efficacy of laparoscopic rectal resection.

1. Title: A comparison for laparoscopically assisted and open surgery for advanced rectal cancer after preoperative chemoradiation - randomized prospective trial
2. Principal investigator: Jae Hwan Oh Co-investigator: Seung Yong Jeong, Sung Bum Kang, Hyo Seong Choi, Seok-Byung Lim
3. Purpose of the study: To compare efficacy of laparoscopic and open resection for locally advanced rectal cancer after preoperative chemoradiation
4. Specific aims

   1. comparison of oncologic outcomes
   2. comparison of quality of life
   3. comparison of anorectal function
5. Materials Rectal cancer \<9cm from anal verge, measured by rigid sigmoidoscopy histologically proven adenocarcinoma locally advanced (T3), determined by CT, transrectal ultrasonography, MRI without any contraindication for general anesthesia,operation and chemoradiation Completion of preoperative chemoradiation
6. Statistics

   1. Sample size calculation for non-inferiority trial: 340
   2. Disease free survival: Log-rank test,Cox regression analysis
   3. QOL and anorectal function: Repeated measured ANCOVA
7. Methods

   1. operation time of operation : 6-8 weeks after end of preoperative chemoradiation surgical technique standard total mesorectal excision and high ligation of inferior mesenteric vessels
   2. preoperative chemoradiation chemotherapy: 2 cycles of 5-FU (400 mg/m2/day) + LV (20 mg/m2/day) IV bolus, for 3 days in 1st \& 5th wks of RT or Capecitabine 825 mg/m2 p.o. bid during RT RT:45 Gy/ 25 fractions to the pelvis, 5.4 Gy/ 3 fractions boost to the primary tumor over 5.5 wks
   3. postoperative chemotherapy 4 cycles of 5-FU (400 mg/m2/day) + LV (20 mg/m2/day) IV bolus, for 5 days, 4 wks interval
   4. oncologic outcomes

      1. Short-term outcomes Surgical length of incision op time blood loss intraoperative complications conversion rate Pathological resection margins (proximal, distal, circumferential) number of harvested lymph nodes length of resected bowel tumor regression grade (Dworak's grading) TNM staging Perioperative recovery duration of use of parenteral narcotics initiation of peristalsis initiation of oral intake duration of hospital stay 30-day postoperative mortality morbidity
      2. Long-term outcomes Primary end point Disease free survival (3 years after surgery) Secondary end points Overall survival Local recurrence Distant metastasis Port-site and wound site recurrence
   5. Quality of life Urinary function Duration of urinary catheterization Residual urine volume at discharge International Prostate Symptom Score (IPSS) Male sexual function International Index of Erectile Function (IIEF) Female sexual function Female Sexual Function Index (FSFI) QOL assessment EORTC QLQ C30 EORTC QLQ CR38
   6. Anorectal function Anorectal manometry Maximum Resting Pressure Maximum Squeezing Pressure High Pressure Zone Sphincter Length Sensory Threshold Rectal Capacity Rectal Compliance Rectoanal Inhibitory Reflex Fecal Incontinence Severity Index (FISI)

Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer

A Comparison for Laparoscopically Assisted and Open Surgery for Advanced Rectal Cancer After Preoperative Chemoradiation- Randomized Prospective Trial

National Cancer Center, Korea

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Trial on Robotic Assisted Resection for Rectal Cancer	NCT01130233	Rectal Cancer Adenocarcinoma	robotic assiste... laparoscopic re...	18 Years -	The University of Hong Kong
Randomized Trial on Robotic Assisted Resection for Rectal Cancer	NCT01130233	Rectal Cancer Adenocarcinoma	robotic assiste... laparoscopic re...	18 Years -	The University of Hong Kong
Randomized Prospective Trial for Laparoscopic vs Open Resection for Rectal Cancer	NCT00470951	Rectal Cancer	open rectal res... laparoscopic re...	18 Years - 80 Years	National Cancer Center, Korea

Spots Global Cancer Trial Database for laparoscopic rectal resection