Randomized Trial on Robotic Assisted Resection for Rectal Cancer

The University of Hong Kong (HKU)

Status and phase: Unknown; Phase 3

Conditions: Adenocarcinoma; Rectal Cancer

Treatments: Procedure: laparoscopic rectal resection; Procedure: robotic assisted rectal resection

Study type: Interventional

Funder types: Other

Identifiers

NCT01130233

UW 09-132

Details and patient eligibility

About

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.

Full description

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

Enrollment: 98 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically proven new case of rectal cancer with the lower border within 15 cm from anal verge
2. Age >18 years
3. Informed consent obtained
4. American Society of Anesthesiologist class 1-3
5. No contraindication to laparoscopic surgery
6. Acceptable operating risk

Exclusion criteria

1. Locally advanced fixed tumor with the need for exenterative surgery
2. Severe cardiac or pulmonary comorbidity rendering pneumoperitoneum hazardous
3. Multiple previous operations with the anticipation of dense peritoneal adhesions
4. No informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

98 participants in 2 patient groups

robotic

Experimental group

Description:

robotic assisted rectal resection

Treatment:

Procedure: robotic assisted rectal resection

laparoscopic

Active Comparator group

Description:

laparoscopic rectal resection

Treatment:

Procedure: laparoscopic rectal resection