Clinical trial · Interventional

Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer

A Randomized, Prospective Trial of Robotic Versus Laparoscopic-assisted Radical Resection for Rectal Cancer in Urinary, Erectile Function and Anal Function

NCT02673177CI-TRIAL-00020791TRVLunknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study compared robot-assisted total mesorectal excision (RTME) and laparoscopic total mesorectal excision (LTME) with regard to urinary function, sexual function and sphincter- preservation outcomes for low rectal cancer.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Rectal Neoplasms	Rectal Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
laparoscopic total mesorectal excision	Procedure	—	UNRESOLVED
robot-assisted total mesorectal excision	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Robot-assisted total mesorectal excision
description
Robot-assisted total mesorectal excision (RTME) for rectal cancer. Two different RTME procedures were chose to personalized patients. Generally, when the tumor located within 5-15cm from the anal verge, low anterior resection (LAR) was employed, and tumor located below 5cm, abdominoperineal resection (APR) was applied usually.
interventionNames
1. Procedure: robot-assisted total mesorectal excision
type
ACTIVE_COMPARATOR
label
Laparoscopic total mesorectal excision
description
Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer was performed. The Urinary, sexual function and sphincter- preservation outcomes were evaluated.
interventionNames
1. Procedure: laparoscopic total mesorectal excision

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 70 Years

Show eligibility criteria text

Inclusion Criteria:

* 1\. Patients who are acceptable to two surgical procedures for the robot- assisted or laparoscopy-assisted rectal cancer, are willing to randomized trial;
* 2\. Matching the diagnostic criteria;
* 3\. Aged 18-70 years old;
* 4\. Preoperative TNM staging (CT, laparoscopic exploration): cT1-3N0-3M0 (excluding M1, T4);
* 5\. Preoperative ASA 3 scores;
* 6\. There was no history of malignancy, no other malignant tumors by preoperative examination;
* 7\. Without undergoing definitive treatment, such as radiotherapy, chemotherapy or immunotherapy preoperatively;
* 8\. The informed consent form was signed by the patient himself(herself)or his principal agent;
* 9\. In accordance with the international erectile function questionnaire (IIEF) urinary function scale, The urinary sexual function are normal.

Exclusion Criteria:

* 1\. Age less than 18 years old or more than 70 years old;
* 2\. Previous psychiatric patients or patients refused to sign the informed consent;
* 3\. Attending other related clinical studies on surgical treatment of rectal cancer;
* 4\. The patient has a history of malignant tumor, or a combination of other malignant tumors;
* 5\. Patients have been treated with definitive treatment: radiotherapy, chemotherapy or immunotherapy;
* 6\. Patients had received otherper abdominal operations (except for laparoscopic cholecystectomy);
* 7\. ASA \>3;
* 8\. Laparoscopic surgical contraindications: such as severe heart lung disease; abdominal wall hernia; diaphragmatic hernia; coagulation disorder; portal hypertension; pregnancy, etc.;
* 9\. Those who has been confirmed to be unable to do a radical resection (T4 stage) for local advanced tumor;
* 10\. Those who have urination sexual dysfunction preoperatively.

References

Publications (0)

Data not yet available

No reference posted for this study.