NCT03699761
Recruiting
Not Applicable
Evaluation of Pelvic Peritonization in Robotic or Laparoscopic Low Anterior Resection for Rectal Cancer
Southwest Hospital, China1 site in 1 country1,000 target enrollmentSeptember 1, 2020
ConditionsRectum Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectum Cancer
- Sponsor
- Southwest Hospital, China
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Grade III-IV complications
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
A randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.
Investigators
Tang Bo
Principal Investigator
Southwest Hospital, China
Eligibility Criteria
Inclusion Criteria
- •Matching the diagnostic criteria of rectal adenocarcinoma
- •Laparoscopic or robotic radical surgery for rectal cancer
- •Preoperative TNM staging T1-3N0-2M0
- •No history of malignant tumors by preoperative examination
- •Middle and low rectal cancer
- •Tumor size of 4 cm or less
- •ASA 1-3 scores
- •Written informed consent by the patient
- •The patient is willing to randomize to any group
Exclusion Criteria
- •Previous abdominal surgery
- •Past malignant tumor history
- •Preoperative examination suggests distant metastasis
- •Be participating or have participated in other clinical studies related to rectal cancer surgery within 6 months
- •Emergency operation
- •Elimination criteria
- •The tumor is confirmed to be T4b during the operation or other tumors are found to be combined with other tumors during the operation
- •The anastomosis is located above the peritoneum reflex
- •Intraoperative conversion to laparotomy
- •Change the surgical method to perform Miles or Hartmann surgery
Outcomes
Primary Outcomes
Grade III-IV complications
Time Frame: 30 days
The rate of grade III-IV complication according to Clavien-Dindo classification after low anterior resection
Secondary Outcomes
- Operation time(1 day)
- Treatment cost(30 days)
- LARS(12 months)
- Detection of other inflammation markers(7 days)
- Estimated blood loss(1 day)
- Acute inflammatory Response(7 days)
- Detection of inflammation markers(7 days)
- Overall complication rate(30days)
- Readmission rate(30 days)
- Rate of reoperation(30 days)
- Hospital time(30 days)
- The rate of anastomotic leakage(30 days)
- Postoperative bleeding(7 days)
- Intestinal obstruction(30 days)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Efficacy and Safety of Posterior Retroperitoneoscopic Adrenalectomy: A Comparative StudyAdrenal MassAdrenal DiseasePheochromocytomaCushing SyndromeNCT02618694Suez Canal University13
Unknown
Not Applicable
Robotic Versus Laparoscopic Low Anterior Resection for Rectal CancerRectal NeoplasmsSexual DysfunctionUrinary IncontinenceQuality of LifeNCT03209076Instituto Nacional de Cancer, Brazil120
Completed
Not Applicable
Robotic MIS With DexterHysterectomyPartial NephrectomyRight ColectomyNCT05537727Distalmotion SA100
Completed
Not Applicable
Assessing the Benefits of Robotic and Laparoscopic Surgery for Mid and Low Rectal Cancer in Patients: The Charlson Comorbidity Index (CCI)RoboticLaparoscopicAnterior Resection for Rectal CancerNCT06396845Daorong Wang505
Completed
Not Applicable
Comparison of Short-term Outcomes of Robotic and Laparoscopic Surgery in Patients With Different Body Mass Index for Mid and Low Rectal CancerRectal CancerNCT06396975Daorong Wang1,413