Clinical trial NCT04078828: PR in Endoscopic LAR for Rectal Cancer
Official title: Pelvic Floor Reconstruction (PR) in Endoscopic Low Anterior Resection for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Carcinoma
Keywords: minimally invasive surgical
Lead sponsor: Southwest Hospital, China
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium \& low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of leakage. However, PR in endoscopic LAR surgery is not routine practice and remains controversial. The purpose of this study is to evaluate the efficacy of PR during LAR for mid/low rectal carcinoma, especially in preventing anastomotic leakage.

Detailed description: Eligible patients with rectal cancer will be randomly assigned to group with pelvic floor reconstruction(PR) versus group without pelvic floor reconstruction(NPR).

We want to investigate the rate of anastomotic leakage and re-operation between the two groups, some other relevant outcomes will be concerned all the same.

Eligibility criteria: Inclusion Criteria:

1. patients with histologically proven rectal adenocarcinoma
2. tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection
3. Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI
4. Negative circumferential resection margin confirmed by MRI
5. Performance status (ECOG) 0\~1
6. Written informed consent for participation in the trial

Exclusion Criteria:

1. History of accepting lower abdominal surgery.
2. More than one colorectal tumor
3. Patients with unresectable distant metastasis or multiple metastases
4. Received neoadjuvant radiotherapy before surgery
5. Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
6. Patients and/or family members cannot understand and accept this study
7. Non-rectal adenocarcinoma was confirmed by postoperative pathological examination

Primary outcomes:
measure: The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer
timeFrame: 30 days after surgery
measure: Re-operation rate after anastomotic leakage
timeFrame: 30 days after surgery
measure: The rate of general complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Operative time
timeFrame: Operation day
measure: Postoperative hospital stay
timeFrame: 1 year after surgery
measure: Incidence of defecation dysfunction
timeFrame: From the date of operation until the date of complication,assessed up to 3 years
measure: 3-year local recurrence rate
timeFrame: From date of operation until the date of local-recurrence (up to 3 years)
measure: 5-year disease-free survival
timeFrame: From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
measure: Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire
timeFrame: 1 year after operation
measure: Blood loss
timeFrame: Operation day
measure: White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample
timeFrame: 1 days after surgery
measure: White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample
timeFrame: 3 days after surgery
measure: White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample
timeFrame: 5 days after surgery
Other outcomes:
Locations:
city: Chongqing
country: China
facility: General Surgery Center of PLA
state: Chongqing
Study officials:
References: