Anastomotic Leakage, Rectal Neoplasms
Conditions
Keywords
transanal drainage tube, anastomotic leakage, laparoscopic anterior resection, rectal cancer
Brief summary
The rate of anastomotic leakage after laparoscopic anterior resection（LAR） for medium & low rectal cancer is still high. the transanal drainage tube (TDT) was thought to be useful for deduce the rate. There were several studies, but most of them were not randomized controlled trial (RCT) studies. There was only one RCT study with enough samples, but it was designed for open anterior resection, and the patients underwent diverting stoma were excluded, so there was the selection bias. LAR now is thought to been with the same effect, and it is safe and feasible. So a RCT investigation for the use of TDT for prevention of anastomotic leakage after LAR for medium & low rectal cancer is needed.
Detailed description
Patients were randomly assigned to two groups, the TDT and non-TDT group after the laparoscopic LAR and DST procedure was decided during operation. Randomization was obtained through a computer-generated random number sequence allocation. Surgeon blinding was performed to ensure all the intraoperative decisions made by the surgeon were not interfered with by the grouping. All the operative procedures fully complied with the guideline for the diagnosis and treatment of colorectal cancer and the technique of total mesorectal excision (TME). The preservation of the left colonic artery was judged by the surgeon according to his own experiences and assessment of the patient's conditions. When the anastomosis was accomplished, the discretion of DS construction was made by the surgeon based on assessing the risk factors of AL. Pelvic drainages were used in all cases in this study. After completion of the anastomosis and further DS construction if necessary, the surgeon would be notified to implement the intervention based on the randomizing results.
Interventions
PROCEDUREwith TDT
After completion of the anastomosis and further DS construction if necessary, the surgeon would be notified to implement the intervention based on the randomizing results. In this group, a silicone tube (28Fr, Sumitomo Bakelite Co, Japan) was inserted through the anus and the tip of the tube was placed approximately 5 cm above the anastomosis at the end of the surgery in patients from the TDT group. The tube was fixed with a skin suture and connected to a drainage bag. TDT was planed to remove 3-7 days after surgery and early removal was allowed if the patient experienced intolerable pain.
PROCEDUREwithout TDT
After laparoscopic anterior resection and double-stapling technique anastomosis were finished, none additional proceduce was done.
Sponsors
Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
all consecutive 18 to 80 years old individuals diagnosed as primary rectal adenocarcinoma with the lower edge of the tumor less than 10 cm from the anal verge were considered eligible; with the classification of American Society of Anaesthesiologist (ASA) of I, II, or III; Laparoscopic LAR+ with double stapling technique (DST) was planned to perform for the patients. All the preoperative procedures should comply with the guideline for the diagnosis and treatment of colorectal cancer.
Exclusion criteria
The emergency operation for rectal cancer with obstruction, bleeding, or perforation would be excluded. Patients with inflammatory bowel disease (IBD), familial adenomatous polyposis (FAP), recurrent rectal cancer, or synchronous cancer would not be suitable. Patients with preoperative radiotherapy were excluded. Patients who underwent other types of surgeries for rectal cancer, including Hartmann's procedure, abdominoperineal resection (APR), intersphincteric resection ( ISR), et al. were excluded intraoperatively
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AL | 30 days after surgery | The primary endpoint was the AL within 30 days after surgery. AL is defined when the following symptoms were noticed: abdominal pain, fever, peritonitis, leukocytosis, procalcitonin (PCT) or c-reactive protein (CRP) increase, discharge of feces, pus, or gas from the drainage or vagina, septicemia with pelvic abscess. All clinically suspicious symptoms were confirmed by digital rectal examination, computed tomography (CT) scan or surgery when necessary. The severity grading of AL was defined according to the International Study Group of Rectal Cancer. In the present study, AL was referred to grade B and C, asymptomatic AL (grade A) was not considered because no active therapeutic intervention was required. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grades of AL | within 30 days after surgery | The grades of AL, including grade B, grade C. The severity grading of AL is defined according to the International Study Group of Rectal Cancer |
| Postoperative Anal Pain Score | within 30 days after surgery | Postoperative pain score. Numerical Rating Scale (NRS) for pains is used to assess the anal postoperative pain score of patients in the TDT group. NRS is the simplest and most commonly used scales for pain evaluation.The numerical scale is most commonly 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. (for the details, please see the literature below FERREIRA-VALENTE M A, PAIS-RIBEIRO J L, JENSEN M P. Validity of four pain intensity rating scales\[J\]. Pain. 2011, 152(10): 2399-2404) |
| Incidence of TDT-related Adverse Events: bleeding | within 30 days after surgery | TDT-related adverse events :bleeding |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of DT-related adverse events : iatrogenic colonic perforations | within 30 days after surgery | DT-related adverse events : iatrogenic colonic perforations |
Countries
China
Outcome results
None listed