Back to resultsUse of the TDT for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Rectal Cancer
Primary Purpose
Anastomotic Leakage, Rectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
with TDT
without TDT
Sponsored by
About this trial
This is an interventional treatment trial for Anastomotic Leakage focused on measuring transanal drainage tube, anastomotic leakage, laparoscopic anterior resection, rectal cancer
Eligibility Criteria
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
Sites / Locations
- Daping hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
with TDT
without TDT
Arm Description
with TDT
without TDT
Outcomes
Primary Outcome Measures
Incidence of AL
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 Outcome Measures
Grades of AL
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
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
TDT-related adverse events :bleeding
Full Information
NCT ID
NCT02686567
First Posted
February 15, 2016
Last Updated
May 4, 2021
Sponsor
Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02686567
Brief Title
Use of the TDT for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Rectal Cancer
Official Title
The Use of the Transanal Drainage Tube for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Medium & Low Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Leakage, Rectal Neoplasms
Keywords
transanal drainage tube, anastomotic leakage, laparoscopic anterior resection, rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
560 (Actual)
8. Arms, Groups, and Interventions
Arm Title
with TDT
Arm Type
Active Comparator
Arm Description
with TDT
Arm Title
without TDT
Arm Type
Active Comparator
Arm Description
without TDT
Intervention Type
Procedure
Intervention Name(s)
with TDT
Other Intervention Name(s)
with transanal drainage tube
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
without TDT
Other Intervention Name(s)
without transanal drainage tube
Intervention Description
After laparoscopic anterior resection and double-stapling technique anastomosis were finished, none additional proceduce was done.
Primary Outcome Measure Information:
Title
Incidence of AL
Description
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.
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Grades of AL
Description
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
Time Frame
within 30 days after surgery
Title
Postoperative Anal Pain Score
Description
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)
Time Frame
within 30 days after surgery
Title
Incidence of TDT-related Adverse Events: bleeding
Description
TDT-related adverse events :bleeding
Time Frame
within 30 days after surgery
Other Pre-specified Outcome Measures:
Title
Incidence of DT-related adverse events : iatrogenic colonic perforations
Description
DT-related adverse events : iatrogenic colonic perforations
Time Frame
within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tong weidong, Professor
Organizational Affiliation
Daping Hospital, Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Daping hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
after the paper published
Citations:
PubMed Identifier
21437746
Citation
Xiao L, Zhang WB, Jiang PC, Bu XF, Yan Q, Li H, Zhang YJ, Yu F. Can transanal tube placement after anterior resection for rectal carcinoma reduce anastomotic leakage rate? A single-institution prospective randomized study. World J Surg. 2011 Jun;35(6):1367-77. doi: 10.1007/s00268-011-1053-3.
Results Reference
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PubMed Identifier
26231480
Citation
Matsuda M, Tsuruta M, Hasegawa H, Okabayashi K, Kondo T, Shimada T, Yahagi M, Yoshikawa Y, Kitagawa Y. Transanal drainage tube placement to prevent anastomotic leakage following colorectal cancer surgery with double stapling reconstruction. Surg Today. 2016 May;46(5):613-20. doi: 10.1007/s00595-015-1230-3. Epub 2015 Aug 1.
Results Reference
background
PubMed Identifier
26091985
Citation
Shigeta K, Okabayashi K, Baba H, Hasegawa H, Tsuruta M, Yamafuji K, Kubochi K, Kitagawa Y. A meta-analysis of the use of a transanal drainage tube to prevent anastomotic leakage after anterior resection by double-stapling technique for rectal cancer. Surg Endosc. 2016 Feb;30(2):543-550. doi: 10.1007/s00464-015-4237-3. Epub 2015 Jun 20.
Results Reference
background
PubMed Identifier
26665126
Citation
Ha GW, Kim HJ, Lee MR. Transanal tube placement for prevention of anastomotic leakage following low anterior resection for rectal cancer: a systematic review and meta-analysis. Ann Surg Treat Res. 2015 Dec;89(6):313-8. doi: 10.4174/astr.2015.89.6.313. Epub 2015 Nov 27.
Results Reference
background
PubMed Identifier
26318026
Citation
Lee SY, Kim CH, Kim YJ, Kim HR. Impact of anal decompression on anastomotic leakage after low anterior resection for rectal cancer: a propensity score matching analysis. Langenbecks Arch Surg. 2015 Oct;400(7):791-6. doi: 10.1007/s00423-015-1336-5. Epub 2015 Aug 29.
Results Reference
background
PubMed Identifier
24378550
Citation
Nishigori H, Ito M, Nishizawa Y, Nishizawa Y, Kobayashi A, Sugito M, Saito N. Effectiveness of a transanal tube for the prevention of anastomotic leakage after rectal cancer surgery. World J Surg. 2014 Jul;38(7):1843-51. doi: 10.1007/s00268-013-2428-4.
Results Reference
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PubMed Identifier
34613330
Citation
Zhao S, Zhang L, Gao F, Wu M, Zheng J, Bai L, Li F, Liu B, Pan Z, Liu J, Du K, Zhou X, Li C, Zhang A, Pu Z, Li Y, Feng B, Tong W. Transanal Drainage Tube Use for Preventing Anastomotic Leakage After Laparoscopic Low Anterior Resection in Patients With Rectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2021 Dec 1;156(12):1151-1158. doi: 10.1001/jamasurg.2021.4568.
Results Reference
derived
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Use of the TDT for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Rectal Cancer
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