Use of the TDT for Prevention of Anastomotic Leakage After Laparoscopic Anterior Resection for Rectal Cancer

NCT02686567 | Completed DMC

• 1 other identifier: TDT20160214
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

Anastomotic Leakage; Rectal Neoplasms

Keywords

transanal drainage tube; anastomotic leakage; laparoscopic anterior resection; rectal cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days after surgery

Secondary Outcomes (3)

• Grades of AL

  within 30 days after surgery

• Postoperative Anal Pain Score

  within 30 days after surgery

• Incidence of TDT-related Adverse Events: bleeding

  within 30 days after surgery

Other Outcomes (1)

• Incidence of DT-related adverse events : iatrogenic colonic perforations

  within 30 days after surgery

Study Arms (2)

with TDT

ACTIVE COMPARATOR

with TDT

Procedure: with TDT

without TDT

ACTIVE COMPARATOR

without TDT

Procedure: without TDT

Interventions

with TDT PROCEDURE

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.

Also known as: with transanal drainage tube

with TDT

without TDT PROCEDURE

After laparoscopic anterior resection and double-stapling technique anastomosis were finished, none additional proceduce was done.

Also known as: without transanal drainage tube

without TDT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

Daping hospital

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (7)

• 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.

  PMID: 21437746 BACKGROUND

• 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.

  PMID: 26231480 BACKGROUND

• 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.

  PMID: 26091985 BACKGROUND

• 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.

  PMID: 26665126 BACKGROUND

• 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.

  PMID: 26318026 BACKGROUND

• 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.

  PMID: 24378550 BACKGROUND

• 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.

  PMID: 34613330 DERIVED

MeSH Terms

Conditions

Anastomotic Leak; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Tong weidong, Professor

  Daping Hospital, Third Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of gastric and colorectal surgery, Daping Hospital

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: February 19, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)