NCT02905968

Brief Summary

The purpose of this study is to evaluate the effectiveness of transanual tube placement in low anterior resection (LAR) for rectal cancer in preventing anastomotic leakage.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
520

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

September 8, 2016

Last Update Submit

September 14, 2016

Conditions

Rectal Cancer

Keywords

Anastomotic leakLow rectal cancer

Outcome Measures

Primary Outcomes (1)

  • anastomotic leak rate

    Anastomotic leak is a common and serious complication after low anterior, resection, and often leads to re-operation.

    30 days post operatively

Secondary Outcomes (1)

  • Time Frame: Reoperation rate after anastomotic leak

    30 days post operatively

Study Arms (2)

TTPLAR

EXPERIMENTAL

Transanual tube placement after anastomosis in low anterior resection for rectal cancer.

Device: transanual tube placement

NORLAR

NO INTERVENTION

Tranditional low anterior resection without transanual tube placement or ileostomy.

Interventions

transanual tube placementDEVICE

Transanual tube placement after anastomosis in low anterior resection for rectal cancer.

TTPLAR

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 and ≤ 75 years;
  • Primary tumor has undergone histologically confirmed rectal adenocarcinoma; Low rectal cancer was defined by the presence of the inferior pole of the tumor below the peritoneal reflection (in 11 cm from the anal margin).
  • Together with clinical or radiological evidence of Stage II (T3-4, N0, M0) or Stage III (T1-4, N1-2, M0) disease (according to the 2010 revision of the International Union Against Cancer primary tumor, regional nodes, metastasis (TNM) staging system).
  • Performance status (ECOG) 0\~1
  • Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; hemoglobin (Hb) ≥9g/dl (within 1 week prior to randomization)
  • Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either primary tumor, regional nodes, metastasis (AST) or ALT) ≤ 5 x ULN(within 1 week prior to randomization);
  • Written informed consent for participation in the trial.

You may not qualify if:

  • Body mass index (BMI) more than 30 kg/m2.
  • Serious pre-operative comorbidity, including cardiovascular disease (coronary arteriosclerosis, arrhythmia, heart failure), pulmonary dysfunction (lung emphysema, obstructive lung disease), liver insufficiency (Child-Pugh B or C), renal insufficiency (serum creatinine \>2.0 mg/dl), and arterial circulation disturbance (occlusion of arterial vessels of limb in patient's history.
  • History of accepting abdominal surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery, Zhongshan Hospital, Fudan University

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Rectal NeoplasmsAnastomotic Leak

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tuo Yi, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jianmin Xu, MD

CONTACT

008613501984869xujmin@aliyun.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 19, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

September 19, 2016

Record last verified: 2016-09

Locations

CN(1)