CRP-guided Transanal Drainage Removal After Rectal Surgery

A Single Arm Study to Investigate the Safety and Efficacy of C Reactive Protein (CRP) Guided Transanal Drainage Tube (TDT) Removal for Anastomotic Leak (AL) Prevention Following Laparoscopic Anterior Resection for Rectal Carcinoma

Transanal drainage tube (TDT) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. Postoperative C-reactive protein (CRP) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (AL). Previously, TDT was removed at the surgeon's own discretion. In the present study, we design a single arm study to investigate the safety and efficacy of CRP-guided TDT removal for AL prevention following laparoscopic anterior resection for rectal carcinoma

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; Anastomotic Leak
• Intervention / Treatment: Device: removal of transanal drainage tube

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhiqiang Cheng, M.D. Ph.D.; Phone Number: +8618560085238; Email: hill988276@sina.com
• Study Contact Backup: Name: Xiang Zhang, M.D. Ph.D.; Phone Number: +8618560089182; Email: xiang.zhang02@hotmail.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital Of Shandong University
      • Contact: Xiang Zhang; Phone Number: +8618560089182; Email: xiang.zhang02@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age from 18 to 75 years old
• male and female
• primary rectal adenocarcinoma
• ASA I, II, or III
• laparoscopic LAR + DST
• with or without preoperative radio- or chemotherapy
• no distal metastasis
• no preoperative bowel obstruction
• no preventive ileostomy or colostomy
• patients and their families can understand and are willing to participate in this study and provide written informed consent

Exclusion Criteria:

• emergency operation
• preoperative abnormal liver function
• tatme or ISR procedure (healing process might differ from anterior resection)
• severe postoperative (Clavien-Dindo grade III IV V) complications other than anastomotic leak
• severe perioperative infection unrelated to anastomotic leak
• patients with serious mental illness
• pregnant or breastfeeding women
• patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with TDT removal guided by postoperative CRP trajectory	Device: removal of transanal drainage tube; removal of transanal drainage tube after laparoscopic anterior resection for rectal carcinoma according to postoperative CRP trajectory

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anastomotic rate	anastomotic rate	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the grades of anastomotic leak	The severity grading of anastomotic leak according to the International Study Group of Rectal Cancer	30 days after surgery
rates of diarrhea after transanal drainage tube removal	rates of diarrhea after transanal drainage tube removal	from transanal drainage tube removal to 30 days after surgery
visual analogue scale to assess anal postoperative pain	visual analogue scale of the included patients to assess the transanal drainage tube tolerability. Visual analogue scale ranges from 0-10. 0 indicates perfectly tolerated while 10 indicates complete intolerant and the tube has to be removed.	from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks
transanal drainage tube-related adverse events	transanal drainage tube-related adverse events such as bleeding and iatrogenic colonic perforations	from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Study Director: Kexin Wang, M.D. Ph.D., Qilu Hospital Of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: CRC-2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No