NCT05502354

Brief Summary

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

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
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

August 11, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

August 11, 2022

Last Update Submit

November 19, 2023

Conditions

Rectal CancerAnastomotic Leak

Outcome Measures

Primary Outcomes (1)

  • anastomotic rate

    anastomotic rate

    30 days after surgery

Secondary Outcomes (4)

  • the grades of anastomotic leak

    30 days after surgery

  • 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

    from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks

  • transanal drainage tube-related adverse events

    from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks

Study Arms (1)

patients with TDT removal guided by postoperative CRP trajectory

EXPERIMENTAL
Device: removal of transanal drainage tube

Interventions

removal of transanal drainage tubeDEVICE

removal of transanal drainage tube after laparoscopic anterior resection for rectal carcinoma according to postoperative CRP trajectory

patients with TDT removal guided by postoperative CRP trajectory

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, 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

  • Kexin Wang, M.D. Ph.D.

    Qilu Hospital of Shandong University

    STUDY DIRECTOR

Central Study Contacts

Xiang Zhang, M.D. Ph.D.

CONTACT

+8618560089182xiang.zhang02@hotmail.com

Zhiqiang Cheng, M.D. Ph.D.

CONTACT

+8618560085238hill988276@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 16, 2022

Study Start

April 1, 2023

Primary Completion

December 31, 2024

Study Completion

February 1, 2025

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

CN(1)