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Search / Trial NCT05502354

CRP-guided Transanal Drainage Removal After Rectal Surgery

Launched by QILU HOSPITAL OF SHANDONG UNIVERSITY · Aug 12, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to decide when to remove a specific type of drainage tube (called a transanal drainage tube or TDT) after surgery for rectal cancer. The goal is to see if checking a blood marker called C-reactive protein (CRP) can help doctors determine the safest time to take out the tube, which may help prevent complications like an anastomotic leak (a type of surgical complication where the connection between two parts of the intestine leaks). The study is for adults aged 18 to 75 who are undergoing laparoscopic surgery for rectal cancer and do not have serious other health issues.

If you or a loved one are considering participating in this trial, you can expect to have regular check-ups to monitor your recovery and CRP levels. The researchers want to ensure that the drainage tube is removed at the right time to promote healing and avoid leaks. It's important to know that participation requires understanding and agreeing to the study, and there are specific health criteria to determine eligibility. Your involvement could help improve recovery processes for future patients undergoing similar surgeries.

Gender

ALL

Eligibility criteria

  • 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

About Qilu Hospital Of Shandong University

Qilu Hospital of Shandong University is a leading medical institution dedicated to advancing healthcare through innovative clinical research and patient-centered care. Affiliated with Shandong University, the hospital integrates clinical practice with education and research, fostering an environment that promotes scientific discovery and the development of new therapies. With a commitment to high standards of clinical excellence and ethical research practices, Qilu Hospital plays a pivotal role in enhancing patient outcomes and contributing to the global medical community through a diverse range of clinical trials and studies.

Locations

Jinan, Shandong, China

Patients applied

0 patients applied

Trial Officials

Kexin Wang, M.D. Ph.D.

Study Director

Qilu Hospital of Shandong University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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