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CRP-guided Transanal Drainage Removal After Rectal Surgery

Recruiting
18 - 75 years of age
Both
Phase N/A

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Overview

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

Eligibility

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 details

Rectal Cancer, Anastomotic Leak

NCT05502354

Qilu Hospital of Shandong University

25 January 2024

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