Treatment of Anastomotic Leakage After Rectal Cancer Resection

NCT04127734 | Unknown

• 1 other identifier: 2019-5849
• Study Type: observational
• Target: 1,246
• Locations: 0 countries
• Sites: N/A

Brief Summary

The TENTACLE: Rectum study is a multinational retrospective cohort study that includes patients with anastomotic leakage after rectal cancer resection. The study aims to develop an anastomotic leakage severity score and to evaluate the efficacy of different treatments of anastomotic leakage.

Conditions

Anastomotic Leak Rectum; Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 1-year stomafree survival

  Survival of the patient and absence of a stoma

  1 year

Secondary Outcomes (2)

• ICU length of stay

  1 year

• 1 year mortality

  1 year

Other Outcomes (8)

• Comprehensive complications index

  1 year

• Readmission rate

  1 year

• Reintervention rate

  1 year

Interventions

The efficacy of various interventions for anastomotic leakage after rectal cancer resection are investigated PROCEDURE

Investigated interventions comprise conservative, radiological, endoscopic and surgical (including stoma formation) interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive adult rectal cancer patients who have been operated between January 2014-December 2018 will be retrospectively analyzed and evaluated for an anastomotic leakage. All patients with an anastomotic leakage diagnosed within one year from primary surgery are suitable for inclusion.

You may qualify if:

• Aged 18 years or older;
• Cancer located in the rectum, defined according to the international definition of the rectum consensus \[D'Souza 2019\];
• Rectal cancer resection with primary anastomosis (with or without diverting loop ileostomy) for either primary cancer, completion after local excision or salvage resection for regrowth after watch \& wait or local excision;
• Postoperative anastomotic leakage according to the following definition: "a breach in a surgical join between two hollow viscera, with or without active leak of luminal contents" \[Peel 1991\].

You may not qualify if:

• Rectal resection for benign disease;
• Rectal resection for recurrent rectal cancer after previous low anterior resection or other primary malignancies;
• Multivisceral resection (lateral lymph node dissection can be included)
• Emergency resection;

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hans de Wilt, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frans van Workum, MD

CONTACT

0031621282881; frans.vanworkum@radboudumc.nl

Pieter Tanis, MD, PhD

CONTACT

0031629068275; p.j.tanis@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: April 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: September 30, 2021
• Last Updated: October 21, 2019

Record last verified: 2019-10