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Completed

NCT Number: NCT03958500

The Problem of Colorectal Anastomosis Safety

This is a prospective cohort pilot study. The investigators are planning to develop an original, standardized colorectal anastomosis inspection method, which will systemically inspect the anastomosis vascularity using the indocyanine green fluorescent angiography intraluminally and intraperitoneally, the air leak test, the methylene blue test, the tension in the anastomosis inspection, patients' risk factors scale sum. The summarized evaluation will determine the final anastomotic leak risk.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Adenocarcinoma Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute, Vilnius, Lithuania, Vilnius, Lithuania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients over 18 year
  • signed written consent
  • a colorectal anastomosis lower 15 cm from anal verge
  • elective surgery

Exclusion criteria

  • allergy to indocyanine green dye
  • pregnancy

Treatment and study plan

Indocyanine green fluorescent angiography intraluminally and intraperitoneally

Procedure

The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis

Other names: Air leak test, Methylene blue test

Primary outcomes

  1. Rate of anastomotic leakage

    Time frame: 0 to 60 days

    The number of patients, who had clinical or radiological anastomotic leakage. Proctography will be performed 6-8 days and 4-6 weeks after the primary operation.

Secondary outcomes

  1. Quality of life before and after the operation

    Time frame: 0 to 60 days

    Using low anterior resection syndrome score (the LARS score - simple 5 question questionnaire). LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).

  2. Quality of life before and after the operation

    Time frame: 0 to 60 days

    Using QLQ-C30 questionnaire. To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) before operation and 4-6 weeks after the operation.

    The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

    The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.

  3. Reoperation rate

    Time frame: 0 to 60 days

    Patients, who needed re-interventions

  4. Intraoperative test leakage

    Time frame: 0 to 600 minutes

    Leakage rate detected intraoperatively after anastomosis testing

  5. Time of anastomosis testing

    Time frame: 0 to 600 minutes

    Time from the start of the anastomosis testing till the end

  6. Operation time

    Time frame: 0 to 600 minutes

    Time from the start of the operation until the end of the operation

  7. 90 days mortality

    Time frame: 0 to 90 days

    the mortality of the patients after the operation

  8. Timing of anastomosis leakage

    Time frame: 0 to 60 days

    In days after surgery

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Collaborators

  • National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
  • Vilnius University Hospital Santaros Klinikos

Registry information

Official study title

Problem of Safety of Anastomosis in Colorectal Surgery and Search for the Solutions

Acronym: ANSCRS

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 22, 2019
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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