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Completed

NCT Number: NCT02774447

Day-Case Closure of Loop Ileostomy in Rectal Cancer

The aim of this study is to investigate if day-case closure of ileostomy is feasible and safe.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Landstinget Västmanland,Centrum för klinisk forskning

Västerås, 72189, Sweden

About this study

For all patients that match the inclusion criteria a registration-protocol is completed. Then the patients are operated and a surgery-protocol is completed. The patients are observed for maximum 24 h and discharged if they meet the discharge-criteria. 30 days post-operative the investigators do a follow-up of complications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults not older than 80 planed for closure of ileostomy
  • The patient should not have had the ileostomy for more than 1 year
  • Informed written consent should be given
  • The patient should have a phone
  • Should have an adult supervision at home for the first 24 hours after discharge
  • American Society of Anesthesiologists (ASA) classification 1-2

Exclusion criteria

  • ASA classification 3 and above
  • The pre-operative investigation have shown anastomosis leakage or stricture
  • Dementia or other cognitive dysfunction
  • The need of an interpreter
  • Patients assessed not being able to manage themselves at home post-operative
  • Insulin treated diabetes
  • Coagulopathy
  • Other organ dysfunction
  • Bleeding more than 300 ml
  • If converted to laparatomy
  • Other intraoperative difficulties leading to suspected increased risk of complication

Discharge criteria:

  • Stable vital parameters regarding circulation and respiration
  • No sign of bleeding
  • Pain relief possible through per oral administration
  • Emptied urinary bladder
  • Able to maintain per oral nutrition
  • Mobilization possible
  • Obtained oral and written information about symptoms of sepsis and bowel obstruction
  • Obtained telephone number of a contact-nurse
  • Obtained time for wound-inspection at the surgical unit

Treatment and study plan

ileostoma closure

Procedure

The operation procedure is standardized as described above (see group description).The patients will be observed for 23 hours, and if there are no contraindications according to described criteria the patient can be discharged form the hospital, however all patients will have follow-up telephone contact on a daily basis with a nurse for the first week. Patients will meet the surgeon 3 days after discharge and after 4 weeks.

Primary outcomes

  1. Number of patients with complications

    Time frame: 30 days

  2. Number of patients re-admitted

    Time frame: 30 days

  3. Number of patients re-operated

    Time frame: 30 days

  4. Number of patients who were able to return home after day-case closure of loop-ileostomy

    Time frame: 24 houres

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Day-Case Closure of Ileostomy: A Pilot Study

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 17, 2016
Registry last updated
Apr 8, 2020

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.