Day-Case Closure of Loop Ileostomy in Rectal Cancer

Day-Case Closure of Ileostomy: A Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Ileostomy Closure in Rectal Cancer
• Intervention / Treatment: Procedure: ileostoma closure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Sweden
  • Västerås, Sweden, 72189
    • Landstinget Västmanland,Centrum för klinisk forskning

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients earlier operated at the local hospital, who are now planned for closure of ileostomy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Rectal cancer patients with ileostoma; In association with anterior resection of rectal cancer these patients obtain loop-ileostoma in order to avoid complications. These are closed within a few months and according to previous studies the admission time is 3-5 days after operation. This study is a single-arm study. The arm include patients having had rectal cancer operation and who have obtained a loop-ileostoma and that meet the inclusion criteria. The operation procedure is standardized; shortly described by dissecting the ileostoma from the abdominal wall and everting the stoma ledges, which will be sutured or stapled. 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 be followed up.

Procedure: ileostoma closure; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with complications	30 days
Number of patients re-admitted	30 days
Number of patients re-operated	30 days
Number of patients who were able to return home after day-case closure of loop-ileostomy	24 houres

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Study Director: Abbas Chabok, Phd, MD, Centrum for Clinical Research Västerås/Uppsala University

Publications and helpful links

General Publications

• Afshari K, Nikberg M, Smedh K, Chabok A. Loop-ileostomy reversal in a 23-h stay setting is safe with high patient satisfaction. Scand J Gastroenterol. 2021 Sep;56(9):1126-1130. doi: 10.1080/00365521.2021.1947367. Epub 2021 Jul 5.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: Dnr 2014/363