UMIN-CTR Clinical Trial

Public title

Prospective study of diverting loop ileostomy in rectal cancer surgery

Acronym

Prospective study of diverting loop ileostomy in rectal cancer surgery

Scientific Title

Prospective study of diverting loop ileostomy in rectal cancer surgery

Scientific Title:Acronym

Prospective study of diverting loop ileostomy in rectal cancer surgery

Region

Japan

Condition

rectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to investigate the relationship between diverting loop ileostomy orientation and complication rate in the creation of diverting loop ileostomy for rectal cancer surgery.

Basic objectives2

Others

Basic objectives -Others

To assess complications after closure of diverting loop ileostomy.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To evaluate the rate of intestinal obstruction.

Key secondary outcomes

To evaluate fasting period, period until start of oral ingestion after surgery, nasal tube insertion period, period of tube insertion via ileostomy, necessity of operation for intestinal obstruction, the incidence of SSI, the rate of stoma-related morbidity, other postoperative complications, operation time, and bleeding volume.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with rectal cancer who will have diverting loop ileostomy.
2) Surgery is AR / LAR / ISR.
3) No history of surgery with intestinal resection (except for appendectomy).
4) No history of intestinal obstruction.
5) Age at the time of registration is 20 years or older.
6) Operable general condition, organ function.
7) Performance Status (ECOG) is either 0 or 1.
8) A written consent has been obtained from the patient for participation in the study.

Key exclusion criteria

1) Cases with the following serious complications
1: Poorly controlled diabetes
2: Uncontrolled heart failure, angina, hypertension, and arrhythmia
3: Interstitial pneumonia, pulmonary fibrosis, advanced emphysema
4: Continuous systemic administration of steroids.
2) Patients with psychosis are considered inappropriate to participate in this study.
3) Cases without a written consent.
4) Cases judged as inappropriate by doctors.

Target sample size

350

Name of lead principal investigator

1st name	Mizushima
Middle name
Last name	Tsunekazu

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

565-0871

Address

2-2, E-2, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3251

Email

tmizushima@gesurg.med.osaka-u.ac.jp

Name of contact person

1st name	Matsuda
Middle name
Last name	Chu

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterological Surgery

Zip code

565-0871

Address

2-2, E-2, Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3251

Homepage URL

Email

cmatsuda@gesurg.med.osaka-u.ac.jp

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

SCCRE

Address

2-2, E21-25C, Yamadaoka, Suita, Osaka, Japan

Tel

06-6879-3257

Email

miomikamori@gesurg.med.osaka-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学(大阪府)

Date of disclosure of the study information

2019

Year

09

Month

30

Day

URL releasing protocol

none

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/39516112/

Number of participants that the trial has enrolled

451

Results

Results: Small-bowel obstruction was observed in 10.8% in the nonrotated group and 12.3% in the rotated group, with no significant difference (P > .99). The only risk factor identified for small-bowel obstructionwas distance from the ileocecal valve, with a significant difference in 16 patients (7.3%) with a distance of <30 cm and 16 patients (15.4%) in a distance of >30 cm (P = .028).
Conclusion: Rotation of the diverting loop ileostomy had no significant effect on the incidence of smallbowel obstruction.

Results date posted

2026

Year

04

Month

04

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

This multicenter prospective study was conducted by the Clinical Study Group of Osaka University, which comprises 24 major institutions. Patients with rectal adenocarcinoma scheduled for laparoscopic/robotic low anterior resection or intersphincteric resection with a diverting loop ileostomy were included. A total of 451 patients were prospectively enrolled between July 2015 and April 2021.

Participant flow

Between July 30, 2015, and April 21, 2021, a total of 451 patients were prospectively enrolled in this study (Figure). Among these, 127 were excluded from the analysis (90 did not undergo diverting loop ileostomy, 18 had missing data, 11 underwent open surgery, 6 had a history of intestinal resection or small-bowel obstruction, 1 underwent proctocolectomy with ileal pouch-anal anastomosis, and 1 withdrew consent). Hence, only 324 patients were included in this analysis.

Adverse events

A small-bowel obstruction of grade III or higher according to the Clavien-Dindo classification occurred in 32 patients (9.9%). No recurrence was observed in these 32 patients. In 22 patients (68.8%), the obstruction possibly originated in the ileostomy site. Among the 32 patients, 6 underwent surgical treatment, which involved early closure of the ileostomy, whereas the remaining 26 showed improvement with conservative treatment with nasoenteric tubes, which was combined with tube insertion through the ileostomy in 17 patients. Small-bowel obstruction was observed in 23 patients (9.2%) in the nonrotated group and 9 patients (12.0%) in the rotated group, with no significant difference (P = .509) (Table IV). The difference was also not significant respect to the rates of small-bowel obstruction requiring revisional surgery, early small-bowel obstruction,21 and length of hospital stay between the nonrotated and rotated groups (2.0% vs 1.3%, P > .99, 7.6% vs 12.0%, P =.245, and 19.6 days vs 22.5 days, P = .935). The only risk factor identified for small-bowel obstructionwas distance from the ileocecal valve, with a significant difference in 16 patients (7.3%) at a distance of >30 cm and in another 16 patients (15.4%) at a distance of>30 cm.

Outcome measures

The primary endpoint was the relevance of loop ileostomy rotation to the incidence of small-bowel obstruction as determined by CT criteria, which include small bowel dilatation >3 cm in diameter without significant colonic dilatation and a transition point from dilated to collapsed small bowel. Contrast agents were also used when necessary for diagnosis. Small-bowel obstruction was defined as obstruction occurring prior to stoma closure or if stoma closure was not performed within 1 year after its creation, and classified as grade III or higher based on the Clavien-Dindo classification system. In this classification system, grade III requiring surgical, endoscopic, or radiologic intervention is further divided into grade IIIa, which requires intervention not under general anesthesia including a nasoenteric tube, and grade IIIb, which requires intervention under general anesthesia. The secondary endpoints included the origin of the small-bowel obstruction, revisional surgery of diverting ileostomy due to small-bowel obstruction, and length of hospital stay.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

05

Month

27

Day

Date of IRB

2015

Year

07

Month

30

Day

Anticipated trial start date

2015

Year

07

Month

30

Day

Last follow-up date

2022

Year

09

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

No longer recruiting

Registered date

2019

Year

09

Month

29

Day

Last modified on

2026

Year

04

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043487